Focus Group Findings on the Migraine Patient Experience During Research Studies and Ideas for Future Investigations

Abstract

Objectives:

We conducted focus groups in people who had participated in mobile health (mHealth) studies of behavioral interventions for migraine to better understand: (A) Participant experience in the recruitment/enrollment process; (B) Participant experience during the studies themselves; (C) Ideas for improving participant experience for future studies.

Methods:

We conducted four focus groups in people who had agreed to participate in one of three studies involving mHealth and behavioral therapy for migraine. Inclusion criteria were being age 18-80, owning a smartphone, and having four or more headache days per month. All participants met the International Classification of Headache Disorders-3b criteria for migraine. Exclusion criteria were not speaking English and having done behavioral therapy for migraine in the past year. Focus groups were audio recorded, fully transcribed and coded using general thematic analysis.

Results:

The 12 focus group participants had a mean age of 45±15, a mean age of headache onset of 21±13 and mean MIDAS disability score was 39±56. Participants were women (100%), white (50%), Asian (33.3%) or members of other racial groups (16.7%). Certain themes emerged from each topic area. With regard to recruitment/enrollment (A), key themes were: (1) Participants joined their study out of an interest in research and/or a desire to try a new migraine treatment modality (behavioral therapy). (2) Enrollment should be simple and study requirements should be carefully explained prior to enrollment. When asked about their experiences during the studies (B), the following themes emerged: (1) It is difficult to participate in study follow-up and compliance phone calls. (2) Participants prefer to choose from among various options for contact with the study team. (3) There are barriers that limit app use related to migraine itself, as well as other barriers. (4) Completing diaries on a daily basis is challenging. (5) Technical difficulties and uncertainties about app features limit use. (6) Being part of a research study promoted daily behavioral therapy use. (7) Progressive muscle relaxation (PMR) is enjoyable, and has a positive impact on life. (8) Behavioral therapy as a preferred treatment to reduce migraine pain. Ideas for improving study design or patient experience (C) included: (1) Increased opportunity to interact with other people with migraine would be beneficial. (2) Navigating the app and data entry should be easier. (3) More varied methods for viewing the data and measures of adherence are needed. (4) More information on and more varied behavioral treatment modalities would be preferred.

Conclusion:

Though people with migraine are motivated to participate in mHealth and behavioral treatment studies, better communication up front about interventions as well as greater flexibility in interventions and follow-up methods are desired.

Introduction

Migraine affects over 36 million Americans and is the second most disabling condition worldwide. (1) While behavioral therapies have demonstrated efficacy for migraine prevention (Level A evidence). (2) , research has shown that there are barriers to patients accessing evidence-based behavioral therapies. Such barriers include the time it takes to attend behavioral therapy appointments and the cost of behavioral therapy. Mobile health platforms (mHealth) provide a patient-centered way to disseminate these treatments.

Guidelines provide expert-vetted information on the design of randomized behavioral clinical trials for headache disorders. (3) Existing literature in pharmacologic treatments has typically focused on preferences related to balancing drug side effects and various efficacy targets. However, there is limited information published on migraine patients’ perspectives on migraine treatment study design including study implementation, recruitment, and data collection. Although relevant to all human subjects migraine treatment research, this topic is particularly germane to behavioral treatments disseminated through mHealth strategies, as patients are the key stakeholders for all stages of this research.

Patient engagement and patient centered research are increasingly recognized as core components of effective research programs. The Patient-Centered Outcomes Research Institute (PCORI) was created as part of the Patient Protection and Affordable Care Act (2010)to fund patient-centered comparative effectiveness research. PCORI requires that the studies it funds address questions that are meaningful to patients and other stakeholders as well as measures outcomes that patients and other stakeholders find important. In addition, the Agency for Healthcare Research and Quality engages patients to help identify research areas, questions, and outcomes. (4) The National Institutes of Health and funding agencies in the United Kingdom also work with patients and advocacy organizations to set research priorities. (5,6)

The current study sought to describe migraine patients’ experiences during behavioral mHealth migraine treatment trials. These trials recruited participants from the settings in which migraine patients generally receive their care - the primary care setting, the neurology office and the emergency department - as research has found that the majority of people receive care for migraine outside of the neurology setting; 52.8% of all visits for migraine occurred in primary care settings, 23.2% in specialty outpatient settings, and 16.7% in EDs. (7) In fact, among women ages 15 to 64, headache was the third leading cause of ED visits in every year from 2011 through 2015 and headache (ICD 9 code 784) and migraine (ICD 9 code 346) were leading end-of-visit physician-assigned diagnoses. (8) Using the conceptual model on patient engagement and patient-centered research developed by Frank et al., we sought to examine (1) patients' feedback on the recruitment process into such studies (2) the patient experience during studies (3) participant feedback in how they might consider study design features. (9)

Methods

Participants

We conducted four focus groups with people with migraine meeting the International Classification of Headache Disorders (ICHD)-3b criteria (10). The participants were recruited from ongoing studies involving mHealth and behavioral therapy at an urban medical center. The participants had been recruited from three different ongoing feasibility/acceptability behavioral/mHealth trials taking place in the neurology, primary care and emergency departments of a large academic urban medical center. Inclusion criteria were: 1) aged 18-80, 2) has a smartphone, 3) had not participated in behavioral therapy for migraine in the past year, 4) ≥ 4 headache days/month.

Recruitment for focus groups was stratified to include participants who had fully participated (66.66%) as well as those who had withdrawn from studies (33.33%), to ensure that a broad range of perspectives were included.

The Behavioral Intervention

The studies we evaluated had common design elements but recruited from different settings. Each study identified ICHD-3 migraine. Participants went through an informed consent process which included description of study purpose and design. Once enrolled, participants were asked to complete a baseline questionnaire.. They were asked to download the RELAXaHEAD app, (11) modelled after the app used in the SMILE study which examined smartphone based PMR for epilepsy patients. (12,13) (it has the same PMR used in that study) and the Human Epilepsy Project (HEP) app. (14) The RELAXaHEAD app is compatible with both the Apple IOS and Google Android systems. There is an ~5-minute PMR session and an ~15-minute PMR session embedded in the app. For the RELAXaHEAD app, modifications were based on input from migraine patients and headache specialists using methods described elsewhere (11) Our RELAXaHEAD app has back-end analytics built in to record the amount of time spent playing the PMR. Patients were asked to track their headache attacks, medication intake/side effects, and sleep on a daily basis in addition to completing two PMR sessions. Participants could also access a diary feature that allowed for free-text notations to add qualitative information about their headaches and triggers. There were reminders sent out by the app at a fixed time daily. (They were supposed to be have delivered at the same time daily, but some phones allow the app reminder feature to be disabled.) Participants were asked to use the app daily for 90 days; they were asked to enter diary data and to perform PMR using the app for 20 minutes/day.

Participants were shown how to use the app, and twere then asked during the enrollment to input some data. Participants were given the rationale for PMR and were asked to practice it once in the office. The rationale was: “Relaxation will help you learn to control physical arousal and thus help prevent headaches. Research has shown that learning relaxation leads to fewer and less intense headaches for most migraine and tension-type headache patients so long as they regularly use and practice their skills.” (15) Patients were instructed that PMR would walk them through a specific set of procedures to learn how to tense and release various muscle groups throughout the body. All participants completed a full PMR session during the enrollment. Also, some participants were given study cards about the different aspects of the study procedures.

Of note, at the onset of the study, patients were told that they would be contacted once a month for a brief follow-up. It was sometimes hard to call at the exact preferred times but we made every effort to reach participants, making calls outside of business hours (evenings and weekends).Also, investigators could monitor noncompliance. There were protocol changes made after some initial study participants enrolled e.g. compliance calls for every three days of missing data were not part of the original protocol.

Focus Group Procedures

Participants were invited to participate in the focus group as follows: As stated above, there were three mHealth related studies using the RELAXaHEAD app. These studies differed from each other in that they recruited participants from different settings in which people with migraine present for care. In total, there were 21 participants invited from a study conducted of patients with migraine who had visited primary care, 39 participants invited from a study done of patients with migraine who had visited the neurology office and 61 participants who were contacted from an ongoing emergency department study. The patients recruited from the primary care and neurology settings had been the initial participants to enroll in the RELAXaHEAD studies and complete the six-month study period. In contrast, all of the ED participants who had been enrolled in the ED mHealth study (61) were invited to participate no matter whether or not the six-month study period had passed. A research coordinator called the participants up to five times to invite them to participate. If they could not be reached, an email invitation was sent to them. Participants were compensated $50 - $75 in the form of an Amazon gift card. All of the patients (61) recruited from the Emergency Department were contacted to participate in the focus group. Twenty-one of the enrolled primary care patients and 39 of the enrolled neurology patients were contacted.

Focus groups were conducted as follows (as detailed by the COREQ checklist):

The groups were led by MTM, a Board Certified Neurologist with subspecialty training in both Headache Medicine and Behavioral Neurology/Neuropsychiatry by the United Council of Neurologic Subspecialties. She has prior experience leading focus groups and has trained under a qualitative specialist. (16,17) Prior to the focus groups, she had not met any of the attendees with the exception of one who was coincidentally her patient (by the patient’s report to the group). She explained that as the PI, she was looking to improve the way in which research studies are done in the future and welcomed both positive and negative feedback in an effort to improve the patient experience in future studies.

The focus groups were also attended by a research team member who scribed and digitally recorded the session audio.

The semi-structured outline [Appendix 1] was used as a guide for leading the focus group and was developed based off the focus group template from focus groups “Helping Women Help Themselves to Improve Heart Health” conducted by a qualitative expert Dr. Victoria Dickson. She provided help in how to best structure such an outline.

At the beginning of each focus group, Dr. Minen introduced herself as a headache specialist and as the PI of the studies. She explained that the purpose of the focus groups was to learn about peoples’ experiences with the study and to gain ideas on how to improve the research experience. She asked for both positive and negative feedback. She also stated that all comments were confidential in that they should not be shared with others outside the room, and that the data from the focus groups would only be shared in aggregate form; there would be no identifying data published. No repeat interviews were carried out, and transcripts were not returned to participants for comment and/or correction.

The sessions were audio recorded, fully transcribed and coded using general thematic analysis using Atlas.ti 8 as follows: two coders, KM and KS, were trained in coding by MTM. Each coder individually developed a list of codes for each focus group, the coders then met and resolved discrepancies. MTM provided direction on how to do this, and both coders along with MTM developed the themes and subthemes for the study. The coders felt that data saturation was reached after three focus groups were completed and the data was analyzed. They found consistency between the data and the findings.

Results:

As seen in Table 1, there were a total of 12 focus group participants, 5 from the emergency department, 3 from primary care, and 4 from neurology. Of the total participants, 4 of them previously withdrew from the study, 1 from the emergency department, 1 from primary care, and 2 from neurology.

Table 1:

Participants’ Demographics and Headache and Related Characteristics

Participant Information	ED Participants; N=5	Neurology Participants; N=4	PCP Participants; N=3	Total Participants; N=12
Female:	5	4	3	12
Current Age: (Mean, SD, Range)	42±12 (30-63)	43±16 (27-60)	53±15 (34-70)	45±15 (27-70)
Started Having Headaches (Age) (Mean, SD, Range)	23 ±14 (10-39)	12±1 (10-13)	29±16 (15-51)	21±13 (10-51)
Race/Ethnicity; # (%)
White/Caucasian	2 (40%)	3 (75%)	1 (33.33%)	6 (50%)
African American	3 (60%)	0	1 (33.33%)	4 (33.33%)
Other	0	1 (25%)	1 (33.33%)	2 (16.66%)
Self-Reported Psych History; # (%)
Anxiety	3 (60%)	2 (50%)	3 (100%)	8 (66.67%)
Depression	3 (60%)	3 (75%)	1 (33.33%)	7 (58.33%)
PTSD	1 (20%)	0	0	1 (8.83%)
Positive Family History of Headaches	2	3	2	6
Headache Characteristics
# of Headache Days in the Past 3 Months	21±14(8-45)	48+29 (17-90)	42±36 (5-90)	35±29 (5-90)
Average Pain Intensity (0-10 Pain Scale) (Mean, SD, Range)	7 ±1 (6-9)	6±2(3-8)	6 ±1 (5-8)	6±2(3-9)
Current Pain Intensity (0-10 Pain Scale) (Mean, SD, Range)	6±4 (0-9)	4±3(0-7)	5±4 (1-10)	5±3(1-10)
MIDAS (Sum of First 5 Questions) (Mean, SD, Range, Median, IQR) Grade; # (%)	25±(5-68), 19, 34	67±76(10-217), 21, 106	24±18(10-50), 12, 40	39±56(5-217), 19, 26
1. 0-5	1 (20%)	0	0	1 (8.33%)
2. 6-10	0	1 (25%)	1 (33.33%)	2 (16.67%)
3. 11-20	3 (60%)	1 (25%)	1 (33.33%)	5 (41.67%)
4. 21+	1 (20%)	2 (50%)	1 (33.33%)	4 (33.33%)
Psychiatric Screens
PROMIS Depression (Sum) (Mean, SD, Range)	52+/−12 (38-70)	54+/−6 (45-60)	55+/−7 (51-62)	53+/−8 (38-70)
PROMIS Anxiety (Sum) (Mean, SD, Range)	59+/−14 (44-80)	54+/−12 (37-65)	54+/−8 (46-35)	56+/−11 (37-80)
Headache Healthcare Utilization
Number of prior ED Visits for Migraine, # (%)
0	0	3 (75%)	3 (100%)	6 (50%)
1	3 (60%)	1 (25%)	0	4 (33.33%)
2	0	0	0	0
3+	2 (40%)	0	0	2 (16.67%)
Previously Did Behavioral Therapy for Migraines? # (%)	0	2 (50%)	0	2 (16.67%)
Cognitive Behavioral Therapy	0	2 (50%)	0	2 (16.67%)
Biofeedback	0	0	0	0
Progressive Muscle Relaxation	0	0	0	0

Participants’ overall mean age was 45±15, their mean age of headache onset was 21±13 and their mean MIDAS disability score was 39±56. Participants were women (100%), white (50%), Asian (33.3%) or members of other racial groups (16.7%). Only 2 (16.7%) had previously done behavioral therapy for migraine. The emergency department participants were asked if they had a physician in an office setting who treats their headaches; only one answered yes. The primary care participants were asked if they had a neurologist; all answered that they only had a primary care doctor.

As seen in Tables 2-4, certain themes emerged from each topic area. Regarding recruitment/enrollment (A), key themes were: (1) Participants joined their study out of an interest in research and/or a desire to try a new migraine treatment modality (behavioral therapy) (2) Enrollment should be simple and study requirements should be carefully explained prior to enrollment. When asked about their experiences during the studies (B), the following ideas emerged: (1) It’s difficult to participate in study follow-up and compliance phone calls. (2) Participants prefer to choose from among various options for contact with the study team. (3) There are barriers that limit app use related to migraine itself as well as other barriers. (4) Completing diaries on a daily basis is challenging. (5)Technical difficulties and uncertainties about app features limit use. (6) Being part of a research study promoted daily behavioral therapy use. (7) PMR is enjoyable, and has a positive impact on life. (8) Behavioral therapy as a preferred treatment to reduce migraine pain. Themes around improving study design or patient experience (C) included: (1) Increased opportunity to interact with other people with migraine would be beneficial. (2) Navigating the app and data entry should be easier. (3) More varied methods for viewing the data and measures of adherence are needed. (4) More information on and more varied behavioral treatment modalities would be preferred.

Table 2:

Participant experience in the recruitment/enrollment process

Themes and Subthemes	Representative Quote
Interest in Research/Other Participants
Excited to Participate in Experimental Study	I wanted to contribute to the research, I wanted to help myself and other people.
Appreciated Research Being Done on Migraines	I like that someone is doing the research and trying to come up with ways to help people take responsibility for their own ways of coping with migraines.
Receptive to Joining Study With Other Migraine Sufferers	After like 2 weeks, I got a call telling me that they were doing headache research and that means it is serious, that other people have headaches and it is not just me. It's something serious; that's why I wanted to join.
Wanted to Reduce Migraine Pain with Behavioral Therapy
Curious if PMR Could Decrease Headaches	Well, I definitely suffer from tons of anxiety so I was kind of curious if muscle relaxation would help my headaches and help me feel better.
Recruited When Headache Treatment Was Priority	I was very excited about the idea because when I found out about the study I was having a lot of migraines, a lot of the time in the course of a month, and that’s what led me to go see a doctor to try to deal with it, rather than just band-aiding each headache, I wanted to really try to do something
Wanted to Try PMR Before Following Up with Neurologist Post-ED	I went to the ER and I had a to do a MRI, but then, because of the research, I didn't do that because I wanted to see how this goes. I was thinking maybe I should try this relaxation technique first.
Excited to Try Holistic Approach	When I was told about the study, it seemed like a great idea, try to take a more holistic approach.
Satisfied with Enrollment/Recruitment Process
Positive Experience During In-Person Enrollment	The actual enrollment process was very pleasant.
Understood Purpose/Requirements of Study	I think it was explained, certainly for me, very clearly what the expectation was.
Understood Different Types of Behavioral Therapy e.g. Difference Between PMR and Meditation	Moderator: So did you guys feel like you were explained at the beginning any difference between meditation, because you used the term meditation, and progressive muscle relaxation, or is there an understanding right now on whether they are the same or different? I would think they are different, but I can understand how colloquially they might sort of seem similar. But the progression of one by one making muscles relax, I definitely did understand that.
Positive Experience During Recruitment Via Phone	I first got a phone call, and they mentioned that they saw my records from my primary care doctor, and we had a nice conversation.
Require Simplification of Enrollment
Too Much Information Discussed During Enrollment	I felt like there were a lot of questions and we ended up sitting there for a really long time.
RA Training of Enrollment Should Be Enhanced	I think the person that enrolled me was sort of a first-timer, sort of one of the first people they were enrolling.
Headache on Day of Enrollment Caused Difficulties Remembering	But when we started the copy machine didn’t work and my headache was getting worse and worse. And she was very nice, but I’m not the kind of person who gleefully flips through the app and finds all the things. I think that, had I not had a headache, I take some ownership of the failure process to not say, okay it’s in the app.
Did Not Understand Purpose of Study	Moderator: Progressive muscle relaxation is level-A evidence-based treatment for migraine prevention traditionally done or taught by a psychologist, but the purpose of this study is to see if we can adapt it in a smartphone so that patients don’t have to take the time to go see a psychologist and pay them money and so forth? Or do you think that message was not there? I don’t think that was clear to me.
Need Simplification of Study Requirements	I honestly don’t think I understood the responsibility that I was taking on when I enrolled in the study. The journaling, my responsibility beyond doing the relaxation things.
Not Diligent in Reading All Enrollment Materials	And I think in retrospect, it would've been helpful for me, and again, you know, I apologize for not being as diligent reading all the material.
Unaware of Difference Between PMR and Meditation	I understood relaxation meditation as breathing. Because I tried to practice meditation before, but I can't just sit still and think about nothing. So I thought that breathing relaxation is a type of meditation for beginners. And this, I consider it as a breathing, but also sort of meditation. And, yeah, it wasn't that clear, probably.

Table 4:

Ideas for improving participant experience for future studies.

Themes and Subthemes	Representative Quote
Wants to Improve Functionality of App
Wants Easier Way to Input Data into Daily Diary
Diary Entries Should Auto-populate Based on Previous Entries	I wonder if it could learn from you, like some higher-level AI kind of thing. If it learned from your behavior after over time, and then could serve you up the more obvious. Like, if it needs to know your medication time, it could start to like sort of auto populate choices and things of that nature.
Prefers Fitbit (Or Other Technology) to Track Information	Maybe I need one of those Fit Bits that knows exactly what I’m doing and when I’m doing it.
Should Have Check Boxes for Diary Entries to Ease Data Entry	So, I wonder if, you know, to create some sort of consistency in the journaling, would it just be easy to check boxes, like; how does this feel, how does that feel, type thing. As opposed to just writing out more stuff, I guess.
Should Have Checklist in Medication Tab to Ease Data Entry	With the medicine – maybe if there was a way you to enter all your medicines and there was a whole list and you could just check on there instead of having to open up everyone.
Should Have Button to Click When Headache Starts/Stops to Log Duration	It would be easier to click when you started having the headache, instead of having to go in and enter each headache.
Should Have Voice Recognition in App for Diary Entries	I don’t like looking at a screen when I have a headache. So, I find it, it is more difficult, more annoying, because I have a headache to do that, maybe the typing, I don’t know if it was in there, but a voice recognition maybe would have been better.
Wants Additional Methods for Viewing Data
Wants Consistency in Tracking Different Measurements	I wonder if you know to create some sort of consistency in the journaling, would it just be easy to check boxes, like; how does this feel, how does that feel, type thing. As opposed to just writing out more stuff, I guess.
Wants to View Calendar by Month, Not Week	When the calendar comes up you can go week by week, well you can go month by month.
Wants Ability to Print Out Data Report	So now I’m think how I should be able to print out all my notes.
Wants More Help Navigating App
Should Redesign App to be More User Friendly	If you redesigned it so that there are buttons on the page, that might be a little easier to look at.
Should Have In-App Messaging to Study Team/Tech Support	On the app, like as you mentioned to improve it, like how we can have users contact you, maybe if there would be like some kind of chat or something. If users have an issue, they can just leave a message.
Should Have Tab in App for Technical Tips/Troubleshooting	Some sort of like tips, notifications in the app that could come up and say, “Would you like assistance on this?” Maybe that can even take the place of, not necessarily all of the human feedback, but it would certainly take back the possibility of people seeming pushy, or something like that as well, you know, feeling chastised.
Other
Should Track Food/Water Intake	I find that both water and food affect my headaches a lot. I realize that I have to drink water, um, on a regular basis probably more water than most people can tolerate I think in a day. It’s really important that when I get hungry to eat a little bit um, and if there’s a way of incorporating that in the survey, you know, at least for people who have the same um issues as I have.
Free Aspect Makes It Easier to Quit	But then again, if you're spending so much money to see a psychologist to help you with something like that all the time well then hopefully you would really stay invested.
Limit on How Much Patient Could Write in Notes Section	If you wrote for a certain period of time, maybe it wasn’t that, I don’t remember, but you couldn’t scroll down, and your keyboard would block the bottom half of what you were typing after a certain period of time.
Wants More Information on PMR
Wants More PMR Education Including Statistics	If you gave statistics like…and I know this is why you’re doing this study but like whatever research it is, it’s been found that there is 20% decrease on headaches, then maybe that could be included in your email or text message like remember! Because when you’re dying of a headache, that’s really motivating.
Emphasize Importance of Doing PMR Even When Migraines Improve	And I am pretty sure that the research associate when I had my first meeting, she may have said twice, you know, during the day. It wasn't really emphasized. And I think you should feel free to say it is really important to do it twice a day at the very least to get the maximum effect. You may find that, um, that you’re feeling better, so it’s tempting to slough off. But you should really do it twice a day.
PMR Preferred
Prefers to Do Long PMR
Prefers Long PMR	I actually really like the long one, I liked that it was kind of the same type of pace, but I like doing things slower, so forcing you to kind of pay attention to your body.
Longer PMR More Effective Because Muscle Groups Broken Down Slowly	Like you can tell the difference when it is the 5 minute one, they want you to relax like your arms, your back and your stomach all at once, whereas, on the longer one, it wants you to do it step by step so it’s more effective.
Shorter PMR Less Effective Because More Muscles Tensed at Once	With the short PMR, you are doing kind of a lot at the same time.
Prefers to Do Short PMR
Prefers Short PMR	I like the short one, its quick but it works. We are busy doing stuff that's why we have all these headaches, its only like 5, 6 minutes, it really works, where you are working on yourself, it really helps for me.
Wants to Do Multiple Sessions of Short PMR Daily	What I ended up starting to do when it started getting really hard to set aside those 20 minutes is that I would just use the 5 minute one maybe multiple times a day.
Suggests 2 Minute PMR	I feel like it wouldn’t feel like it was taking away from your day or your life as much if it was only 2 minutes, I can do anything for 2 minutes.
Able to Do 5 Minute PMR Anywhere	For example, the 5-minute meditation, you can do anywhere. You can do it at office you can do it at the train station. And it fits anywhere.
Prefers PMR to be 10 Minutes or Less	Moderator: What would be the ideal length of time in your mind? Less than 10 minutes.
Prefers to Do Both Long and Short PMR
Liked Combination of Short and Long PMR	I usually use the short, but I feel like you have to combine the short and the long together.
Did Both PMRs Back to Back	I would end up doing them back to back if I really wanted to make sure, I really need to do the 20 minutes, I would imagine it is not as helpful if it’s just 20 minutes on the same thing, versus the idea of doing one in the morning and doing one later.
Either Did Both PMRs or Neither	If I was going to do it, I had to do it right. I had to do the 5 and the 15 or I was not going to do it at all.
Wants Better Way to Track PMR Completed
Wants an App Functionality to Track PMR Sessions Completed	And would it be possible for it to show when we did the PMR? When you chose the headache day or no headache, there is a sign that appears on the calendar. Because sometimes I don't remember if did I did it? It would be nice to have icon there saying you did the audio.
Should Help Patients Set Goal to Complete Set Number of PMR Hours	Maybe if there was more of a goal-oriented aspect of this, or if we were to have learned, up front, that research tells us that you don’t see a benefit from this, but if you stick it out for a hundred hours cumulatively, you’re going to see an improvement, statistically what might happen.
Wants Options to Customize PMR
Wants to Do PMR Once Day	I would prefer once a day.
Prefers to Practice PMR on Own Without App Audio	I’m still using it right now, but I stopped listening to the exercise on the video.
Should Include More Variety of PMR Recordings	Maybe if there was um, like one, two or three versions of mediation where they were similar, let’s say, that participants can pick one of one of those? Because morning meditation I really like but the evening I had a couple days when I really was bored of her voice and I wanted to hear I want something different
Combined PMR with Other Forms of Relaxation	I felt there were other ways to relax, so I would do other things. I do something else called the Alexander Technique, which I think is a useful way of thinking about the use of my muscles and my body

Regarding the topic of recruitment/enrollment

One key theme was that patients wanted to participate because of an interest in the research/help other migraine sufferers. Many patients expressed that they were initially excited to participate in an experimental study and, as one patient explained what drew her into the study was some altruism, “I did want to contribute to the research, I did want to help myself and other people

Another key theme was that participants joined because of a desire to try a new migraine treatment modality (behavioral therapy) to reduce migraine pain. Many of the patients who joined the study were approached during a time when they were motivated to pursue treatment due to the severity of their migraines. One patient explained that, “I was very excited about the idea because when I found out about the study I was having a lot of migraines, a lot of the time in the course of a month, and that’s what led me to go see a doctor to try to deal with it, rather than just band-aiding each headache, I wanted to really try to do something.” One of the appeals of behavioral therapy in particular was that it was non-pharmacologic - one patient explicitly stated that she wanted to, “try to take a more holistic approach.”

Many participants were overall satisfied with enrollment/recruitment process. However, it was felt that the enrollment should be simple and study requirements should be carefully explained prior to enrollment. One patient stated that, “I felt like there were a lot of questions and we ended up sitting there for a really long time.” However, another issue during enrollment was that some patients felt liked they walked away without really understanding the requirements of the study and how to use the app. One patient said she was, “not the kind of person who gleefully flips through the app and finds all the things,” and thought that the person who enrolled her expected her to do just that. Another said that, “I honestly don’t think I understood the responsibility that I was taking on when I enrolled in the study. The journaling, my responsibility beyond doing the relaxation things.”

Regarding the topic of migraine patient experience overall

While many patients were satisfied with the study design and thus there was a theme “agreed with the current study setup,” another theme emerged that some participants wanted the study to be less of a time commitment. The study was designed to be six months long with most studies having follow up calls post-enrollment after 48 hours, 1 month, 2 month, 3 months and 6 months. During the first three months, if a patient did not listen to the PMR or enter data into the app for three consecutive days, they were contacted by the study staff. Thus, participants recommended shortening the length of the study from six months to three months. As one patient said, “6 months is kind of scary.”

Another theme that emerged was difficulty conducting follow ups/compliance calls via the phone. Some patients were not aware of the protocol in regard to compliance and were confused why or became stressed that they were receiving so many calls. One patient said that, “I would get phone calls that I hadn’t recorded the information and I found it very stressful.” Oftentimes, these calls would be at inopportune times, which would lead to a lot of back and forth between the patient and study team. As one patient explained, “Phone calls would always have to be rescheduled because I would always be busy at the time.” One solution to this problem emerged as a theme to have more choices in the form of follow up/compliance contact. While some patients wanted to continue to be contacted via phone, others preferred text or email or even a follow up visit.

Many of the patients wanted the study protocol to be updated to include opportunities to interact with other migraine sufferers. One of the main reasons was because these patients feel that non-migraine sufferers do not understand the severity of their pain. One patient said that she enjoyed attending the focus group because, “I like hearing other people’s stories; it is a little comforting to hear about other approaches or a shared experience.” All of these patients thought that in-person opportunities were best but acknowledged that it can be difficult to coordinate schedules; therefore, an online component could also be added.

Regarding the topic of the migraine patient experience in the studies

Another key theme was around barriers (both migraine as a barrier to using the app and non-migraine barriers to using the app) that inhibited app use.. Migraine pain often limited a patient’s ability to engage with the app; one patient explained that she was frustrated because she was, “having a lot of headaches at the time so my patience was limited. And it just seemed to me that each step along the way I ran into an additional obstacle.” Another patient said that it was difficult to speak on the phone whenever she had a migraine, which was why it was difficult to reach her for follow up/compliance calls. Barriers unrelated to migraine were also cited, such as discontinuing app use due to interruption in normal schedule, other medical issues, or disinterest/forgetfulness. One patient said that she stopped using the app when she went on vacation because, “I wasn’t going to take time out of my vacation, I could’ve been sitting on the beach doing it, I just wasn’t going to and then once I went back to work…I don’t have a good reason, I’d come home and do it for 5 minutes or 20 minutes but….” Some/many participants also disliked using the phone so frequently, or had concerns about sharing personal data through their mobile device..

Another theme that emerged was difficulty tracking information daily, with some participants stating that they only wanted to deal with pain days and did not want to track pain free days. One patient explained that, “I would rather do the work when I need to so I keep track of when I do have a migraine, I would write it down or do something to keep track and then I can report on that when I’m working with my doctor. But as far as doing something every single day, I would rather not do that. I would rather just deal with the pain days I think, than every single day.” One patient explained that she did not want to, “spend that much time every day dealing with the fact that I am migraine sufferer.” Another patient said that, “having to put information every day was tedious,” and, “what started driving me crazy with the app was the journaling every day, just trying to keep track of it.” Others felt that app functionality made it difficult to complete all of the study requirements. One patient stated, “I found the program itself a little bit awkward and again I'm not technological, but it was sometimes hard to enter the information or to go from, you know, place to place or to go back, you know, if I needed to change some things so that was a little challenging for me.” App functionality also included instances when the app would drain the phone’s battery or the app would freeze when opened.

However, some patients were interested in tracking information daily, particularly as it related to helping to identify their migraine triggers. One patient noted, “After the 5 minute meditation, I enter my sleep data, I put in all my medications, and I also start putting in notes because I am recovering from eating disorder. And I think it helps me because sometimes, if something triggers, I can go back and see what triggered my actions and what helps me. So I’m putting in all the data so I can go back and review.”

The participants also discussed uncertainty about app features, where they did not know how to track all features on the app and were unaware of the help section or data report. For instance, one patient stated that, “I didn’t understand what “medication side effect” was, maybe cause the medicine that I am taking doesn’t give me side effects that I know of. Again it feels like there was a lot of stuff.” They also noted that they sometimes ignored app notifications and were uncertain about these reminders because they felt that there were delivered inconsistently. One patient explained that the problem with the multitude of notifications was that, “I get lots of notifications from different apps on my phones and I tend to generally swipe them all left and sort of ignore them.”

Many of the patients enjoyed doing the behavioral therapy and believed that it had a positive impact on their lives. One patient said she was, “figuring out where the source of the headache was coming from, and this relaxation process definitely helped me do that.” Another noted that, “I had a very positive experience. My migraines really decreased, to the point where I would only need the meds every two and half months, three months maybe.” Some patients noted that being a part of the research study promoted PMR use because they wanted to provide data for the study and help other migraine sufferers.

Some patients did not enjoy using the PMR, most frequently referencing the long PMR session, because they found it difficult to focus for the designated length of time; one patient said, “The 15-minute relaxation video was hard to sit through, I would start dozing off. I have trouble meditating and focusing so that could just be me, but that 5 minutes was kind of like enough.” Another noted that, “It becomes particularly stressful to be there trying to force yourself to relax.” Others did not believe that the therapy would help alleviate their migraines, with one patient saying, “I think too much of me, is like; yeah right. I get that maybe it would work but, yeah sure, it works for somebody out there, but not me.”

Regardless of whether a patient enjoyed the therapy or not, all of the patients said that they needed time in their schedules to complete the daily PMR. Patients were most often unable to do so because of family and work obligations as well as difficulty finding a quiet space. The patients who were most successful completed the PMR sessions at the same time each day. One patient said, “I think it would really work much better if we build it into our daily schedule every day and earlier in the day. At least for me, I think if I could do that before I sort of, you know, before I go and do all my variable stuff during the day, I have a morning routine. And if I could include that in the morning routine I think that would help.”

Another barrier was that many patients stopped doing the PMR when their migraine attacks stopped. Some of the patients attributed the decrease in migraine frequency to the relaxation therapy. However, others found alternative therapies that worked better, and often quicker, for them. For instance, one patient explained that, “I started this study on the exact same day that I started the Botox treatment. And the Botox was so effective after a certain period of time, I think like 3 weeks in, that I was just amazed. I started feeling like I didn’t have to rely as much on other abortive medications, or the actual headache study.”

Feedback for Consideration of Future mHealth/Behavioral Studies for Migraine

During each focus group, the participants suggested how the study could be improved based on their experiences. From an mHealth perspective, patients were most vocal about wanting to improve the functionality of the app (in regards to inputting data into the daily diary, viewing previously entered data, and navigating the app). One patient, who thought check boxes were the best way to capture this information, said, “So, I wonder if, you know, to create some sort of consistency in the journaling, would it just be easy to check boxes, like; how does this feel, how does that feel, type thing. As opposed to just writing out more stuff, I guess.” Patients had the most difficulty tracking their medications since there were multiple steps required to confirm whether or not a medication was taken; this issue led one patient to suggest, “With the medicine – maybe if there was a way [for] you to enter all your medicines and [if] there was a whole list and you could just check on there instead of having to open up every one.” More high-tech suggestions included voice recognition and auto-populating the diary based in previous entries.

Since it was difficult to track information daily, patients wanted more opportunities to reach out throughout the study with questions on how to navigate the app. One patient, who noted that she is not tech-savvy, suggested an optional in-person follow up appointment after the initial enrollment. She explained that, for her learning style, “rather than a follow up phone call, I think I would have done better with a follow up visit so that I could have said; I don’t understand how to enter the medicine, or that I could have said why can’t I just enter it once if I’m taking the same drugs every night and every morning and for me, the opportunity to have a follow up visit a week later to have to opportunity to say: I don’t know how to do this, I don’t know how to do this, I don’t know how to do that, so then I could have the support, of you know, figuring out how to use the app better.” Another suggestion to help patients effectively use the app included an online chat through the app where patients could leave messages with their questions; a study team member would then respond directly through the app. One patient felt that the follow up/compliance calls, the time when most patient questions were answered, were very stressful; her solution was to include, “some sort of like tips, notifications in the app that could come up and say, ‘Would you like assistance on this?’” Maybe that can even take the place of, not necessarily all of the human feedback, but it would certainly take back the possibility of people seeming pushy, or something like that as well, you know, feeling chastised.”

From a behavioral perspective, the majority of the patients had difficulty completing twenty minutes of PMR daily. Barriers included both their headaches as well as outside commitments. Most patients had an opinion on which PMR they preferred; for some patients, it was the short PMR, and they suggested doing multiple short sessions a day. One patient shared, “I remember thinking: I wish there was just a really quick one, just like two minutes. One, two, three, just go through the steps and listen to that and be done with it.” However, other patients preferred the long one, and several liked that there was variety in that they had both long and short PMR options in the app. Additionally, participants thought that the PMR recordings became repetitive after a few weeks and wanted options to customize the PMR in order to remain engaged; as a possible solution, one patient said, “Maybe if there was um, like one, two or three versions of meditation where they were similar, let’s say, that participants can pick one of one of those? Because morning meditation I really like but the evening I had a couple days when I really was bored of her voice and I wanted to hear I want something different.” Another barrier that inhibited patients from completing the daily PMR was if they forgot whether or not they had already done so that day. Therefore, patients wanted a better way to track PMR completed on the app; one patient suggested a note in the diary calendar when a session was completed.

Many of the patients also felt that they were not given enough instruction on the benefits of PMR and the difference between this therapy and meditation. They wanted more information given on PMR during enrollment and reinforced throughout the study. When the moderator of the focus group asked participants if they understood how behavioral therapy was different, a majority had trouble distinguishing the two. One patient suggested providing more statistics on the impact of PMR; she said, “If you gave statistics like…and I know this is why you’re doing this study but like whatever research it is, it’s been found that there is 20% decrease on headaches, then maybe that could be included in your email or text message like remember! Because when you’re dying of a headache, that’s really motivating.”

Discussion:

This qualitative study of focus group participants previously enrolled in mHealth studies of behavioral interventions revealed several themes important for consideration of why people with migraine enroll in research studies as well as what should be considered when designing future studies. First, people enroll because they have an interest in research and/or a desire to try a new migraine treatment modality. Second, the enrollment process needs to be clear and simple, should be educational in that the purpose and any pre-existing data on the intervention be provided, and should include all study requirements in addition to expectations about compliance, barriers that might interfere with compliance, and study protocol steps in cases where compliance may be limited. Third, when designing these studies, participants prefer choice; this could be choice in how often and/or by what means follow-up or compliance calls are done, or even perhaps choice in which behavioral treatments might be done. Fourth, some people prefer to track their data daily and others do not prefer to perform daily tracking of their data. However, even if people do not like daily tracking, they may like reminders. Fifth, when using apps, the app functionality needs to be clear and any technological glitches minimized.

First, people with migraine enroll in migraine behavioral interventional studies out of an altruistic desire to improve general knowledge about migraine and treatment options for others with migraine, as well as a desire to try a new non-pharmacologic treatment modality. This is unsurprising and in line with prior research on migraine patients. (18,19)This is consistent with prior qualitative research has shown that people with migraine have difficulty adhering to abortive medications and are often interested in exploring options for managing their headaches that do not have adverse side effects.

Second, the recruitment/enrollment process needs to be simple and clear. For example, the recruitment process needs to clearly include educational information explaining the purpose or rationale of the study as well as any pre-existing evidence behind the intervention being study. In our studies, we waited until the enrollment process to give an in depth description of the PMR rationale from the book by Smitherman et al. on Headache Treatments. (15) Patients were instructed that PMR would walk them through a specific set of procedures to learn how to tense and release various muscle groups throughout the body. Frank conceptualizes four factors common to all therapeutic experiences: rapport, a healing setting, a treatment rationale, and a behavior in which the patient engages in order to heal. (20) Aligned with this conceptualization, patients reported that the rationale was not sufficient in the current study procedures to convince them to engage in the healing behavior. Perhaps participants need to be explained the rationale early on in the recruitment process-not just in the enrollment process. It is possible the literacy of the education was too high. It is also possible that the rapport was not established to support the treatment rationale in the settings from which we recruited patients. Finally, the theme of individualization continues to emerge throughout the focus groups; it is possible that the education materials were not sufficiently tailored to patient experiences, and therefore did not seem relevant to their lives and their disease. Future studies might need to address these factors.

The informed consent process might also be improved, as some focus group participants indicated that their consent may not have been fully informed, a common problem in all of medicine and medical research. Participants stated that they wanted clear information upfront on all of the study requirements. We had study cards for what participants should expect when enrolled in the study, but perhaps study cards such as brochures are not always accessed or safely kept for consultation at later dates. Future studies should ensure that relevant study procedures are easily accessible through study apps, so that patients may access the information at any time.

It is not surprising that some participants voiced that they were not fully aware of all of the study requirements. Informed consent documents are written, in part, as legal liability-limiting documents rather than understandable documents that let participants know exactly what to expect. Prior research shows that optimal informed consent procedures can be developed using focus group interviews with people in a target population, and that it is an iterative process to develop valid informed consents. (21) Typically, prospective studies provide participants with written information about the planned study but verbal information usually accompanies this by a healthcare professional or researcher. While the value of providing written information for informed consent is accepted, it has been found to be weak in its purpose-to truly inform participants about the research. (22) This may be why other methods are sometimes used to inform study participants about the planned study. (23) However, a systematic review showed that enhanced consent forms were among the most effective. (24) Thus, future migraine research might use focus groups or other participatory methods to ensure that participants fully understand what is being asked of them.

In addition, since these were feasibility acceptability studies, as indicated in the methods section, there were protocol changes made after some initial study participants enrolled. At the onset of the study, patients were told that they would be contacted once a month for a brief follow-up. However, once the team realized that there were some compliance issues, patients that were noncompliant in filling out the daily diary or completing PMR were contacted after three days of missed data. Patients were unaware of the changes made to the protocol surrounding non-compliance, and in the focus group, it became apparent that many patients felt that they were receiving too many calls, which caused them stress. Thus, to minimize compliance issues, patients should be advised from the start that compliance is an important component of the study. If patients are aware that they are being regularly tracked, they will expect to be contacted if non-compliant. (25) For app-based studies, phone calls may be perceived as unnecessarily intrusive. Alternative messaging should be incorporated to monitor and improve compliance.

Our study results suggest that participants want to understand study requirements at the time of enrollment. In exploratory or pilot feasibility/acceptability studies, when protocol modifications are required, this can challenging. The Medical Research Council’s 2000 framework for the development of complex interventions to improve health includes an exploratory trial design to address issues of optimization, acceptability and delivery of the interventions. This design permits “adaptation of the intervention, consideration of variants of the intervention, testing and refinement of delivery method or content, assessment of learning curves and implementation strategies and determining the counterfactual.” The National Center for Complementary and Integrative Health (NCCIH) also suggests the use of pilot studies to address questions of feasibility. Examples include, “Can the treatment(s) be delivered per protocol?” and “Are the assessments too burdensome?” Thus, in order to optimize the treatments and/or assessments, protocol changes may need to be made. A systematic review of guidance for exploratory studies found that there is little consistency in guidance regarding exploratory studies, and more specifically that there is some guidance that changes can be made for refining the intervention, but “guidance was not clear on what constituted minor vs. major changes.” The authors stated “that an intervention continues to develop throughout an exploratory study, with distinctions made between ‘optimization/refinement’ (i.e. minor refinements to the intervention) vs. ‘major changes’. However, the point at which changes become so substantial that movement back toward intervention development rather than forward to a full evaluation remains ambiguous.” Thus, likely on an individual study basis, researchers need to consider patient burden and patient expectation regarding the changes, and they need to consider to what extent participants should or need to be informed of the changes.

Participants cited various types of barriers to comply with the studies, and such barriers can be divided into migraine related barriers and non-migraine related barriers. Migraine related barriers include not wanting to speak during an attack, thus limiting the ability to answer study related follow-up or compliance calls, not wanting to enter data during an attack, and more. The time frame for answering diaries must take into account the episodic nature of the attack, and should permit the person with migraine to complete the information for a window of several hours to enhance compliance with the diary during and in-between migraine attacks. Researchers should expect scheduled research visits or calls to be interrupted by unpredictable migraine attacks, and should build in contingencies to ensure that rescheduling research contacts is not onerous for the participant. Also, strategies like suggesting darkened screens on phones might be helpful for people who have photophobia and want to limit screen time during attacks.

There were non-migraine related barriers as well. While the studies sought to deliver behavioral therapy via a mobile app in order to reduce the amount of time that patients needed to spend receiving treatment and eliminate the time needed to travel to and from appointments, many patients were still unable to complete the required twenty minutes of PMR daily due to outside commitments. A previous study examining the effect of CBT for pediatric migraine showed that 28% of patients approached refused to participate in behavioral therapy due to lack of time or potential stress while only 2.8% refused to participate because they did not want to take medication. (26) Many of these participants admitted that therapy was only a priority on the days when their headache attacks were severe, even though relaxation therapies are conceptualized as preventive treatment one uses daily to reduce the frequency of headache attacks. According to the Stage of Change Model, a patient must be ready and motivated in order to adhere to the study regime (27). Motivational interviewing might be an appropriate intervention to enhance motivation to change. Behavior change intervention studies should consider accepting only patients who reach the preparation or action stages of change during the enrollment visit into the study. If this is done in an effort to increase efficacy (at the expense of generalizability), steps might be taken during the recruitment process to ensure that enrolled patients are ready to make these changes. When the results are reported, there should be clear reporting of the inclusion and exclusion criteria so that readers understand the study population and any limitations regarding the generalizability.

Diary collection must be fast, easy, and unobtrusive. While some participants found the diary entries helpful for tracking headaches (2) and used the app to follow their migraine triggers (9), the majority of participants thought that this component of the study resulted in too many study requirements (13) and did not want to have to use the app daily (5). Others were unsure of how to use some of the tracking features (13), which limited their participation in the study. Thus, there are individual differences that patients report, and missing data may not be at random. While we did not ask participants about the extent of their missing diary data, difficulty in tracking daily symptoms was not limited to these studies. A previous study which used an application to track medication adherence among pediatric patients estimated that rates of error resulting in missing data ranged from 0 to 24%. (28) Incentives for daily completion of diary entries must be enhanced to ensure compliance. Cues to complete the diary should be set for times the patient prefers, and reminders should occur at several points in time during the completion window.

Participants also shared ideas for how to improve app functionality. User engagement and app functionality are essential elements in smartphone diary usage. Prior research has already shown that there is limited use of apps in that 21% of people who download an app will only use it once let alone for an extended period of time. (29) In addition, there must be a way for participants to be able to report technological difficulties and thus there must be ways to trouble shoot any of these issues. In these studies, the participants could email or call the research team to report any issues and to trouble shoot, and any unresolved issues would then be reported to the app company. This was a similar process to what was done in a recent pediatric headache diary study. (28)

Prior studies also show that participants report wanting varied methods of communication with the study team. For example, for communicating study results to patients at the end of the clinical trial, most patients (80%) would like to receive this information in a letter, while others would like a presentation made by the investigator to a group of participants. On the other hand, some would like to hear about the results via a telephone call. Therefore, steps should be made to accommodate patients based on their preferences. In each instance, patients are seeking a more personalized approach. (30) Our data indicates that methods of contacting the participants should be diverse and tailored to patient preferences. At the same time, we realize that choice limits internal validity of studies. Thus, we want people to all be doing the same protocol within given arms of a study. We need to consider study designs that allow for the individual differences of patients and different choice in treatment modality, without sacrificing internal validity. This is especially true because at the end of the study, if we do not have the data from participants because they were non-adherent or drop out, it affects the study’s internal validity.

In terms of the behavioral treatment itself, for those who did the PMR, they stated that the PMR exhibited a positive impact on the lives of many of the participants in a variety of ways, such as reducing headache frequency (3), determining the source of their headaches (10), or simply helping them focus (2). Patients that did not use the PMR regularly, and thus did not see these changes, often attributed their noncompliance to taking another medication that reduced their headaches (10), limited time to complete both PMRs daily (7), and redundancy of the therapy (3). A previous study examining electronic behavioral interventions for headaches shared similar problems with adherence and suggested having periodic booster sessions or involving the patient’s family in order to increase the potency of treatment (16 Minen, M., 2016). Patients also stated that they would have preferred to have more than two behavioral audio practices to maintain their interest. This is interesting, as most of the prior migraine behavioral treatment studies utilized a myriad of behavioral techniques, even if they were all grouped together as being cognitive behavioral therapy. (31,32) Thus, patient preference in treatment selection is key. Even highly controlled studies of migraine behavioral therapy such as the study by Holroyd and colleagues included some treatment selection-participants could either choose cognitive stress management therapy or biofeedback for month 3 of the behavioral migraine management arm. (31) Moreover, as stated in our prior qualitative research, “In everyday practice…there is significant patient choice about whether or when to engage in a certain migraine treatment plan.” This meta-synthesis on migraine management also revealed that patients want treatment choice. (17)

Feedback received from the focus groups highlighted major barriers that patients face when they are enrolled in behavioral and mHealth studies, and the participants offered suggestions on how to improve upon the current study protocol. Several of the participants (4) expressed how excited they were to participate in this study when they were first approached. However, the majority of the patients who participated in these focus groups opted to withdraw or simply stopped using the RELAXaHEAD app on a consistent basis during the first three months of the trial.

Of all the feedback received, participants were most vocal about simplifying study requirements and providing more education on PMR. Evidence also indicates that a simplified and tailored medication regime correlates with better adherence. (33) Since there were a number of daily steps involved in this study, including entering information and completing PMR, it was difficult for patients to keep track of what they had and had not done, which is why a more streamlined approach is necessary. Additionally, during enrollment, the study team should walk through the app with the patients and explain the theory behind PMR and why it is important to complete both sessions on a daily basis. Some patients requested statistics on the impact of PMR among participants of past studies; therefore, results from a previous study providing behavioral therapy via a mobile app, which showed that patients receiving PMR exhibited a decreased number of headache days compared to the control group (34) would be important information to motivate further participants.

Strengths of the study were that all participants met ICHD-3 criteria. A prior meta-synthesis of 10 articles on migraine patients’ preferences for treatment revealed that only two of ten articles used the International Classification of Headache Disorders (ICHD) criteria. (17) Moreover, this study includes more detailed demographic and headache data than prior qualitative studies. In the meta-synthesis, only one study reported race, few studies appeared to capture data based on the headache treatment clinical practice guidelines, and only three studies specified the number of migraine/headache days of those participating in the study. In fact, one study had participants with only one headache day a month (35) and another had participants with only 1-2 days/month. (36) Only one had participants with 4 or more days a month which is typically the average number of headache days a month in which patients are on preventive medications. (37)

Limitations of the study were that the focus groups took place at one large academic urban medical center and thus the participants may not be representative of the national population. Despite the study being in a very diverse city, few participants in the focus groups were under-represented (50% were white,33.3% were Asian). Only 16.7% were black and other races. Due to modest sample size, results are not fully generalizable and we cannot evaluate differences by race and ethnicity. In addition, the modalities discussed (mHealth tools) and behavioral techniques were limited to just one smartphone application (RELAXaHEAD) and to one behavioral modality (PMR). Another potential limitation was that the focus groups were led by a headache neurologist who was also the principal investigator of the study. . The investment of the facilitator in the research, the unequal power relationship between the facilitator and participants and social desirability effects may bias the results. Finally, while we believe focus groups were good mechanisms to spark conversation and allowed participants to feed off of others’ answers to provide feedback, the methodology of focus groups may limit findings that a one-on-one interview uncovers and can lead to the loss of certain voices within the group. (38)

Future work should continue to involve people with migraine, through participatory action research, community-based participatory research, and the whole spectrum of community engagement. Future work should also try to include participants who are representative of those who experience migraine, including diverse racial/ethnic backgrounds sometimes under-represented in research. In addition, inclusion of participants with the common comorbidities of migraine, such as depression and anxiety, might improve generalizability of findings and broaden the targets of digital health solutions in persons with migraine; these approaches are also important because depression might affect reward learning and anxiety may affect working memory. (39)P Early findings suggest with the RELAXaHEAD app suggest that depression is associated with reduced adherence to both PMR and the diary while anxiety was positively associated adherence to both. (34)

Conclusion:

People with migraine are motivated to participate in mHealth and behavioral treatment studies to try new treatment modalities and/or further the knowledge in the field of migraine medicine. In general, they are receptive to non-pharmacologic treatments. They have different preferences for lengths of daily behavioral treatments, and they have differing opinions on how to best track their symptoms. They also want individualized methods to be contacted by study teams to meet their specific circumstances. There is a need for continued patient engagement/patient centered research as we continue to develop new treatments in the field of headache medicine so that we can learn the best ways patients can integrate various study interventions into their daily routines to optimize adherence and best test efficacy.

Table 3:

Participant experience during our studies

Themes and Subthemes	Representative Quote
Difficult to Conduct Follow Ups/Compliance Calls Via Phone
Did Not Answer Follow Up/Compliance Calls Because of Unknown Number	I think a lot of times also people don’t realize they were being called because it was a number they didn't recognize.
Voicemails Helpful in Returning Follow Up/Compliance Calls	I think you left messages. That’s why I called back.
Follow Up/Compliance Calls at Inopportune Times	Phone calls would always have to be rescheduled I would always be busy at the time.
Follow/Up Compliance Calls Caused Stress	And then I would get phone calls that I hadn’t recorded the information, and I found it very stressful.
Too Many Follow Up/Compliance Calls	I just felt the calls were incessant.
Confusion About Follow Up/Compliance Call Protocol	Moderator: So how it is structure, there were follow up calls for questions but then if you weren’t doing it then that was tracked and so you might get a phone call asking if there were any obstacles you know whatever, so those might have been those extra calls. You know you didn’t mention that.
Delay in Study Team Response Time to Questions	I did call once or twice and people always did try to follow up, but it might take a couple of days.
Should Add Relaxahead Phone Number in Contacts During Enrollment	I don’t know if you have your own number, but, then when someone gets set up, they set it up on their phone so that it says Relaxhead when you call.
Wants More Choices in Form of Follow Up/Compliance Contact
Prefers Follow/Compliance Emails	I find that emails are very, you know, helpful, as opposed to text or what have you, and I think for me, having a regular e-mail check-in would have helped.
Prefers Follow/Compliance Phone Calls	I think phone calls are better for me. If it is only an email or something, it’s too easy for me to skip, I get a lot of work emails, with a million coming in, like when I was looking for this, I had to go back and search headache research cause it was that many.
Prefers Follow/Up Compliance Texts	The reason why I think text messages would be better is because I’m constantly opening my text message app.
Prefers Option for Follow Up Visit	So I am thinking for me, my learning style, rather than a follow up phone call, I think I would have done with a follow up visit so that I could have said; I don’t understand how to enter the medicine, or that I could have said why can’t I just enter it once if I’m taking the same drugs every night and every morning and for me, the opportunity to have a follow up visit a week later to have to opportunity to say: I don’t know how to do this, I don’t know how to do this, I don’t know how to do that, so then I could have the support, of you know, figuring out how to use the app better. So, you know, more choices.
Prefers Option for Form of Follow/Compliance Contact	You know, if you’re able actually to give the option, of course, that would be the best of the best of all worlds.
Prefers Consistency in Follow Up/Compliance Contact	I certainly wouldn’t want multiple versions of like notifications in the app plus a text, plus an email or text plus a phone call.
Prefers Stricter Follow Up/Compliance Calls	Frankly, I think if there had been stricter follow up, it would be helped.
Wants Study to Be Less of a Time Commitment
Believes 6 Month Follow Up Is Too Long	6 months is kind of scary.
Prefers 3 Month Study Length	I think 3 months is probably a good amount of time, I think most people could do that.
Follow Up/Compliance Contact Should Be Once a Week	I think once a week would be fine. I don't recall if it was that.
Follow/Up Compliance Contact Should Be Once a Month	I think I was contacted once a month, I believe. It was three times during the 3-month study. And that was good timing.
Agrees with Current Study Setup
Agrees With 6 Month Study Length	Six months is maybe a good time frame that you would probably see…if you practice meditation or relaxation for 3 months, I would think you would see some benefits after 3 months and potentially 6 if you continue to do it.
Agrees that Follow Up/Compliance Contact Should Be After 3 Missed Days	I think 3 days sounds good. Like I imagine daily being a lot, cause if you just have like a super busy day, you might miss it, but it might not mean like forgot or are not interested anymore so maybe if you miss like 2 or 3 days that sounds right.
Appreciated Follow Up/Compliance Calls	I found the phone calls really helpful because I was able to get feedback on how to improve with recommendations.
Wants Opportunity to Interact with Other Migraine Sufferers
Prefers In-Person Support Group for Migraines	I think you could find a way to do both, yes it’s hard to do both, and it’s hard to get people to show up, but, at the end of the day, people who want to show up will and that can still benefit you and your study and getting people in with feedback face to face.
Wants Online Component of Support Group for Migraines	Something social network-y about the app. Some way of allowing people to interact with each other there.
Wants to Learn About Solutions from Other Migraine Sufferers	I like hearing other people’s stories; it is a little comforting to hear about other approaches or a shared experience.
Give Plenty of Time in Advance of Support Group Events	If we know ahead of time, we can make arrangements.
Appreciated In-Person Focus Group to Connect with Migraine Sufferers	I’m imagining if I just came to this focus group versus having everyone here and this is so much better.
Feels That Non-Migraine Sufferers Do Not Understand Severity of Pain	It happened to me when I was in the ER. I was like, please help me, it’s bad, but, if that person doesn’t live it, they can’t understand it.
Barriers That Inhibited Use of App
Migraines Inhibited Use of App
Headaches A Barrier to Study Adherence	I was in a bad way having so many headaches that having to complete another task put too much pressure on me.
Patience Limited Due to High Frequency of Migraines	I was having a lot of headaches at the time, so my patience was limited. And it just seemed to me that each step along the way I ran into an additional obstacle.
Disliked/Unable to Use Phone During Migraines	Like you could be talking to me and I wouldn’t even hear what you were sating, there were instances when I would have a migraine and I would be like I can’t even talk to you right now.
Non-Migraine Barriers Inhibited Use of App
Discontinued App Use Due to Interruption in Normal Schedule	I wasn’t going to take time out of my vacation, I could’ve been sitting on the beach doing it, I just wasn’t going to and then once I went back to work…I don’t have a good reason, I’d come home and do it for 5 minutes or 20 minutes but….
Discontinued App Use Due to Other Medical Problems	I have some medical problems I had to take care of, and I really wasn’t…as diligent as I should have been.
Discontinued App Use Due to Negligence	So, I did manage to use it for a while. I think, maybe two or three months. And then I got negligent.
Disliked Using Phone So Frequently	It was just being on the phone and putting the information in was a bit tedious.
Should Not Have Enrolled Due to Temperament	I think I wanted it, but I don’t think I have the temperament for this kind of activity.
Barrier to Study Adherence: Paranoid of Sharing Personal Data Online	Maybe I got a little, I don’t know, paranoid, that people were watching my phone.
Struggled with Tracking Information Daily
Only Wants to Deal with Pain Days Rather Than Do Something Every Day	I think I would rather do the work when I need to so I keep track of when I do have a migraine, I would write it down or do something to keep track and then I can report on that when I’m working with my doctor. But as far as doing something every single day, I would rather not do that. I would rather just deal with the pain days I think, than every single day.
Did Not Track Medication	Well I didn’t do any of that really, I think that I put the medications once.
Found Diary Entries Tedious	What started driving me crazy with the app was the journaling every day, just trying to keep track of it
Did Not Track Sleep Because It Was Not a Priority	I don’t think sleep is a big issue, like I know what all the doctors say to me, but I have already decided that sleep is not a factor for me, so I didn’t track that as well.
Already Knows Migraine Triggers so Diary Entries Not Helpful	I know most of my triggers, so I think that’s not necessarily something that felt particularly helpful.
Too Many Study Requirements	But the demands of managing it became just more than I could, you know, that I could deal with.
Uncertainty of App Features
Confused About In-App Surveys	I found the surveys, the words used were, “Are you feeling anxious, are you feeling nervous?” that they were so similar, I thought, how do I tell the difference?
Confused About How to Track Certain Features on App e.g. Sleep, Medication Side Effects, Headache Duration, Headache Intensity	I also found medicines a little more challenging, not quite sure why.
Ignored App Notifications Due to High Frequency of Multiple App Notifications	I get lots of notifications from different apps on my phones and I tend to generally swipe them all left and sort of ignore them.
App Reminders Inconsistent	And I did receive one or two reminders, but then, after that, I felt that I wasn't, you know keeping up with entering data and stuff, I didn't get reminded.
Unaware of Help Section or Availability of Data Report	And the other thing is that I wish you could see the big picture of some of the things that I reported on, or to see a big picture calendar or something that would have shown me a pull back on the data. Because I think all that we could see was one day at time.
Interested in Tracking Information Daily
What Information Patients Liked to Track
Diary Entries Helpful for Tracking Headaches	I liked the idea of tracking my headaches, I have always been told to track them, but I never really do.
Enjoys Tracking Medication/Medication Reminders	The other thing I really liked was, I was seeing a lot of doctors and on a lot of medications, so actually having something that was really integrated to keeping track if my medications everyday was really helpful.
Enjoys Tracking Sleep	I was able to keep track fairly well of my sleeping patterns.
Liked Tracking Menstrual Cycle	I have already identified that getting my period is definitely a big trigger, but I liked that aspect as well.
Used App to Track Migraine Triggers	I find that it made me aware of habits and patterns that I’ve sort of built into my schedule that I don’t want to change, even though I realize that contributes to the headaches.
Previously Used Other Methods to Track Information
Prefers App Diary Over Paper Diary	I liked having an app that you can use, instead of some paper diary.
Previously Used Phone Notes to Track Headaches	I also keep notes on my notes app on my phone about my headaches so I was doing double duty.
App Functionality Made It Difficult to Complete Study Requirements
App Drained Battery on Phone	I had the flipside of that issue where the app doesn't turn off so it would be something like, a couple of times, I would fall asleep using it and wouldn't wake up in the morning and miss my alarm because my phone was dead because it had been active the entire night.
App Froze When Opened	It freezes, so, I think only two times this happened. The app just didn't open. It didn't work.
Daily Diary Failed to Save	I was trying to put in the information for the current day, and it wouldn’t let me go back. I mean, it wouldn’t let me go to the current day, apparently, unless I had some information in the previous day.
Difficult to Correct Information in Daily Diary	Let’s say I entered my sleep data and then the next day I realize that I want to change it. So, when I want to go and change, for example, only the awake time, it changes everything. Like when I open it, all the data changes.
Unable to Access App Without WiFi	In order get in the app, I have to turn off my phone. Like, I go to the airplane mode and then access. But, if there is any like public WiFi interruption, then it just doesn't work.
Unable to Complete In-App Surveys	But then I think, when I wanted to complete the survey, I think I had some trouble with accessing it.
Poor Functionality of Medication Tab	But what would happen is that it would say; did you take your Clomipramine, and I would do in and I would have to select that one, and it would say something like, what milligrams did you take of it again, and I would have to say you know, 50 or whatever, and then it would say at what time did you take in and I would have to scroll through and put the exact time. And I recognize why all of those are important things to know, but it just ended up after a while, every single day putting in the exact same information.
Easy to Forget How to Navigate App	I haven’t used this part in so long, so I don’t really remember.
Did Not Recognize PMR Icon	In the beginning, I wasn't even doing the relaxation, because I didn't recognize what the icon was, the headphones, until I got a phone call to remind me to do the relaxation.
PMR Stopped Playing When Phone Locked	I don't know if it’s just my phone, but I would have to hold my lock screen because, whenever the lock screen would go on, my video would stop playing so I always had my hand on the lock screen while I was doing the app.
Need Time in Schedule to Complete Daily PMR
Free Schedule Promoted Daily PMR Use
Positive Influence of PMR Adherence: Off from School/Work	Moderator: So, what made it possible for you to do the progressive muscle relaxation when you did it? I’m a teacher, so I am off from school and work.
Positive Influence of PMR Adherence: Not Being Overwhelmed During Day	Moderator: And what’s made it possible for you to do the, or what made it possible, for you to do the progressive muscle relaxation when you did it? Time. Not being overwhelmed that day.
Endorses Importance of Making PMR Schedule
Creating Schedule Promoted PMR Use	I think it would really work much better if we build it into our daily schedule every day and earlier in the day. At least for me, I think if I could do that before I sort of, you know, before I go and do all my variable stuff during the day, I have a morning routine. And, if I could include that in the morning routine, I think that would help.
Self-Discipline Helped with PMR Adherence	I really wasn’t as diligent as I should have been.
Used Suggestions Given During Enrollment On When to Do PMR	That’s actually where I remember speaking with somebody specifically about the idea of, why don’t you do it right before or right after you brush your teeth? So that’s why that came up in my head. So that’s what I have been trying to do.
Barrier to PMR Adherence: Unable to Develop Daily Routine	Moderator: So, when were you doing it? I think all different times. Sometimes when I woke up, sometimes at night. Like I wasn’t super busy so, if I was doing something during the day, I’d probably do it at night, if I was doing something at night, I’d probably do it during the day.
Other Daily Commitments Inhibited PMR Use
Barrier to PMR Adherence: Exercise	I get delayed in doing my other stuff, you know, um my exercises and then I need to do this, I need to do that, and this is the one that doesn’t have the priority, unfortunately.
Barrier to PMR Adherence: Family	It’s like, you know, work is demanding, you have all these demands during the course of the day. Family to answer to, whether it is a husband, or fiancé, or elderly parent, or whatever is going on in your life, I think had I had more options, I would have stuck it out a little bit longer.
Barrier to PMR adherence: Work	Some days, I didn’t get to do it as I would have liked. Cause you’re supposed to do it like during the day at work, and I would get busy and not do it.
Only Able to Find Time/Space to Do PMR at Home	I have a shared office space so I am in an office with 3 or 2 other people. So I definitely just felt awkward, just uncomfortable doing that in front of them. Even though they are familiar with my headaches, but you just sit there quietly for a while and someone is going to poke their head up and say; what’s going on? So, I definitely only ever really tried to pursuit at home.
Difficult to Stick to Schedule to Complete Both PMRs	I tried to do it in the morning at a regular time in my apartment in a room separate from my husband or other people. So, I tried to do it, you know, as part of my morning routine and then part of the problem was that I would lose track of doing the second one as part of an evening routine.
Fell Asleep During PMR If Done at Night	Like sometimes, I was too exhausted and just fell asleep.
Being A Part of Research Study Promoted Daily PMR Use
Motivation to Adhere to PMR: Helping the Research	I felt I was being irresponsible, because I wanted to participate in this research, and I couldn’t keep it up. So, it made me feel guilty that I couldn’t do it.
Motivation to Adhere to PMR: Sense of Accomplishment	Maybe if there was more of a goal-oriented aspect of this, or if we were to have learned, up front, that research tells us that you don’t see a benefit from this, but if you stick it out for a hundred hours cumulatively, you’re going to see an improvement, statistically what might happen.
Enjoyed Doing Behavioral Therapy
PMR Had Positive Impact on Life
Found Breathing Techniques Helpful	Well, the breathing techniques were helpful to me because I was practicing yoga because of my rheumatoid arthritis pain, so I found the breathing helped. The breathing techniques helped, quite a bit with that.
PMR Calming	When I sleep and put the relaxation on, it brings me down, like calming, and, after some minutes, I am okay, so it works for me.
PMR Decreased Medication Frequency	I only need the meds every two and half months, three months maybe.
PMR Decreased Migraines	I had a very positive experience. My migraines really decreased
PMR Helped Determine Source of Headache	I was figuring out where the source of the headache was coming from, and this relaxation process definitely helped me do that.
PMR Helped Patient Focus in Morning	It helped me to focus in the morning.
Family Members Participate in PMR with Patient	My daughters listen to me every time I do the relaxation, and, at first, it was very hard, and they listen to me all the time. At first, it was very difficult for me to make them be quiet, they would be playing, but I would still be quiet doing it and, at some point, they would just lay down or sit beside me.
PMR The Preferred Treatment to Reduce Migraine Pain
Liked Audio Component of PMR	Moderator: It’s guided. Yeah, so that used to really help a bit. Hearing that person talk to you.
Prefers Non-Medication Therapy	I liked the idea of seeing what I could do without drugs to manage my headaches as much possible
Enjoy Doing PMR Exercises	I loved the exercise.
Did Not Enjoy Doing Behavioral Therapy
Most Difficult To Complete Long PMR
Difficult to Find Time for Long PMR	I just didn’t fully comprehend how long 20 minutes is going to feel like every day. It started getting really hard to set aside those 20 minutes each day.
Difficult to Sit Through Long PMR	The 15-minute relaxation video was hard to sit through, I would start dozing off. I have trouble meditating and focusing so that could just be me, but that 5 minutes was kind of like enough.
Found Long PMR Redundant	It was getting like really depressing and frustrating so maybe like a couple of different versions that people can choose from.
PMR Exercises Not Preferred Treatment to Reduce Migraine
Disliked Audio Component of PMR	I did remember thinking it would be helpful if the voice were different. Maybe not exactly the same every single time so that I’m not listening for specific cues.
Stressful to Be Forced to Relax	It becomes particularly stressful to be there trying to force yourself to relax
Prefers Drugs over Daily Therapy	Yeah, I would just say give me all of the drugs you got.
Lack of Motivation to Do PMR (No Reason Specified)	For whatever reason, I wasn’t motivated enough.
Not Convinced That PMR Will Improve Migraines
Barrier to PMR Adherence: No Immediate Benefit Seen	I didn’t see an immediate benefit, it wasn’t really a priority, so I think I stopped when I went on vacation.
Does Not Believe that PMR Will Work for Them	I think too much of me, is like; yeah right. I get that maybe it would work but, yeah sure, it works for somebody out there, but not me.
Played Audio Without Doing PMR to Adhere to Study Requirements	At some point I started putting the RelaxaHead, like I would come home but I would be starving, so I would put it on just so that whoever was checking the app would see that it was on and playing. I’d put it on, but I would be making dinner because I knew I would get a phone call saying; you didn’t do your app, you didn’t relax!
Stopped Doing PMR When Headaches Stopped
Medication or Other Therapy Decreased Headaches	I started this study on the exact same day that I started the Botox treatment. And the Botox was so effective after a certain period of time, I think like 3 weeks in, that I was just amazed. I started feeling like I didn’t have to rely as much on other abortive medications, or the actual headache study.
Barrier to PMR Adherence: Headaches Decreased/Improved	My headaches were getting less. I think if I was getting more headaches, I would be more diligent.
Headache Prevention Only a Priority When Headaches Daily/Severe	I think of all these things when I’m dying of a headache, but it’s not like front of mind, like I said I only did it a few weeks ago because I had nothing else to do, but like on a regular night, it’s not front of mind.
Must Make PMR a Priority to Adhere	I get delayed in doing my other stuff, you know, my exercises, and then I need to do this, I need to do that, and this is the one that doesn't have the priority, unfortunately. As of yet, I need to make it a priority.

Clinical Implications:

1. People with migraine are motivated to participate in mHealth and behavioral treatment studies.

2. People with migraine want greater flexibility and choice in study interventions and modes of follow-up.

3. There is a need for continued patient engagement/patient centered research as we continue to develop new treatments in the field of headache medicine.

4. There is a need to learn the best ways patients can integrate various study interventions into their daily routines to optimize adherence and best test efficacy.

Appendix

Appendix 1: RELAXaHEAD Migraine Study Focus Group Outline

Purpose:

The purpose of conducting focus groups of participants as part of this study is to obtain feedback on the program including format, location and delivery method.

Procedures:

1. The Research Assistant (RA) will contact participants after they have completed the last visit for the study and invite them to participate in a focus group. In accordance with IRB, a signed consent form for participation in the focus group and tape recording of the focus group will have been obtained in the initial consent process. Participating in the focus group is optional.

2. On the day of the focus group, the RA will facilitate the room set up as a private space with chairs, table, easel, markers and the tape recorder.

3. Dr. Mia Minen will thank the participants for attending. It is anticipated that each focus group will take about 45 minutes to an hour.

4. The RA will observe the focus group, take notes and assist the Focus Group Leader as required.

5. The Focus Group Leader will complete the focus group using the outline attached. Questions will be open ended, using a funnel approach that starts with general questions then refines to more specific questions regarding the program materials, content and delivery. Suggestions for improvement that may lead to increased use will be elicited. The focus group session will conclude with a general discussion on needs and preferences for intervention participation.

6. At the conclusion of the session, the focus group leader will return the tape recorder and other materials to the RA. The RA will ensure the tape recorder is secured in the Headache Research Office of Dr. Mia Minen. The RA will document either by recording comments or typing any notes about the conduct of the focus group.

FOCUS GROUP INTERVIEW GUIDE

1. What was your experience in the program –RELAXaHEAD?

   1. What did you like about the program?
   2. What would you like to change (either take away or add)?
   3. What could be done to improve the program?

2. How did you feel about the enrollment process?

3. What was it like to participate in the program?

   1. What were the benefits of the format?
   2. What were the drawbacks to this format?
4. What has made it possible or difficult for you to enter the headache diary app data?

   1. What kind of things made it hard <barriers>?
   2. What would make it easier <facilitators>?
5. What has made it possible for you to do the progressive muscle relaxation therapy?

   1. What kind of things made it hard <barriers>?
   2. What would make it easier <facilitators>?

6. How would you improve the app?

7. What did you think about the duration of time you were asked to spend doing the PMR on a daily basis? The frequency of the PMR (twice daily basis)?

8. What did you think about the total study duration-3 months to input daily and then another 3 months to see what people elect to do on their own?

9. If you were designing the program, how frequently and by what means would you prefer to be contacted to check in regarding complying with the daily diary entry and PMR practice?

10. Other feedback?