Table 2.
Study characteristics
| Digital health tool category | Author (reference), year (country/countries) | Tool name (operating system), manufacturer/vendor/developer | Description of tool | Study design | Participants: sample size, (age range or SD), females and males | Headache type (migraine, cluster, tension or other) | Primary outcome |
|---|---|---|---|---|---|---|---|
| Diary keeping | Allena et al. [32], 2012 (Italy) | Tool name unknown, (Windows CE version 3.0 operating system), ATC Service, Pavia, Italy | Palm device with diary and personal digital assistant | Parallel-group randomized clinical trial with usual care control to assess the effect of a doctor visit preparatory website on migraine management as intervention (myexpertdoctor.com) on doctor-patient communication | 85 participants (age unknown), 68 females and 17 males | Other: medication-overuse headache | Participants found the electronic diary easy to understand and use. Compliance was higher compared to traditional paper version |
| Bandarian-Balooch et al. [33], 2017 (Australia) |
diary.com (iOS, Android, Windows and website version using HTML) |
Electronic diary | Parallel-group randomized controlled trial to examine differences in reliability, validity, and headache outcomes between e-diaries versus paper diaries | 181 participants (18–55 year of age), 146 females and 35 males | Migraine, tension-type and other: migraine with aura and comorbid tension-type headache, migraine without aura and comorbid tension-type headache, probable migraine or tension-type headache | E-diaries and short-paper diaries resulted in less missing data and errors than long-paper diaries. Also, e-diaries and short-paper diaries were less heavy and less difficult to use than long-paper diaries | |
| Barmettler et al. [34], 2015 (USA) | REDCap (Safari, Internet Explorer, Chrome) | Record and track temporal pattern of migraine | Observational prospective cohort study to assess pain onset, location and distribution in patients with migraine | 36 participants (20–55 years of age), 28 females and 8 males | Migraine | The electronic tool for collecting data on the migraine headache patterns was able to capture patterns of pain distribution. It may also be used to determine changes in patterns of pain distribution | |
| Berengueres and Cadiou [35], 2016 (Singapore) | Migraine Buddy (Android, iOS), Healint | Electronic diary to monitor migraine episodes | Observational retrospective cohort study to assess triggers, symptoms and treatment in patients with migraine/Poor paper | 83.000 participants (18–65 years of age), 72.920 females and 10.080 males | Migraine | Main triggers of migraine were stress, lack of sleep, and anxiety. Main symptoms of migraine were light sensitivity, noise, and neck pain. Main reliefs of migraine were sleep, dark room rest, and stay indoors (drugs not included) | |
| Cronin et al. [36], 2018 (Italy) | HeadApp!© | Mobile application for self-reporting | Observational retrospective cohort study for algorithm construction/Non-clinical | 1194 participants, age and gender unknown | Migraine | Self-reported data from mobile applications can be used to construct algorithms for identifying migraine criteria and medication, such as headache classification, usage and effectiveness | |
| Filipi and Khairat [37], 2013 (USA) | Tool name unknown (web-based) | Web-based diary. Full-size website and mobile website | (Web) Development of a e-diary/This paper does not report on a study | Unknown | Other: chronic headache | A full-size website and mobile website were designed and implemented, by which users can input data about their headaches | |
| Giffin et al. [38], 2003 (UK) | Philips Nino Model 312 (Microsoft Windows CE), Philips Electronics N.V., New York, NY/Provenda Biometrics, Inc., Blue Bell, PA (customization) | Device with diary questions to monitor symptoms of attacks | Observational prospective (multi-center) cohort study to assess non-headache symptoms before, during and after migraine attacks in patients with migraine | 97 participants (24–69 years of age), 92 females and 5 males | Migraine | Main premonitory symptoms were fatigue, having difficulty concentrating, and stiff neck | |
| Giffin et al. [39], 2016 (UK) | Tool name unknown | Electronic diary with daily alarming including symptom related questions | Observational prospective cohort study to examine migraine postdrome symptoms | 120 participants, age and gender unknown | Migraine | Postdrome symptoms are common characteristics of migraine attacks for people who report non-headache symptoms | |
| Goldberg et al. [40], 2007 (USA) | Nino handheld device, Provenda Biometrics (Blue Bell, PA) | Mobile device with daily self-assessment (including alarming) | Observational prospective cohort study to evaluate an electronic diary tool to evaluate migraine during menstrual period and relationship of headache to menstrual symptoms | 20 participants (21–47 years of age), 20 females | Migraine and other: headaches and premenstrual symptoms | The electronic diary led to many abnormal endings of sessions. It was not clear whether this was because of the subject or device error | |
| Heyer and Rose [19], 2015 (USA) | Tool name unknown | Electronic diary | Observational prospective (longitudinal) cohort study to assess compliance with a diary protocol in patients with migraine | 52 participants (10–18 years of age), 38 females and 14 males | Migraine | Compliance was highest on days when abortive headache medicine was used or in the first 2 weeks of the diary. Compliance was lowest on evenings | |
| Houle et al. [41], 2017 (USA) | Palm Pilot with Pendragon forms software and REDCap software (iOS and web-based), Pendragon and REDCap | Diary assessing headache activity, characteristics and medication use | Observational prospective (longitudinal) cohort study to develop a forecasting model for headache | 95 participants (age unknown), 86 females and 9 males | Migraine and other: episodic migraine | Participants had headache attacks on 38.5% of all days. Through a prediction model, headache attacks can be predicted for different individuals | |
| Huguet et al. [42], 2015 (Canada) | myWireless Headache Intervention diary (myWHI diary) (iOS) | Electronic diary via mobile phone | Summative usability evaluation to assess usability principles of an e-diary/Psychometirc validation of diary items/this article reports on various studies at the same time | 108 participants (14–28 years of age), 93 females and 15 males | Migraine and tension-type | Mobile diary was perceived as useful, easy to learn, and efficient to use | |
| Kikuchi et al. [43], 2012 (Japan) | Ruputer ECOLOG, Seiko Instruments Inc | Electronic diary | Observational prospective cohort study to assess headache intensity and exacerbations in patients with tension-type headache | 31 participants (20–60 year of age), 22 females and 9 males | Tension-type | Tension-type headaches have significant diurnal variation, with the highest intensity in the late afternoon and the lowest intensity in the morning | |
| Kikuchi et al. [44], 2015 (Japan) | Ruputer ECOLOG (W-PS-DOS version 1.16), Seiko Instruments Inc., Tokyo, Japan | Electronic diary via watch-type computer | Observational prospective cohort study to asses pain intensity and pain interference in women with migraine and obesity | 23 participants (20–59 years of age), 18 females and 5 males | Tension-type | Subsequent increase in headache exacerbation within 3 h was correlated to momentary psychological stress. This correlation was not found for the individual mean of psychological stress | |
| Kroon Van Diest et al. [45], 2016 (USA) | iMigraine Application 1.1 AND MEMS6® TrackCap (iOS), the Divisions of Behavioral Medicine and Clinical Psychology and Bioinformatics at CCHMC AND AARDEX Corporation | Medication adherence monitor and personal electronic diary device | Observational prospective cohort study to collect data on medication and lifestyle recommendation adherence in adolescents with migraine | 56 participants (11–17 years of age), 40 females and 16 males | Migraine | Electronic monitoring resulted in higher rates of medication adherences compared to self-reported rates. This was higher for patients taking medication once a day compared to patients taking medication twice a day | |
| Moloney et al. [46], 2009 (USA) | Tool name unknown, (Javascript and Cold Fusion) | P&P headache diary and health history questionnaire. Electronic diary via personal digital assistant | Observational prospective cohort study to collect data via ecological momentary assessment in patients with tension-type headache to relate psychological stress to TTH exacerbations | 77 participants (18–55 years of age), 77 females | Migraine | Personal digital assistant diaries resulted in higher data accuracy and feasibility than paper and pencil diaries | |
| Palermo et al. [47], 2004 (USA) | Hewlett Packard Jornada 548 (Windows CE version 3.0) | Electronic diary on a handheld computer | Parallel-group randomized controlled trial to assess impact on compliance, accuracy, and acceptability in e-diary versus p-diary | 60 participants (8–16 years of age), 42 females and 18 males | Other: headache (or juvenile idiopathic arthritis) | Compliance was higher for children with e-diaries compared to p-diaries. Acceptability and ease-of-use were both equally high | |
| Park et al. [48], 2016 (Taiwan) | Tool name unknown, M2Community Co., Ltd | Smartphone Headache Diary Application (SHD). Monitor details concerning headache trigger factors and characteristics | Observational prospective cohort study to assess migraine triggers in episodic migraineurs | 62 participants (19–55 years of age), 51 females and 11 males | Migraine | Smartphone Headache Diary Applications is complete in estimating episodic migraine triggers. Main triggers of migraine are stress, tiredness, and sleep deprivation. Risks of migraine can be increased by traveling, hormones, noise, alcohol, overeating, and stress | |
| Park et al., 2018 [49] (Korea) | Tool name unknown, M2Community Co., Ltd | Smartphone Headache Diary Application (SHD). Monitor headache trigger factors and characteristics | Observational prospective cohort study to assess circadian variations in the clinical presentation of migraine through a smartphone headache diary | 82 participants (adults), 69 females and 13 males | Migraine | Headaches mostly occurred in the morning. Most headaches were non-migraine. In the morning, headache characteristics were most common | |
| Seng et al. [50], 2018 (USA) | N1-Headache® (Curelator Headache®) (iOS), Curelator Inc | Mobile headache diary (via physician, paid or free) | Observational prospective (longitudinal) cohort study to assess factors related to adherence with mobile headache diaries | 1561 participants (18–80 year of age), 1376 females and 336 males | Migraine | Headache people have difficulties with adherence to electronic headache diaries. Lower adherence is associated with higher daily anxiety, younger age and free availability of the app | |
| Sorbi et al. [51], 2007 (The Netherlands) | PalmOne Treo 600 (Linux, supported by the software components Apache Web Server, Java, PostgresSQL, and Tomcat, and data encrypting is authorized by SSL certification), Palm Inc, Sunnyvale, CA, USA | Personal digital assistant for home-based cognitive-behavioral treatment. Focused on preventing attacks, identifying attacks and supportive preventive healthy behavior | Formative usability evaluation (pilot) study on online digital assistance in migraine/non-clinical | 5 participants (24–52 years of age), 5 females | Migraine | Online digital assistance was acceptable, in terms of user-friendliness, absence of burden, and perceived support. Also, it was feasible, in terms of acceptable data loss and good participant compliance | |
| Tassorelli et al. [52] 2017 (Italy) | The Comoestas tool, COMOESTAS Project | Electronic diary including an alerting system and patient-doctor communication | Parallel-group randomized controlled trial to assess headache outcomes between Comoestas group (electronic monitoring) and the classic group (paper headache diary) | 663 participants (18–65 years of age), 521 females and 142 males | Other: medication-overuse headache | Use of the electronic tool reduced medication overuse and improved adherence to treatment | |
| Thomas et al. [53], 2016 (USA) | Tool name unknown | Ecological momentary assessment based on smartphone | Observational prospective cohort study to asses pain intensity and pain interference in women with migraine and obesity | 116 participants (18–50 year of age), 116 females | Migraine | Pain intensity appeared to be a determiner of pain interference on migraine headache days. Allodynia, pain catastrophizing and headache management self-efficacy are moderators of pain intensity | |
| Vo et al. [54], 2018 | Migraine Buddy© | Smartphone application for self-reporting of migraine patterns, characteristics and mechanisms | Observational retrospective cohort study to assess burdens of migraine using a smartphone application | 3900 participants (18–74 year of age), 2545 females and 336 males | Migraine | Migraine attacks strongly influence patients' health-related quality of life, work and personal well-being | |
| Behavioral or therapeutical intervention | Huguet et al. [55], 2014 (Canada) | Tool name unknown (iOS) | iPhone interface for psychosocial treatment program | Qualitative formative usability study by means of a focus group of with prospective end users to identify user needs and preferences for ICT-mediated psychosocial support for headache self-care/Non-clinical | 25 participants (14–28 year of age), 19 females and 6 males | Migraine and tension-type | According to participants, the smartphone pain diary should be used daily, must be easily accessible, should be customizable and interactive. Also, participants want to communicate with other headache patients and experts |
| Kleiboer et al. [56], 2009 (The Netherlands) | PalmOne Treo 600 (Linux, supported by the software components Apache Web Server, Java, PostgresSQL, and Tomcat, and data encrypting is authorized by SSL certification), Palm Inc, Sunnyvale, CA, USA | Personal digital assistant (PDA) for cognitive-behavioral treatment. Home-based training of behavioral attack prevention and identifying attacks | Summative usability evaluation to assess acceptance of online self-management training for migraine by means of a survey to new patients and expert patients/non-clinical | 44 participants (25–63 years of age), gender unknown | Migraine | Feasibility and acceptability were positively influenced by online digital assistance as part of behavioral training. However, online digital assistance as part of behavioral training did not result in more physical improvements compared to behavioral training only | |
| Law et al. [57], 2015 (USA) | Tool name unknown (Web-MAP) | Online cognitive-behavioral treatment for families. Web-Based Management of Adolescent Pain | Parallel-group randomized controlled trial to determine feasibility and effectiveness of internet cognitive-behavioral intervention adjunctive to specialized headache treatment versus specialized headache treatment alone | 83 participants (11–17 years of age), 68 females and 15 males | Migraine and tension-type | For both Internet cognitive-behavioral group and specialized headache treatment group, a reduction in headache days was reported. However, there was no significant difference between those groups | |
| Sorbi et al. [14], 2015 (The Netherlands) | MyMigraine/ID MigraineTM SCL-90 R | Training in relaxation and cognitive-behavioral techniques. Eight lessons with homework | Parallel-group randomized controlled trial to examine effectiveness of online behavioral training in self-management versus waitlist control for migraine patients | 368 participants (18–65 years of age), 314 females and 54 males | Migraine | Self-efficacy, internal and external control in migraine management, and migraine-specific quality of life only improved in online behavioral training and not in the waitlist control group | |
| Sorbi et al. [58], 2017 (The Netherlands) | MyMigraine/ID MigraineTM SCL-90 R | Training in relaxation and cognitive-behavioral techniques. Eight lessons with homework | Parallel-group randomized controlled trial to examine benefits of online behavioral training between receiving this directly or after 10 months of watchful training | 468 participants (18–65 years of age), 406 females and 62 males | Migraine | Online behavioral therapy positively changed migraine frequency compared to 'watchful waiting' | |
| Sorbi and Van der Vaart [59], 2010 (The Netherlands) | MyMigraine | Self-management via internet training tool to prevent attacks | Summative usability evaluation to assess usability and feasibility principles and psychometrical soundness of an electronic headache diary | 10 participants (33–68 years of age), 8 females and 2 males | Migraine | Study 1 included ratings of clarity, instructiveness, importance and ease of an Internet training aid, which were all rated positively. Study 2 included ratings of the web application, digital support, and web adaption of the protocol, which were also all rated positively | |
| Diary keeping AND behavioral or therapeutical intervention | Devineni and Blanchard [60], 2005 (USA) | Tool name unknown (commercial Windows NT server with a Web address assigned to the University at Albany domain) | Database-backed study website. Internet technology including behavioral interventions and headache diary | Parallel-group randomized controlled trial to examine differences in pain symptoms and functional impairment in Internet-delivered treatment versus symptom monitoring alone | 86 participants (adults), 71 females and 15 males | Migraine and tension-type | Internet-based treatment decreased headache activity, general headache symptoms, and headache-related disability compared to monitoring waitlist control. It was also more time saving |
| Minen et al. [61], 2018 (USA) | RELAXaHEAD Application | Headache diary and program for progressive muscle relaxation | Formative usability evaluation of an app by thinking aloud protocol/Non-clinical | 10 participants (20–74 years of age), 8 females and 2 males | Other: headache | Daily diary was reported as easy to use and understand, relevant for tracking headaches and relevant to personal interest and attention. The progressive muscle relaxation matched their interest and attention, but also improved their stress and low mood | |
| Other: teleconsultation | Müller et al. [62], 2016 (Norway) | Tool name unknown, other: teleconsultation (Cisco C40 integrator package, Cisco C40 Integrator Multisite, Cisco Precision HD 1080p 12xcamera, NEC X551s 55″ LED monitor, Audio-Technica ceiling microphones and JBL LSR2325P active speakers, Integrator Package C40 dual display option, and Cisco touch-control device for C Series), Cisco | Telemedicine consultations via video conferencing system | Parallel-group randomized controlled trial to determine the differences in acceptability, feasibility, and costs between specialist telemedicine visits versus traditional specialist visits for headache patients | 402 participants (16–65 years of age), gender unknown | Migraine, tension-type, other: trigeminal autonomic cephalalgia, new daily persistent headache, primary stabbing headache, medication-overuse headache | Telemedicine for non-acute headaches is another option to traditional consultations, which is accepted, feasible, time-saving, and cost-saving |
| Müller et al. [63], 2017 (Norway) | Cisco C40 integrator package/Cisco EX60 (Cisco), Cisco | Telemedicine consultations | Parallel-group randomized controlled trial to determine long-term treatment efficacy and safety via telemedicine consultations versus traditional consultations | 402 participants (16–65 years of age), 301 females and 101 males | Other: non-acute, and less likely secondary | No differences were found between telemedicine and traditional consultations in long-term treatment efficacy and safety | |
| Müller et al. [64], 2018 (Norway) | Tool name unknown | Telemedicine consultation via two-way audio and video | Parallel-group randomized controlled trial to determine patients satisfaction of telemedicine consultations and traditional consultations | 402 participants (16–65 years of age), 301 females and 101 males | Other: non-acute headache | Long-term satisfaction was higher for telemedicine patients than for traditional consultations | |
| Qubty et al. [65], 2018 (USA) | Cisco WebEx application (Cisco), Cisco | Telemedicine consultations via laptop, desktop, tablet, or mobile phone | Summative usability evaluation by means of a survey to end users/non-clinical | 51 participants (4–20 years of age), 93 females and 15 males | Other: headache | Patients and families are convinced that telemedicine is more convenient, causes less disruption of daily routine and is more cost-effective than clinic visit | |
| Other: patient portal | Sciamanna et al. [66], 2006 (USA) | https://www.myexpertdoctor.com | Web-based computer program with patient-doctor communication. Patient receives personalized feedback, which can include questions the patient should consider, explanations, or referral to further information | Parallel-group randomized controlled trial to determine effects of using a migraine-specific doctor-patient communications website. Differences between using the website before (intervention) or after a visit (control) were assessed | 50 participants (age unknown), 46 females and 4 males | Migraine | Web-based computer program (website) may positively influence doctor-patient communications, in terms of improved care and quality of life |
| Other: training tool for specialists | Raieli et al. [67], 2018 (Italy) | Tool name unknown, Janssen | Training tool for specialists, including different information sources, discussion page and WhatsApp group | Observational prospective cohort time-series (longitudinally—4 months) study to collect headache data via online diary to assess feasibility and acceptance properties of online diaries/non-clinical | 67 participants, age and gender unknown | Migraine | Subscriptions were increased with about 80%, which shows there is an increased appreciation of social networks. Activity has not significantly increased |
| Other: telemonitoring (medication adherence) | Ramsey et al. [68], 2018 (USA) | MedaCheck app (www. medacheck.com) (Android, iOS) | Mobile phone reminder system for adherence | A single case clinical (or AB – Baseline-Intervention) study in which a series of measurements is taken repeatedly for individuals with different levels of intervention. Participant in study acts as his own control. Aim is to assess an app with reminder on adherence of preventive treatment in AYA with migraine | 35 participants (13–21 years of age), 27 females and 8 males | Migraine | Mobile phone application adherence rates are significantly higher than self-reported app-based adherence rates. Also, acceptability and convenience were rated as high |