Feasibility and Acceptability of a REDCap-Embedded HIPAA-compliant Text Messaging Application to Track Medication Adherence in Adolescents with Lupus

Abstract

Background/Objective:

Despite advances in clinical care and treatment options, adolescents with lupus continue to experience adverse health outcomes. Poor adherence to medication regimens is a major contributor to these negative outcomes. The utility of short message service (SMS) in tracking barriers to adherence prospectively, remains untested for adolescents with lupus. Our objectives were (1) feasibility of incorporating a HIPAA-compliant SMS text messaging application into REDCap and (2) acceptability of using SMS text messaging to track barriers to medication adherence in adolescents with lupus

Methods:

A 12-week pilot cohort study of adolescents with SLE per the 1997 revised American College of Rheumatology. A REDCap-embedded HIPAA-compliant text messaging application was used to send bi-weekly messages with survey link to track medication adherence. Measures were completed. Descriptive statistics were used to summarize demographics, medical, and acceptability data. Response to text messages and survey completion rates were reported as a measure of feasibility.

Results:

Most eligible adolescents approached agreed to participate (N=17, 71% enrollment rate). Cellphone ownership rate among adolescents eligible for participation was 92%. Nine subjects responded to all text messages sent (53% response and completion rate). Eleven subjects (65%) responded to two-thirds of the text messages. Overall, 77% of enrolled subjects completed at least half of the surveys sent. Reminders to complete surveys were sent to 30 % of enrolled adolescents.

Conclusion:

This study shows that embedding a HIPAA-compliant SMS text message application in REDCap is feasible and can be used to engage adolescents with chronic conditions in monitoring between clinic visits.

Introduction

Despite advances in clinical care and treatment options, adolescents with lupus continue to experience higher morbidity and mortality. Compared to their age- and gender-matched healthy counterparts, the mortality rate is alarming.¹ Adolescents with lupus also demonstrate disease-related mortality rates nine times those of adults with lupus.² Poor adherence to medication regimens is a major contributor to these negative health outcomes.³

Decision-making about adherence is a complex, dynamic process influenced by each individual’s own goals, values, knowledge, skills, and social factors.⁴ Because these factors may influence daily medication adherence differentially, it is valuable to understand daily barriers when designing interventions. Thus far, research studies involving adolescents with lupus have emphasized cross-sectional representations of barriers to adherence, often based on recalled information by the adolescents or their caregivers.^{5, 6} Although these cross-sectional studies give insight into the prevalence of non-adherence, they fail to capture the daily decisions influencing whether an adolescent takes their medication as prescribed. In addition, they are limited by recall bias, because the reported information is based on past behavior and decisions. Frequent and prospective assessments of barriers address this limitation.

The utility of short message service (SMS), the text messaging service available on mobile phones, in tracking barriers to adherence prospectively remains untested for adolescents with lupus. SMS text messaging is an important first step in assessing barriers as they occur because adolescents, young adults, and older adults already use technology in their daily lives (i.e., for communicating, confirming appointments, banking, or completing questionnaires).⁷ Furthermore, pediatric and adult literature show that repeated measures of barriers to adherence are necessary as individual barriers vary as patients age and disease status evolves.⁸

Consistent with the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) goal of “studying…social, and behavioral interactions as they relate to disease…outcomes of rheumatic diseases”⁹, determining the feasibility of a Health Insurance Portability and Accountability Act (HIPAA)-compliant text messaging application to track barriers to medication adherence will address the urgent need to comprehensively examine the barriers that may drive adolescents with lupus to be non-adherent. Thus, in this manuscript we describe the (1) feasibility of incorporating a HIPAA-compliant SMS text messaging application into REDCap and (2) acceptability of using SMS text messaging to track barriers to medication adherence in adolescents with lupus. We postulate that incorporating a HIPAA-compliant SMS text messaging application into REDCap is feasible, and will be acceptable to a majority of subjects within the study.

Methods

2.1. Subjects and recruitment

Study subjects included adolescents with lupus ages 11–19 years. Subjects were recruited over a 12-week period during routine pediatric rheumatology clinic visits at a Southeastern children’s hospital. Inclusion criteria were: 1) met diagnosis of SLE per the 1997 revised American College of Rheumatology (ACR) criteria¹⁰, 2) patient between ages 11 and 19 years, 3) English-speaking, 4) on daily medications, and 5) ownership or access to a cellular phone and ability to receive text messages and access a link. Patients with significant developmental delays or cognitive dysfunction (i.e., autism spectrum disorder) were excluded. Study staff approached eligible subjects at regularly scheduled clinic visits. All questions were addressed and written informed consent and assent was obtained.

2.2. Procedure

Study procedures were approved by the hospital’s Institutional Review Board. For Phase 1 of this pilot study, adolescents completed one questionnaire and a demographics form. If the patient was <18 years of age, the demographics form was completed by a caregiver.

2.3. Measures

Demographics.

A demographic information questionnaire completed by young adults and caregivers included patient’s age, ethnicity, gender, and co-morbid disorders.

Electronic medical chart review.

Information regarding lupus diagnosis, SLE Disease Activity Index (SLEDAI, treatment regimen, and medical and psychosocial co-morbidities were abstracted from the electronic medical record (EMR). The SLEDAI is completed through a standardized process where all key elements are documented by every provider within the division at the time of patient visit. The total SLEDAI score is then calculated in a flowsheet in the EMR after lab data are entered. SLEDAI scores from clinic visits preceding enrollment were reported for this study.

2.4. Outcome Measures

Feasibility and acceptability

This was assessed using: 1) enrollment and retention rates, 2) proportion of completed SMS text message surveys, and 3) acceptability of the twice weekly text messages as characterized by a written questionnaire.

Feasibility and acceptability questionnaire

This study-specific survey assessed feasibility and acceptability of the HIPAA-compliant SMS text messages. The survey was modified from a feasibility questionnaire containing 12-items including information on ease of use, psychological benefits, and new knowledge about lupus, using a Likert-scale with scores ranging from 1 to 5.¹¹ A score of 4 and 5 indicated agreement or strong agreement with intervention features (e.g., ease responding to text messages). Similar questionnaires have been used by adherence researchers and provide critical information on ways to improve adherence interventions.¹¹

Tracking Barriers to Adherence Outcomes

All adolescent subjects were asked to provide a cellular telephone number at enrollment. For this pilot study, a HIPAA-compliant institutional Twilio account, a cloud communications platform used in research to contact subjects, was used to generate a local mobile number that was then incorporated into REDCap via the REDCap Project Setup page. Then the REDCap project was configured to send survey invitation link via text messaging. Once clicked, the link opened a brief survey with the initial screening question “Have you missed any doses of your medication?” If “yes” was selected for a missed dose, a second question, “What makes it hard to take your medicine?” was populated. Answer options included the top three most reported barriers (i.e., forgetfulness, taste, side effects) ⁶ and a 4^th option for free text. If “no” was selected, then “What makes it easy to take your medicine?” was populated. The answer option for this question was in free text format. Figure 1 shows text messaging steps, while supplemental figure lists steps for Twilio-REDCap integration. Reminders were also programed to be sent twice if no response is recorded in the REDCap system. Fee to use the institutional HIPAA-compliant Twilio account was $125 (US dollars) per month for 5000 text messages, sent or received. For non-pilot studies, institutional cost was $250 (US dollars) per month. Cost for non-HIPAA compliant text messages are significantly lower.

Figure 1.

Study Text Message Steps

2.5. Statistical analysis

Descriptive statistics were used to summarize demographics, medical characteristics, and acceptability data. Response to text messages and survey completion rates were reported as a measure of feasibility.

Results

Table 1 summarizes demographic and disease characteristics for all subjects. We approached twenty-four eligible adolescents and seventeen agreed to participate (enrollment rate of 71%). Seven were deemed ineligible for varied reasons including non-English-speaking caregiver (2), cognitive dysfunction (1), did not meet age criteria (1), lack of a cellphone (2), and refused to participate (1). There were no differences between those who agreed to participate and subject who refused. Cellphone ownership rate among adolescents eligible for participation was 92%.

Table 1.

Demographic and disease characteristics of adolescent participants

Demographic	Adolescent (N = 17)
Female, N, (%)	13 (76)
Age (mean, SD)	16 (1.5)
Race, N, (%)
Black	7 (41)
White	2 (12)
Latinx	5 (29)
Asian	3 (18)
More than one race	0
Other	0
Disease
Average No of Medications, N, (range)	6 (2–9)
SLEDAI, Mean, (range)	2.7 (0–8)
Co-Morbidities, N, (%)	12 (70)
Lupus Nephritis, N, (%)	14 (82)
CNS Lupus, N, (%)	1 (5)

We found that incorporating Twilio into REDCap and utilizing this platform to send survey links via text messages was feasible. Nine subjects responded to all text messages sent by completing REDCap based survey (53% response and completion rate). Eleven subjects (65%) responded to text messages sent by completing two-thirds of the survey distributed over 12 weeks. Further, 77% of enrolled subjects completed at least half of the surveys sent. Reminders to complete surveys were sent to only 30 % of enrolled adolescents.

Table 2 summarizes feasibility results. Ninety-four percent of subjects deemed text message link as easy to use. One subject did not return for post-study feasibility assessment. A third of the subjects desired weekly text messages over twice a week. More than two-thirds (75%) of subjects wanted to continue to receive text messages at study completion.

Table 2.

Feasibility and Acceptability of HIPPA-Compliant SMS Text Messaging mHealth Technology

SMS Text Messaging	Adolescents (N = 16)
	N (%)
Text message link was easy to use	15 (94)
Link did not have glitches	14 (88)
Survey questions were easy to answer	15 (94)
Text messages made me more interested in my lupus	8 (50)
I became bored with the text messages and survey questions	4 (25)
I wish the text messages were once a week	5 (31)
I wish the text messages were more than 2 times a week	0
I will like to continue to receive text messages in the future	12 (75)

Discussion

In this pilot study, we assessed the feasibility of incorporating a HIPAA-Compliant SMS text messaging application into REDCap and acceptability of using SMS messaging to track barriers to medication adherence in adolescents with lupus. We evaluated the feasibility using three criteria: enrollment rate, survey completion rate, and ease of use. Most of the eligible adolescents approached agreed to participate. Only one person refused to participate after meeting eligibility criteria. Cellphone ownership rate among adolescents eligible for participation was 92%. Our findings are consistent with the literature documenting the acceptability of SMS text message interventions among adolescents with chronic conditions.^{7, 12} Adherence with our SMS text message protocol was high, with most subjects responding to at least 75% of surveys sent during the monitoring period.

SMS text messaging is a promising tool that is increasingly being used in patient-engaged research across many conditions.^{7, 13, 14} Although utility in research studies involving chronic conditions is increasing, few studies have explored its application among adolescents living with lupus.^{13, 15} Our study shows that adolescents with lupus are comfortable communicating through SMS text messages, and that their caregivers are comfortable with research staff engaging with their adolescents via this technology. Next steps for this pilot study include analyzing results from the adherence surveys and comparing results to those from validated adolescent and caregiver adherence assessment measures. Further, assessing the caregiver-adolescent relationship dynamic as it may relate to adherence is important.

Despite the valuable findings from this feasibility study, there were some limitations. The small sample size of this pilot study limits the generalizability of our findings to the broader population of adolescents diagnosed with lupus. Additionally, non-English speaking families were excluded from this study which also limits generalizability. Another limitation is that two adolescents did not own cellphones and the study did not make provisions to address this barrier. Future studies, with adequate funding, can address some of these barriers.

This study shows that embedding a HIPAA-compliant SMS text message application in REDCap is feasible and can be used to engage adolescents with chronic conditions in surveys or monitoring between clinic visits.

Supplementary Material

Supplemental Figure 1

Supplemental Figure. Steps for Twilio-REDCap Integration