Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: May 18, 2020
Date Accepted: Jul 26, 2020
A Mobile Health Messaging Intervention for Adherence in AYAs with Chronic Kidney Disease: Results of a Pilot RCT and Stakeholder Interviews
ABSTRACT
Background:
Up to 1/3 of adolescents and young adults (AYAs) with chronic kidney disease (CKD) exhibit suboptimal rates of adherence to renal-protective antihypertensive medications. Mobile health (mHealth) interventions may promote higher adherence to these medicines in AYAs with CKD but empirical research is needed to inform best practices for applying these modalities.
Objective:
This multi-phase investigation developed and tested a theoretically-informed mHealth messaging intervention (based on the COM-B model for generating behavior change) to improve antihypertensive medication adherence in AYAs with CKD in a pilot randomized controlled trial. Qualitative data on user experiences were also obtained.
Methods:
In Phase 1, the intervention messages (involved sending a Reminder+COM-B message) were developed via stakeholder engagement of AYAs with CKD and pediatric nephrologists. In Phase 2, the Reminder+COM-B message intervention was tested against a Reminder-only message active control condition in an 8-week pilot randomized controlled trial. The primary outcome was daily electronically-monitored antihypertensive medication adherence and secondary outcomes included pre-post AYA surveys of adherence self-efficacy, adherence barriers, outcome expectancies for taking medicine, and motivation for and importance of taking medicine. In Phase 3, qualitative interviews about user experiences were conducted with AYAs in the Reminder+COM-B message intervention group.
Results:
Following Phase 1, 34 AYAs with CKD (Mean age=16.59 years, 41% female, 38% African American/Black, 35% hypertension diagnosis; Reminder+COM-B message intervention message group=18 AYAs, Reminder-only message active control group=16 AYAs) completed the Phase 2 pilot randomized controlled trial. All AYAs in the Reminder+COM-B message intervention group completed a Phase 3 qualitative interview. Overall, study procedures were feasible to implement and 0/18 AYAs in the Reminder+COM-B message intervention group reported the messages reduced their desire to take medicine. Pre-randomization, there were no significant group differences in the rate of change in daily adherence over time. However, post-randomization, there was a significant group by time interaction (B=.01, P=.04) in which daily adherence decreased significantly over time in the Reminder-only active control group but remained stable in the Reminder+COM-B message intervention group. There were no significant differences by group in pre-post changes in AYAs’ survey responses. Qualitative interviews revealed AYAs’ perceptions of how the Reminder+COM-B message intervention changed adherence behavior and highlighted several areas for improving the intervention (e.g., adapt messaging timing, intensity, and content to match daily adherence, send praise when medicine is taken).
Conclusions:
The Reminder+COM-B message intervention has potential to promote daily medication adherence in AYAs with CKD beyond simple reminders. Further research is needed to determine the Reminder+COM-B message intervention’s mechanisms of adherence behavior change and to incorporate qualitative AYA feedback into a modified version of this intervention to enhance its efficacy. Clinical Trial: ClinicalTrials.gov NCT03651596
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