JMIR Publications

ABSTRACT

Background:

Compliance rates for mobile health (mHealth) studies that involve intensive study designs are highly variable. Factors such as the number of assessments (included ecological momentary assessments [EMAs]), as well as study duration, and study compensation are all factors that contribute to this variability. Understanding these different factors and their impact on study engagement are critical to the success of mHealth interventions.

Objective:

The primary objective of this report was to analyze the overall and component-specific completion and compliance rates for an intensive six-month mobile health intervention (CareQOL app) designed to promote self-awareness and self-care among care partners of individuals with traumatic brain injury (TBI).

Methods:

This randomized controlled trial consisted of 1) a baseline assessment of several care partner patient-reported outcome measures (PROs) that assessed health-related quality of life (HRQOL) and proxy measures of the functional/mental status of the person with TBI; 2) a 6-month home monitoring period that included three daily ecological momentary assessment (EMA) questions, monthly PRO surveys assessing 12 HRQOL domains, and continuous activity and sleep monitoring using a Fitbit®; and 3) two follow-up PRO surveys assessing care partner HRQOL at 3 and 6 months post-home monitoring. Care partners were randomized to one of two study arms: self-monitoring alone (n=128) or self-monitoring plus self-care push notifications (n=126). All participants had access to a self-monitoring dashboard (CareQOL app) that included graphical displays of the daily survey scores as well as daily steps and sleep data from the Fitbit®.

Results:

Overall compliance for the different aspects of the study was high. On average, the full-sample daily EMA PROs completion rate was 84%, Fitbit®-based step count compliance was 90%, and Fitbit®-based sleep duration compliance was 75%; there was no difference between the study arms for daily EMA PROs and Fitbit® compliance rates. Completion rates for monthly and follow-up PRO surveys were even higher, with average end-of-month completion rates ranging from 94% to 98%, and follow-up completion rates of 92% for both time points. Again, these rates did not differ by study arm. The Fitbit®-based activity and sleep compliance rates were moderately correlated (r = 0.65); whereas correlations between Fitbit®-based compliance and EMA PRO completion were less robust (r = 0.38 between steps and PROs and r = 0.29 between sleep and PROs).

Conclusions:

The compliance rates for this intensive study design are consistent, but at the high end, with what has been reported previously in the literature for studies with shorter time durations. We anticipate the high compliance rates observed in the current study likely are due to several study-specific design elements that were employed to encourage study engagement. Clinical Trial: ClinicalTrial.gov NCT04570930; https://clinicaltrials.gov/ct2/show/NCT04570930