Momentary Factors and Study Characteristics Associated With Participant Burden and Protocol Adherence: Ecological...

Ecological momentary assessment (EMA) has become a popular mobile health study design to understand the lived experiences of dynamic environments. The numerous study design choices available to EMA researchers, however, may quickly increase participant burden and could affect overall adherence, which could limit the usability of the collected data.

This study quantifies what study design, participant attributes, and momentary factors may affect self-reported burden and adherence.

The EMA from the Phase 1 Family Matters Study (n=150 adult Black, Hmong, Latino or Latina, Native American, Somali, and White caregivers; n=1392 observation days) was examined to understand how participant self-reported survey burden was related to both design and momentary antecedents of adherence. The daily burden was measured by the question "Overall, how difficult was it for you to fill out the surveys today?" on a 5-item Likert scale (0=not at all and 4=extremely). Daily protocol adherence was defined as completing at least 2 signal-contingent surveys, 1 event-contingent survey, and 1 end-of-day survey each. Stress and mood were measured earlier in the day, sociodemographic and psychosocial characteristics were reported using a comprehensive cross-sectional survey, and EMA timestamps for weekends and weekdays were used to parameterize time-series models to evaluate prospective correlates of end-of-day study burden.

The burden was low at 1.2 (SD 1.14) indicating "a little" burden on average. Participants with elevated previous 30-day chronic stress levels (mean burden difference: 0.8; P=.04), 1 in 5 more immigrant households (P=.02), and the language primarily spoken in the home (P=.04; 3 in 20 more non-English-speaking households) were found to be population attributes of elevated moderate-high burden. Current and 1-day lagged nonadherence were correlated with elevated 0.39 and 0.36 burdens, respectively (P=.001), and the association decayed by the second day (β=0.08; P=.47). Unit increases in momentary antecedents, including daily depressed mood (P=.002) and across-day change in stress (P=.008), were positively associated with 0.15 and 0.07 higher end-of-day burdens after controlling for current-day adherence.

The 8-day EMA implementation appeared to capture momentary sources of stress and depressed mood without substantial burden to a racially or ethnically diverse and immigrant or refugee sample of parents. Attention to sociodemographic attributes (eg, EMA in the primary language of the caregiver) was important for minimizing participant burden and improving data quality. Momentary stress and depressed mood were strong determinants of participant-experienced EMA burden and may affect adherence to mobile health study protocols. There were no strong indicators of EMA design attributes that created a persistent burden for caregivers. EMA stands to be an important observational design to address dynamic public health challenges related to human-environment interactions when the design is carefully tailored to the study population and to study research objectives.