Ecological Momentary Assessment and Intervention Clinical Trial
Official title:
Mobile Behavioral Ecological Momentary Assessment and Intervention in Rakai, Uganda: A Pilot Study
| Verified date | July 2020 |
| Source | Johns Hopkins University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Ecological Momentary Assessment and Intervention (EMAI) is an emerging technique for
gathering richer and more relevant data through repeated, longitudinal sampling of
participants in their natural setting in order to deliver real-time interventions. The main
study objective is to conduct a pilot EMAI study in Rakai, Uganda. Secondary objectives are
to assess processes, facilitators, and barriers to EMAI. The study will compare behaviors
between participants randomized to receive intervention messages and those not receiving
messages. To assess EMAI validity and relevance, EMAI-collected behavioral data will be
compared with traditional questionnaire-collected data.
After recruitment, participants will be given a smartphone with an application that will
collect geospatial coordinates and ask behavioral assessment questions on topics including
diet/alcohol, smoking, and sexual behaviors. Participants will have training on the phone and
application, demonstrating proficiency with the EMAI interface prior to study start.
Days 1-30, Baseline Behaviors: Participants will complete assessment questions to establish
baseline behaviors. This will include twice-daily and weekly behavioral report prompts and
participant-initiated event-contingent behavioral reports. After the initial 30 day period,
participants will return to the study office to complete a short questionnaire and to be
randomized to the second phase of follow-up.
Days 31-90, Randomized Evaluation: Participants will be randomized in a 1:1 ratio to either
continue assessment questions only (control arm) or to also begin receiving intervention
messages (intervention arm) in response to reported behaviors. Messages will encourage
positive behaviors and suggest alternatives to negative behaviors (e.g. "Eating a mixed diet
(meats and vegetables) is a healthy way to go."). At 90 days of follow-up, participants will
return to the study office to complete a brief questionnaire on behaviors and smartphone
experiences.
Study hypotheses are as follows: EMAI can be successfully implemented in Uganda, and
participants receiving intervention messaging will have improved self-reported health
behaviors compared to controls; EMAI will be feasible and acceptable by this population; and,
EMAI-collected data will correlate with traditional questionnaire-collected data.
Outcomes will be assessed using descriptive statistics, multivariate regression and analysis
of themes in patient EMAI experience and acceptability.
| Status | Completed |
| Enrollment | 58 |
| Est. completion date | May 31, 2017 |
| Est. primary completion date | May 31, 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 18 years or older - literate - current Rakai Community Cohort Study participant We will purposely recruit a sample that has a broad range of participant characteristics in our study to optimize diversity of responses and increase study generalizability. Specific variables for which we will target sampling include: gender (~50% female), age (at least 20% among age groups 18-25, 26-35, >50), and occupation (at least 20% traders and farmers). Exclusion Criteria: - Participants without a listed phone number in the Rakai Community Cohort Study |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Johns Hopkins University | Rakai Health Sciences Program |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in health behavior according to EMAI self-report | change in the proportion of days when participant reports 'yes' to behavior over total days behavior measured, comparing baseline to follow-up in self-reported: alcohol consumption, fruit and vegetable consumption; cigarette smoking, and sex with a non-longterm or non-marital partner | Daily, comparing baseline (days 1-30) to follow up (days 31-90), up to a total 90 days |