My Health Coach App RCT

University of Rochester

Status: Enrolling

Conditions: Fetal Alcohol Spectrum Disorders

Treatments: Behavioral: My Health Coach app

Study type: Interventional

Funder types: Other

Identifiers

NCT06638463

STUDY00009709

Details and patient eligibility

About

The goal of this clinical trial is to learn if the My Health Coach app helps adults with fetal alcohol spectrum disorders (FASD). The main questions it aims to answer are:

Does the My Health Coach app improve the quality of life of adults with FASD? Does the My Health Coach app help adults with FASD manage their day to day life?

All participants will be asked to complete 3 sets of surveys: 1) at the study start, 2) at 6 weeks, and 3) at 12 weeks. Half of the participants will be given the app at the study start to use. The other half of participants will get the app after the 12 week surveys are complete.

Researchers will compare survey results from people who receive the app right away to those who are in the waitlist group to see if there are changes in quality of life or day to day functioning.

Full description

This trial involves a 2-arm randomized controlled trial. Participants will be randomized (50:50 allocation) into the (1) My Health Coach group, or the (2) Wait-list Control group. The My Health Coach app is designed to support the quality of life of adults with FASD by providing tools to help with self-management, advocacy, health literacy, use of supports, and engagement in meaningful activities.

This study is designed to: (1) evaluate the efficacy of the My Health Coach app with adults with FASD, (2) test whether changes in competence, autonomy, and/or relatedness mediate intervention outcomes on reported quality of life, and (3) identify app usage patterns that relate to greater outcome improvement. Primary outcomes include perceived well-being, the degree to which basic psychological needs of competence, autonomy, and relatedness are met, and readiness for self-management. We are also interested in participants' perceptions of app quality and patterns of app usage.

All participants will complete the study assessment battery measuring these outcomes at baseline (T1), 6 weeks (T2), and 12 weeks (T3). Wait-list participants will receive the app after T3.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult 18 years or older
• have a fetal alcohol spectrum disorder (FASD) or history of prenatal alcohol exposure
• have sufficient fluency in written English
• own a smartphone

Exclusion criteria

• participated in the past feasibility trial of the My Health Coach app

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

200 participants in 2 patient groups

My Health Coach App Group

Experimental group

Description:

The My Health Coach group receives the My Health Coach app at study start. The My Health Coach app is a self-directed mobile health intervention for adults with FASD. It is grounded in self-determination theory and integrates well-established behavior change strategies. It has a cloud-based infrastructure and uses a just-in-time adaptive intervention design and a simple and engaging chatbot interface. It provides adults just the right type and amount of support, when they are most receptive.

Treatment:

Behavioral: My Health Coach app

Waitlist Control Group

No Intervention group

Description:

The Waitlist Control Group gets access to the My Health Coach app after all the study survey timepoints are complete at 12 weeks.