Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06638463
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-09
Brief Title:
My Health Coach App RCT
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Controlled Trial of the My Health Coach App for Adults with Fetal Alcohol
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
This trial involves a 2-arm randomized controlled trial Participants will be randomized 5050 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 andor 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
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None