Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06575348
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
Evaluation of YouControl-AFib a mHealth Application for Persons With Atrial Fibrillation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Implementation of the YouControl-AFib mHealth Application Pilot Version to Improve Physical Activity in Persons With Atrial Fibrillation
Status:
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:
This study is being done to establish the feasibility of performing a clinical trial using a mHealth application named YouControl-AFib designed to improve the cardiovascular health of persons with atrial fibrillation The study will obtain feedback on the app design to inform future versions and will collect preliminary data to support proof-of-concept and potential effect sizes for future trial design
Detailed Description:
Primary Objective
To effectively recruit participants for a clinical trial and obtain user feedback on the mHealth app using the Mobile App Rating Scale and focus group sessions
Secondary Objectives
To evaluate the impact of the YouControl-AFib mHealth app pilot version 3 months of use on physical activity in persons with atrial fibrillation
To obtain several additional functional and disease specific endpoints that will help establish possible effect sizes to be evaluated more formally in subsequent versions of the mHealth application
To obtain user feedback on the mHealth app using the Mobile App Rating Scale and focus group sessions
To effectively recruit participants for a clinical trial and obtain user feedback on the mHealth app using the Mobile App Rating Scale and focus group sessions
Secondary Objectives
To evaluate the impact of the YouControl-AFib mHealth app pilot version 3 months of use on physical activity in persons with atrial fibrillation
To obtain several additional functional and disease specific endpoints that will help establish possible effect sizes to be evaluated more formally in subsequent versions of the mHealth application
To obtain user feedback on the mHealth app using the Mobile App Rating Scale and focus group sessions
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