NCT06575348

Evaluation of YouControl-AFib, a mHealth Application for Persons With Atrial Fibrillation

Implementation of the YouControl-AFib mHealth Application (Pilot Version) to Improve Physical Activity in Persons With Atrial Fibrillation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	YouControl-A-Fib mHealth Application	Participants will use the app for 3 months, includes 1 month phone call with Health Coach

Timeline

• Start date: 2024-10-14
• Primary completion: 2025-07-22
• Completion: 2025-07-22
• First posted: 2024-08-28
• Last updated: 2025-08-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study