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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-14

Study Completion Date

2025-07-22

Brief Summary

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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.

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Detailed Description

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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

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Atrial Fibrillation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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People using YouControl-A-Fib app

Group Type EXPERIMENTAL

YouControl-A-Fib mHealth Application

Intervention Type DEVICE

Participants will use the app for 3 months, includes 1 month phone call with Health Coach

Interventions

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YouControl-A-Fib mHealth Application

Participants will use the app for 3 months, includes 1 month phone call with Health Coach

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Ability to understand and the willingness to sign a written informed consent document
* Willing to comply with all study procedures and be available for the duration of the study
* SmartPhone capable of pairing with a Fitbit Sense 2 and Fitbit App (Apple iOS 15 and higher or Android 10 or higher)
* Paroxysmal or persistent atrial fibrillation verified by 12-lead electrocardiogram (ECG) or other clinical grade monitoring
* body mass index (BMI) greater than 27

Exclusion Criteria

* History of permanent atrial fibrillation
* Left ventricular ejection fraction (LVEF) less than 45 percent
* Myocardial infarction, coronary artery bypass grafting, or valve surgery within the last 12 months
* Moderate to severe valve disease
* Inability to participate in a structured exercise program due to musculoskeletal disease
* Already participating in a structured exercise program or achieving guideline directed physical activity
* Planned surgery or procedure during the next three months that limit ability to engage in physical activity

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No