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mHealth Application

Mobile Health App for Atrial Fibrillation

N/A
Recruiting
Led By Matthew M Kalscheur, MD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Paroxysmal or persistent atrial fibrillation verified by 12-lead electrocardiogram (ECG) or other clinical grade monitoring
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test a mobile health app called YouControl-AFib to help people with atrial fibrillation improve their heart health. The study will gather feedback on the app's design for future

Who is the study for?
This trial is for people with atrial fibrillation who can legally consent, have a BMI over 27, and are willing to follow the study rules. They must own a smartphone compatible with Fitbit Sense 2 and App (iOS 15+/Android 10+), and their condition must be confirmed by ECG or similar monitoring.
What is being tested?
The 'YouControl-AFib' mHealth application is being tested to see if it can help improve heart health in those with atrial fibrillation. The study will gather user feedback on the app and collect early data for future research design.
What are the potential side effects?
Since this trial involves using an mHealth application rather than medication, traditional side effects are not expected. However, participants may experience issues related to app usability or challenges adhering to the app's recommendations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with atrial fibrillation through an ECG or similar test.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mobile App Rating Scale Scores
Secondary study objectives
Change in Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT) Score
Change in Atrial Fibrillation Knowledge Assessment Tool (AFKAT) Score
Change in Atrial Fibrillation Symptom Severity (AFSS) Score
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: People using YouControl-A-Fib appExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,226 Previous Clinical Trials
3,168,614 Total Patients Enrolled
National Center for Advancing Translational Sciences (NCATS)NIH
359 Previous Clinical Trials
411,198 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
70 Patients Enrolled for Atrial Fibrillation
Matthew M Kalscheur, MDPrincipal InvestigatorUW School of Medicine and Public Health
~40 spots leftby Jun 2025
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