Mobile Health App for Atrial Fibrillation

Overseen By Anna Longergan, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Permanent atrial fibrillation, LVEF < 45%, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile health app called YouControl-AFib, designed to help people with atrial fibrillation (a type of irregular heartbeat) improve their heart health. Researchers seek feedback on the app's design and aim to gather initial data to assess its potential effectiveness in future studies. Individuals with paroxysmal or persistent atrial fibrillation (episodes of irregular heartbeat verified by a heart test), a BMI over 27, and a compatible smartphone may qualify. As an unphased trial, this study offers a unique opportunity to contribute to the development of innovative health technology.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It would be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this mobile health app is safe for people with atrial fibrillation?

Research shows that YouControl-AFib, a mobile health app, helps people with atrial fibrillation manage their condition. As an app, YouControl-AFib requires no medication or medical procedures, which likely makes it very safe. It focuses on helping users improve their quality of life through self-management. So far, no harmful side effects have been reported from using the app. The study aims to gather feedback on the app's functionality and potential improvements for future users. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional medications and procedures for atrial fibrillation, which often involve drugs like beta-blockers or procedures like catheter ablation, the YouControl-AFib app offers a novel approach through digital health technology. This mobile app empowers patients by providing real-time monitoring and personalized feedback, potentially improving adherence to treatment and lifestyle modifications. Researchers are excited because this app could make managing atrial fibrillation more accessible and engaging, offering a convenient, non-invasive alternative that fits seamlessly into everyday life.

What evidence suggests that the YouControl-AFib app is effective for atrial fibrillation?

Research has shown that the YouControl-AFib app, which participants in this trial will use, might help people with atrial fibrillation, characterized by irregular heartbeats, by improving their quality of life. Studies have used special surveys to assess how well people feel and how much they know about their condition after using the app. Early results suggest that users may feel more informed and in control of their heart health. Input from patients guided the app's design, ensuring it is easy to use and relevant to their needs. ^{1 2 3 6 7}

Who Is on the Research Team?

Matthew M Kalscheur, MD

Principal Investigator

UW School of Medicine and Public Health

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can understand and am willing to sign the consent form.

I am willing and able to follow all study rules and attend all appointments.

I have been diagnosed with atrial fibrillation through an ECG or similar test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the YouControl-AFib mHealth app to improve physical activity and provide feedback on the app design

3 months

Baseline and 3-month follow-up visits

Follow-up

Participants are monitored for changes in quality of life, physical activity, and other health metrics after using the app

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• YouControl-AFib

Trial Overview

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.

How Is the Trial Designed?

Group I: People using YouControl-A-Fib app Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Published Research Related to This Trial

In a study of 105 adults with atrial fibrillation using the Alivecor® KardiaMobile ECG monitor, frequent usage was linked to the presence of premature atrial contractions (PACs), indicating that patients with more noticeable symptoms are more likely to engage with digital health tools.

Factors such as lower symptom burden and less concern about treatment were associated with moderate usage of the device, suggesting that understanding patient experiences and concerns can help improve the adoption of digital health technologies in managing atrial fibrillation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac symptom burden and arrhythmia recurrence drives digital health use: results from the iHEART randomized controlled trial. Masterson Creber, RM., Reading Turchioe, M., Biviano, A., et al.[2022]

The myAlgos mHealth system was rated as easy to use by both physicians (PSSUQ score of 2.52) and patients (MAUQ score of 79.9%), indicating good usability for managing atrial fibrillation.

In a study involving 80 patients with paroxysmal atrial fibrillation, those using the full version of myAlgos experienced a significant improvement in quality of life (+2.63%) compared to control users (-1.63%), demonstrating its efficacy in enhancing patient well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The usability and effect of an mHealth disease management platform on the quality of life of patients with paroxysmal atrial fibrillation - The emPOWERD-AF study. Lazaridis, C., Bakogiannis, C., Mouselimis, D., et al.[2022]

The MENARI Plus app demonstrated high sensitivity (84%) and specificity (87.9%) for detecting atrial fibrillation (AF) in a study of 1385 high-risk patients, making it a reliable screening tool.

Self-pulse assessment showed moderate sensitivity (73.1%) and specificity (68.3%), indicating that while it can help identify AF, MENARI Plus provides a more accurate assessment compared to traditional ECG methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validity of MENARI plus (self-pulse assessment and clinical scoring) mobile apps for detecting atrial fibrillation in high-risk population. Fadlan, MR., Rizal, A., Satrijo, B., et al.[2023]

A review of 555 atrial fibrillation self-management apps found only five that met the criteria for inclusion, indicating a significant lack of high-quality options for patients.

The included apps generally offered basic functions like educational content and medication tracking but were rated as poor to acceptable in quality, lacked intuitive design, and none had undergone clinical trials, highlighting the urgent need for better, clinically validated mHealth interventions for atrial fibrillation management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atrial fibrillation self-management: a mobile telephone app scoping review and content analysis. Pearsons, A., Hanson, CL., Gallagher, R., et al.[2022]

In the eBRAVE-AF trial involving 5,551 participants, digital screening using a smartphone app significantly increased the detection rate of treatment-relevant atrial fibrillation (AF) compared to usual care, with odds ratios of 2.12 and 2.75 in the first and second phases, respectively.

This study suggests that digital screening for AF is not only effective but also has the potential for widespread use due to its accessibility on smartphones, although further research is needed to determine if it improves treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone-based screening for atrial fibrillation: a pragmatic randomized clinical trial. Rizas, KD., Freyer, L., Sappler, N., et al.[2023]

A mobile app designed for older adults to screen for atrial fibrillation (AF) showed a high compliance rate of 82% during a 2-week home-based monitoring protocol.

The app was well-accepted by users, who felt confident in its integration with their electronic health records, indicating it could be a practical tool for self-monitoring AF and improving communication with healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Implementation and Acceptability of a Mobile Application for Screening for Atrial Fibrillation at Home. Ashburner, JM., Lee, PR., Rivet, CM., et al.[2021]

The CATCH ME Consortium has developed two smartphone apps aimed at improving the management of atrial fibrillation (AF) by enhancing patient education and communication with healthcare professionals.

These apps, available for free on major platforms, are designed to integrate the latest ESC Practice Guidelines into clinical practice, potentially leading to better patient outcomes through increased engagement and optimized treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

European Society of Cardiology smartphone and tablet applications for patients with atrial fibrillation and their health care providers. Kotecha, D., Chua, WWL., Fabritz, L., et al.[2023]

Over half of the 206 atrial fibrillation (AF) apps evaluated were excluded for being unrelated or inaccessible, highlighting a significant issue with the availability of relevant resources for patients.

Most apps aimed at non-healthcare professionals had low scientific validation (only 15.8% on Apple and 13.0% on Google Play) and were written at a high readability level (average grade 12.1), which may hinder understanding for users with limited health literacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile health applications for atrial fibrillation: A readability and quality assessment. Ayyaswami, V., Padmanabhan, DL., Crihalmeanu, T., et al.[2022]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06575348

Evaluation of YouControl-AFib, a mHealth Application for ...

This study is being done to establish the feasibility of performing a clinical trial using a mHealth application named YouControl-AFib designed to improve ...

2.

heartrhythmopen.com

heartrhythmopen.com/article/S2666-5018(25)00336-8/pdf

ID:&nbsp;4342339 DEVELOPMENT AND QUALITATIVE ...

Outcomes included the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) and Atrial Fibrillation Knowledge Assessment Tool (AFKAT), measured at baseline and ...

3.

heartrhythmopen.com

heartrhythmopen.com/article/S2666-5018(25)00336-8/fulltext

ID: 4342339 DEVELOPMENT AND QUALITATIVE ...

YouControl-AFib is a DHI developed using the IDEAS (integrate, design, assess and share) framework. We gathered insights from a patient advisory council, ...

4.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT06575348/evaluation-of-youcontrol-afib-a-mhealth-application-for-persons-with-atrial-fibrillation

Evaluation of YouControl-AFib, a mHealth Application for ...

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 ...

5.

withpower.com

withpower.com/trial/phase-atrial-fibrillation-7-2024-dd77a

Mobile Health App for Atrial Fibrillation · Info for Participants

YouControl-AFib is unique because it is a mobile health app designed to help patients manage atrial fibrillation by improving their quality of life through self ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11328870/

Atrial fibrillation burden: a new outcome predictor and ...

This review describes the relation between AF burden and outcomes and potential effects of AF burden reduction.

7.

malacards.org

malacards.org/card/atrial_fibrillation

Atrial Fibrillation

Integrated disease information for Atrial Fibrillation including associated genes, mutations, phenotypes, pathways, drugs, and more - integrated from 78 ...