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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment YouControl-AFib for atrial fibrillation?

The emPOWERD-AF study showed that a similar mobile health app, myAlgos, improved the quality of life for patients with atrial fibrillation by making it easier for them to manage their condition. ^{1 2 3 4 5}

Is the Mobile Health App for Atrial Fibrillation safe for use in humans?

The available research does not provide specific safety data for the Mobile Health App for Atrial Fibrillation, but it highlights usability and acceptability in patients, suggesting it is generally well-received and easy to use. However, no clinical trials have specifically evaluated its safety. ^{2 3 6 7 8}

How is the YouControl-AFib treatment different from other atrial fibrillation treatments?

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-care and education, unlike traditional treatments that primarily focus on medication or procedures. ^{1 2 3 4 5}

Research Team

Matthew M Kalscheur, MD

Principal Investigator

UW School of Medicine and Public Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Cardiac symptom burden and arrhythmia recurrence drives digital health use: results from the iHEART randomized controlled trial. [2022]

2. England 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. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Atrial fibrillation self-management: a mobile telephone app scoping review and content analysis. [2022]

4. England pubmed.ncbi.nlm.nih.gov

European Society of Cardiology smartphone and tablet applications for patients with atrial fibrillation and their health care providers. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Mobile health applications for atrial fibrillation: A readability and quality assessment. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Smartphone-based screening for atrial fibrillation: a pragmatic randomized clinical trial. [2023]

7. Japan 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. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

The Implementation and Acceptability of a Mobile Application for Screening for Atrial Fibrillation at Home. [2021]