RecruitingNot ApplicableNCT06500988

Mobile Health Technology-Enabled AFib Management

Patient Centered Mobile Health Technology-Enabled Atrial Fibrillation Management: Phase 2


Sponsor

Johns Hopkins University

Enrollment

248 participants

Start Date

Jun 3, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The overall objective of this proposal is to evaluate the effect on quality of life of a comprehensive digital atrial fibrillation (AFib) management tool that will empower patients to a) take an active role in learning about AFib management options, starting and adhering to evidence-based therapies and lifestyle changes and b) to guide the patients during AFib episodes which are associated with anxiety and impairment in quality of life. Researchers plan to evaluate the effectiveness of this novel digital toolkit in improving quality of life and decreasing AFib burden in a randomized clinical trial (RCT). A pilot study assessing feasibility and retention of the intervention was previously conducted (NCT05400837)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses a mobile health app and wearable device to help manage atrial fibrillation (an irregular heart rhythm) in people who also have a higher body weight. The program includes lifestyle coaching and heart rhythm monitoring through technology. **You may be eligible if...** - You are 18 or older - You have been diagnosed with paroxysmal atrial fibrillation (episodes lasting less than 7 days) or persistent atrial fibrillation (lasting 7 or more days) - Your BMI (body mass index) is 27 or higher **You may NOT be eligible if...** - Your atrial fibrillation is permanent (a decision has been made not to try to restore normal heart rhythm) - You have severe valve disease or significant mitral valve narrowing - You have had prior heart surgery or have an implanted heart device (such as a pacemaker) - You have had a cardiac arrest - Your heart pumping function (ejection fraction) is 35% or below - Your life expectancy is less than 1 year - You do not speak English - Your doctor has said exercise is unsafe for you Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTCorrie Virtual Atrial Fibrillation Management Program

Intervention aims to implement a comprehensive digital atrial fibrilation guideline-recommended toolkit


Locations(2)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Johns Hopkins Outpatient Center

Baltimore, Maryland, United States

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NCT06500988


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