Mobile health toolkit for managing atrial fibrillation
Patient Centered Mobile Health Technology-Enabled Atrial Fibrillation Management: Phase 2
This trial will test whether a mobile digital toolkit (Corrie) helps adults with paroxysmal or persistent atrial fibrillation improve quality of life and reduce AFib episodes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 248 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 2 sites (Baltimore, Maryland and 1 other locations) |
| Trial ID | NCT06500988 on ClinicalTrials.gov |
What this trial studies
This randomized clinical trial will compare a comprehensive digital AFib management toolkit (Corrie Virtual Atrial Fibrillation Management Program) to usual care in adults with paroxysmal or persistent atrial fibrillation and BMI ≥27. The intervention combines remote patient monitoring, patient education about management options, guidance during AFib episodes, and support for lifestyle and risk-factor modification delivered via mobile devices. Primary outcomes include change in AF-specific quality of life and AF burden, with secondary outcomes such as adherence to evidence-based therapies and feasibility metrics. A prior pilot (NCT05400837) assessed feasibility and retention of the intervention.
Who should consider this trial
Good fit: Adults aged 18 or older with paroxysmal or persistent atrial fibrillation, BMI ≥27, who are English-speaking and able to use a smartphone, and who do not have permanent AFib, severe valvular disease, implanted cardiac devices, or an LVEF ≤35%.
Not a fit: Patients with permanent AFib, severe valvular disease, prior cardiac surgery or implanted cardiac devices, very low LVEF, life expectancy under one year, non–English speakers, or those unable/unwilling to use mobile technology are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the toolkit could improve day-to-day quality of life, reduce symptomatic AF episodes, and increase adherence to medications and lifestyle changes.
How similar studies have performed: A prior pilot of this same toolkit showed feasibility and retention, and other digital and remote-monitoring programs for AFib have shown promise for engagement and symptom tracking though large randomized clinical benefit data remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged 18 or older at time of consent 2. Diagnosis of paroxysmal (Afib lasting less than 7 days) or persistent (7 days or longer) atrial fibrillation 3. BMI (Body Mass Index) ≥ 27.0 Exclusion Criteria: 1. Permanent Afib (decision has been made not to attempt sinus rhythm) 2. Severe valvular disease 3. Moderate mitral valve stenosis 4. Prior cardiac surgery 5. Presence of implanted cardiac device 6. History of cardiac arrest 7. Left ventricular ejection fraction (LVEF) ≤ 35% 8. Life expectancy \< 1 year 9. Non-English speaking 10. Treating clinician deems unsafe for exercise 11. Any other reason that makes patient unsuitable for study at the discretion of the PI
Where this trial is running
Baltimore, Maryland and 1 other locations
- Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States (Recruiting)
- Johns Hopkins Outpatient Center — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Nino Isakadze, MD — Johns Hopkins University
- Study coordinator: Nino Isakadze
- Email: nisakad1@jhmi.edu
- Phone: 410-955-5999
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.