Mobile health toolkit for managing atrial fibrillation
Official title: Patient Centered Mobile Health Technology-Enabled Atrial Fibrillation Management: Phase 2
Run by Johns Hopkins University · NCT06500988 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 248 (estimated) |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 2 sites (Baltimore, Maryland and 1 other locations) |
| Status | Recruiting |
| Started | June 3, 2025 |
| Main results expected | June 2028 |
| Study ends | June 2028 |
| Registry record updated | April 20, 2026 |
| Trial ID | NCT06500988 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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%.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.