Actively Recruiting
Mobile Health Technology-Enabled AFib Management
Led by Johns Hopkins University · Updated on 2026-04-20
248
Participants Needed
2
Research Sites
156 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
P
Pharmaceutical Research & Manufacturers Of America Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Mobile Health Technology-Enabled AFib Management
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 or older at time of consent
- Diagnosis of paroxysmal (AFib lasting less than 7 days) or persistent (7 days or longer) atrial fibrillation
- Body Mass Index (BMI) 27.0 or higher
You will not qualify if you...
- Permanent AFib with decision not to attempt sinus rhythm restoration
- Severe valvular disease
- Moderate mitral valve stenosis
- Prior cardiac surgery
- Presence of implanted cardiac device
- History of cardiac arrest
- Left ventricular ejection fraction (LVEF) 35% or less
- Life expectancy less than 1 year
- Non-English speaking
- Treating clinician deems unsafe for exercise
- Any other reason deemed unsuitable by the principal investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Actively Recruiting
2
Johns Hopkins Outpatient Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
N
Nino Isakadze
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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