Mobile Health Technology-Enabled AFib Management
Recruiting · NCT06500988 · Interventional (participants receive a specific treatment) · Lead sponsor: Johns Hopkins University
View the official record on ClinicalTrials.gov →Interventions studied
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)
Who can take part
Inclusion criteria
- 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
- BMI (Body Mass Index) ≥ 27.0
Exclusion criteria
- Permanent Afib (decision has been made not to attempt sinus rhythm)
- 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%
- Life expectancy \< 1 year
- Non-English speaking
- Treating clinician deems unsafe for exercise
- Any other reason that makes patient unsuitable for study at the discretion of the PI
Where it is running
2 locations listed across 1 US state.
- Johns Hopkins Bayview Medical Center - Baltimore, Maryland, United States
- Johns Hopkins Outpatient Center - Baltimore, Maryland, United States