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Recruiting Not applicable NCT06500988

Mobile Health Technology-Enabled AFib Management

No applicable phase (e.g. observational)
Conditions: Atrial Fibrillation Behavior

Sponsor: Johns Hopkins University

trial.available_in: БГ
Overview
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 participate
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
Interventions
Corrie Virtual Atrial Fibrillation Management Program
COMBINATION_PRODUCT
Locations 2
United States (2)
Johns Hopkins Bayview Medical Center
Baltimore , Maryland
Johns Hopkins Outpatient Center
Baltimore , Maryland
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
03.06.2025
Completion date
01.06.2028
Registry ID
NCT06500988
Source
clinicaltrials.gov
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