Atrial Fibrillation, Behavior
Conditions
Keywords
Remote Patient Monitoring, Atrial Fibrillation, Risk Factor Modification, Digital Health, Mobile Health
Brief summary
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)
Interventions
COMBINATION_PRODUCTCorrie Virtual Atrial Fibrillation Management Program
Intervention aims to implement a comprehensive digital atrial fibrilation guideline-recommended toolkit
Sponsors
Johns Hopkins University
Pharmaceutical Research & Manufacturers Of America Foundation
Apple Inc.
Itamar-Medical, Israel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants Freedom from documented atrial tachyarrhythmia | 91 to 365 days | Freedom from documented atrial tachyarrhythmia (atrial fibrillation/atrial flutter/atrial tachycardia) episodes of ≥30 seconds between 91 and 365 days after catheter ablation, on or off antiarrhythmic drugs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life as assessed by Atrial Fibrillation Effect on Quality of Life (AFEQT) | 365 days | Quality of Life, measured by validated Atrial Fibrillation Effect on Quality of Life (AFEQT) score. Score ranges from 0 to 100 with higher scores signifying better quality of life |
| AFib burden (percentage of time) | 91 to 365 days | Atrial fibrillation burden (expressed as a percentage of time in atrial fibrillation) between 91 days and 365 days after catheter ablation |
| Participants Freedom from atrial tachyarrhythmia off medication | 91 to 365 days | Freedom from atrial tachyarrhythmia episodes ≥30 seconds in duration between 91 days and 365 days after catheter ablation off medications. |
| Participants Freedom from atrial tachyarrhythmia on or off medications | 1 day to 365 days | Freedom from atrial tachyarrhythmia episodes ≥30 seconds in duration between day 1 and day 365 after catheter ablation, on and off medications. |
| Incidence of hospitalizations, emergency room visits, deaths | 1 to 365 days | Safety (composite of hospitalizations, emergency room visits, deaths) |
Countries
United States
Contacts
CONTACTNino Isakadze
PRINCIPAL_INVESTIGATORNino Isakadze, MD
Johns Hopkins University
Outcome results
None listed