Patient Centered Mobile Health Technology-Enabled Atrial Fibrillation Management: Phase 2
Overview
- Phase
- N/A
- Intervention
- Corrie Virtual Atrial Fibrillation Management Program
- Conditions
- Atrial Fibrillation
- Sponsor
- Johns Hopkins University
- Enrollment
- 248
- Locations
- 2
- Primary Endpoint
- Quality of Life as measured by Atrial Fibrillation Effect on Quality-of-Life (AFEQT) survey
- Status
- Recruiting
- Last Updated
- 12 days ago
Overview
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)
Investigators
Eligibility Criteria
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
Arms & Interventions
Corrie Virtual Atrial Fibrillation Management Program
Multicomponent virtual atrial fibrillation management program
Intervention: Corrie Virtual Atrial Fibrillation Management Program
Usual Care
Receives usual care. Usual care is defined as care according to the patients care team's standard practice
Outcomes
Primary Outcomes
Quality of Life as measured by Atrial Fibrillation Effect on Quality-of-Life (AFEQT) survey
Time Frame: 6 months
Measured by Atrial Fibrillation Effect on Quality-of-Life (AFEQT), which consists of 20 items. Score ranges from 0 to 100 with higher scores signifying better quality of life.
Participants Freedom from documented atrial tachyarrhythmia
Time Frame: 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 Outcomes
- Quality of Life as assessed by Atrial Fibrillation Effect on Quality of Life (AFEQT)(365 days)
- AFib burden (percentage of time)(91 to 365 days)
- Participants Freedom from atrial tachyarrhythmia off medication(91 to 365 days)
- Participants Freedom from atrial tachyarrhythmia on or off medications(1 day to 365 days)
- Safety as assessed by hospitalizations, emergency room visits, deaths(1 to 365 days)
- Incidence of hospitalizations, emergency room visits, deaths(1 to 365 days)