Mobile Health Technology-Enabled AFib Management

Not Applicable

Not yet recruiting

• Conditions: Behavior; Atrial Fibrillation
• Interventions: Combination Product: Corrie Virtual Atrial Fibrillation Management Program

• Registration Number: NCT06500988
• Lead Sponsor: Johns Hopkins University

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-07-08
• Study First Posted: 2024-07-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-06
• Study Start: 2025-06-01
• Primary Completion: 2026-12
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 248

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Corrie Virtual Atrial Fibrillation Management Program	Corrie Virtual Atrial Fibrillation Management Program	Multicomponent virtual atrial fibrillation management program

Primary Outcome Measures

Name	Time	Method
Quality of Life as measured by Atrial Fibrillation Effect on Quality-of-Life (AFEQT) survey	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.