Mobile Health Technology-Enabled AFib Management

NCT06500988 | Recruiting DMC

• 1 other identifier: IRB00453569
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 2

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)

Conditions

Atrial Fibrillation; Behavior

Keywords

Remote Patient Monitoring; Atrial Fibrillation; Risk Factor Modification; Digital Health; Mobile Health

Outcome Measures

Primary Outcomes (1)

• Participants Freedom from documented atrial tachyarrhythmia

  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.

  91 to 365 days

Secondary Outcomes (5)

• 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

Study Arms (2)

Corrie Virtual Atrial Fibrillation Management Program

EXPERIMENTAL

Multicomponent virtual atrial fibrillation management program

Combination Product: Corrie Virtual Atrial Fibrillation Management Program

Usual Care

NO INTERVENTION

Receives usual care. Usual care is defined as care according to the patients care team's standard practice

Interventions

Corrie Virtual Atrial Fibrillation Management Program COMBINATION_PRODUCT

Intervention aims to implement a comprehensive digital atrial fibrilation guideline-recommended toolkit

Corrie Virtual Atrial Fibrillation Management Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Pharmaceutical Research & Manufacturers Of America Foundation: collaborator
• Apple Inc.: collaborator
• Itamar-Medical, Israel: collaborator

Study Sites (2)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

RECRUITING

Johns Hopkins Outpatient Center

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Behavior

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nino Isakadze, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nino Isakadze

CONTACT

410-955-5999; nisakad1@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 15, 2024
• Study Start: June 3, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)