Recruiting

Digital AFib Tool

Sponsor:

Johns Hopkins University

Code:

NCT06500988

Conditions

Atrial Fibrillation

Behavior

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Corrie Virtual Atrial Fibrillation Management Program

Study Details

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

Study ID

NCT06500988

Start date

Jun 3, 2025

Status verified date

Apr, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

248 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Corrie Virtual Atrial Fibrillation Management Program

Multicomponent virtual atrial fibrillation management program

no intervention: Usual Care

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

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

Primary outcome measure

  • Participants Freedom from documented atrial tachyarrhythmia [ Time Frame: 91 to 365 days ]

Central Contacts and Locations

Central contacts

Nino Isakadze

410-955-5999nisakad1@jhmi.edu

Locations

Johns Hopkins Bayview Medical Center

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Natalie Horstman

443-839-0803nhorstm3@jh.edu

Johns Hopkins Outpatient Center

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Natalie Horstman

443-839-0803nhorstm3@jh.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Apr 20, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-04-20.