AF at Home: A Virtual Education Program for Patients With Atrial Fibrillation (AF)

NCT ID: NCT05810896

Last Updated: 2025-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-12

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this study is to determine the effectiveness of a direct-to-patient virtual education program ("AF at Home") for adults with atrial fibrillation (AF). The main questions this study aims to answer are:

1. Will participants in the educational program have improvement in quality of life, self-monitoring, and self-management strategies after program completion?
2. Will patient level quality of AF care improve for participants in the educational program?

Participants will be asked to:

* Participate in six hours of virtual education sessions over three weeks via Zoom.
* Complete online questionnaires before the program starts and after its completion.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Investigators will use a pre-test post-test model.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AF at Home

All recruited participants will participate in the AF at Home educational intervention.

Group Type EXPERIMENTAL

AF at Home

Intervention Type OTHER

The AF at Home education program will be delivered via Zoom videoconferencing technology and will include 6, 1-hour long sessions that involve education on AF self-monitoring and self-management. Each session will include a didactic presentation and open Q\&A. Supplementary educations materials will be made available to participants.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AF at Home

The AF at Home education program will be delivered via Zoom videoconferencing technology and will include 6, 1-hour long sessions that involve education on AF self-monitoring and self-management. Each session will include a didactic presentation and open Q\&A. Supplementary educations materials will be made available to participants.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patient with diagnosis of non-valvular or valvular atrial fibrillation
* Age \>/= 18

Exclusion Criteria

* Unable to provide informed consent
* Incarcerated patient
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Duke University

OTHER

Sponsor Role collaborator

Wake Forest University

OTHER

Sponsor Role collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anil Gehi, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Duke University

Durham, North Carolina, United States

Site Status

Wake Forest University

Winston-Salem, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

January CT, Wann LS, Calkins H, Chen LY, Cigarroa JE, Cleveland JC Jr, Ellinor PT, Ezekowitz MD, Field ME, Furie KL, Heidenreich PA, Murray KT, Shea JB, Tracy CM, Yancy CW. 2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society in Collaboration With the Society of Thoracic Surgeons. Circulation. 2019 Jul 9;140(2):e125-e151. doi: 10.1161/CIR.0000000000000665. Epub 2019 Jan 28. No abstract available.

Reference Type BACKGROUND
PMID: 30686041 (View on PubMed)

Gallagher C, Rowett D, Nyfort-Hansen K, Simmons S, Brooks AG, Moss JR, Middeldorp ME, Hendriks JM, Jones T, Mahajan R, Lau DH, Sanders P. Patient-Centered Educational Resources for Atrial Fibrillation. JACC Clin Electrophysiol. 2019 Oct;5(10):1101-1114. doi: 10.1016/j.jacep.2019.08.007. Epub 2019 Sep 1.

Reference Type BACKGROUND
PMID: 31648734 (View on PubMed)

Tripp C, Gehi AK, Rosman L, Anthony S, Sears SF. Measurement of patient confidence in self-management of atrial fibrillation: Initial validation of the Confidence in Atrial fibriLlation Management (CALM) Scale. J Cardiovasc Electrophysiol. 2021 Jun;32(6):1640-1645. doi: 10.1111/jce.15050. Epub 2021 May 12.

Reference Type BACKGROUND
PMID: 33982364 (View on PubMed)

Rosman L, Armbruster T, Kyazimzade S, Tugaoen Z, Mazzella AJ, Deyo Z, Walker J, Machineni S, Gehi A. Effect of a virtual self-management intervention for atrial fibrillation during the outbreak of COVID-19. Pacing Clin Electrophysiol. 2021 Mar;44(3):451-461. doi: 10.1111/pace.14188. Epub 2021 Feb 17.

Reference Type BACKGROUND
PMID: 33565642 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

22-1350b

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.