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

April 23, 2026 updated by: University of North Carolina, Chapel Hill

Improving Outpatient Comprehensive Atrial Fibrillation Care Across Central North Carolina Through Direct Primary Care and Patient Engagement

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina, Chapel Hill
      • Durham, North Carolina, United States, 27710
        • Duke University
      • Winston-Salem, North Carolina, United States, 27109
        • Wake Forest University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Unable to provide informed consent
  • Incarcerated patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AF at Home
All recruited participants will participate in the AF at Home educational intervention.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change Atrial Fibrillation Effect on Quality-of-life Questionnaire (AFEQT) Score
Time Frame: Baseline and 3 weeks
The AFEQT questionnaire is a validated tool used to measure self-reported quality of life specifically for patients with atrial fibrillation. The questionnaire includes 20 questions measured on a 7-point Likert scale (1= not at all to 7=extremely) with 3 subcategories. The subcategories include symptoms (questions 1-4), daily activities (questions 5-12), and treatment concerns (questions 13-18). Scoring provides an overall AFEQT score (based on questions 1-18), and a treatment satisfaction score (based on questions 19-20). Treatment satisfaction scores are not included in the overall AFEQT score. Overall or subcategory scores range from 0-100. A score of 100 corresponds to no disability, and a score of 0 corresponds to total disability.
Baseline and 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29) Global Pain Intensity Scores
Time Frame: Baseline and 3 weeks
The PROMIS-29 questionnaire measures pain intensity across 7 domains with 4 questions in each domain (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain interference), and one global pain intensity question. Each domain score ranges from 4-20 with higher scores indicating more of the symptom being measured. Global pain intensity score ranges from 0-10 (0-no pain to 10=highest pain level).
Baseline and 3 weeks
Change in Cardiac Anxiety Questionnaire (CAQ)
Time Frame: Baseline and 3 weeks
The CAQ is a self-reported measure that assesses anxiety related specifically to cardiac symptoms. The CAQ contains 18 questions rated on a 5-point Likert scale (0=never to 4=always). The questionnaire contains 3 subcategories including fear (8 questions), avoidance (5 questions), and attention (5 questions). The higher the score, the more symptoms and or frequency.
Baseline and 3 weeks
Number of Patients Prescribed Appropriate Anticoagulation
Time Frame: Baseline and 1-year post intervention session 6
This outcome measures the Number of patients prescribed appropriate anticoagulation medication based on risk factors for stroke including congestive heart failure (C), hypertension (H), Age >74 (A2), Diabetes (D), prior stroke or transient ischemic attack (TIA) (S2), vascular disease (V), age 65-74 (A), female sex (Sc), commonly referred to as CHA2DS2-VASc stroke risk score for patients with atrial fibrillation. CHA2DS2-VASc score includes 7 indicators of stroke risk (age (<65=0, 65-74=1, 75+= 2), sex (male=0, female=1), heart failure (no=0, yes=1), hypertension (no=0, yes=1), prior stroke/TIA (no=0, yes=2), history of vascular disease (no=0, yes=1), and diabetes (no=0, yes=1). Anticoagulation is indicated for a female with a score 3 or higher and males with a score of 2 or higher. This information will be collected from electronic health records.
Baseline and 1-year post intervention session 6
Number of Patients Prescribed Antiplatelet Therapy for AF Stroke Risk Reduction
Time Frame: Baseline and 1-year post intervention session 6
This outcome will measure the number of patients who were prescribed antiplatelet therapy for atrial fibrillation stroke risk reduction without comorbid vascular disease. This information will be collected from electronic health records.
Baseline and 1-year post intervention session 6
Number of Patients with Achievement of Blood Pressure at Target
Time Frame: Baseline and 1-year post intervention session 6
This outcome will measure the number of patients meeting guideline blood pressure target of systolic blood pressure (SBP) <130 mmHg.This information will be collected from electronic health records.
Baseline and 1-year post intervention session 6
Number of Patients with Achievement of Heart Rate Target
Time Frame: Baseline and 1-year post intervention session 6
This outcome will measure the number of patients meeting guideline heart rate target of <110 beats per minute (bpm). This information will be collected from electronic health records.
Baseline and 1-year post intervention session 6
Number of Patients Prescribed Rhythm Controlling Medications
Time Frame: Baseline and 1-year post intervention session 6
This outcome will measure the number of patients who are prescribed rhythm controlling medications. This information will be collected from electronic health records.
Baseline and 1-year post intervention session 6
Number of Emergency Department Visits or Hospital Admissions for AF or Stroke (Healthcare Utilization)
Time Frame: Baseline and 1-year post intervention session 6
This outcome will measure the number of emergency room visits and/or hospital admissions with a primary or secondary diagnosis of atrial fibrillation or stroke. This information will be collected from electronic health records.
Baseline and 1-year post intervention session 6
Change in Confidence in Atrial Fibrillation Management (CALM) Scale
Time Frame: Baseline and 3 weeks
The CALM scale is a newly developed tool to assess self-reported confidence in self-management skills for patients with AF. The CALM scale contains 16 questions to indicate the level of confidence in each item on a range of 0-4 (not confident =0, to extremely confident=3). The higher the score, the more confident in self-management skills.
Baseline and 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Bristol-Myers Squibb
Duke University
Wake Forest University

Investigators

  • Principal Investigator: Anil Gehi, MD, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2023

Primary Completion (Actual)

March 25, 2026

Study Completion (Actual)

March 25, 2026

Study Registration Dates

First Submitted

March 30, 2023

First Submitted That Met QC Criteria

March 30, 2023

First Posted (Actual)

April 13, 2023

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-1350b

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual data that supports the results will be shared beginning 12 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

IPD Sharing Time Frame

Deidentified individual data that supports the results will be shared beginning 12 to 36 months following publication.

IPD Sharing Access Criteria

Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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