NCT05810896

Brief Summary

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:

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable atrial-fibrillation

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

April 12, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 13, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2026

Completed
Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

3 years

First QC Date

March 30, 2023

Last Update Submit

April 23, 2026

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Change Atrial Fibrillation Effect on Quality-of-life Questionnaire (AFEQT) Score

    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 Outcomes (9)

  • Change in Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29) Global Pain Intensity Scores

    Baseline and 3 weeks

  • Change in Cardiac Anxiety Questionnaire (CAQ)

    Baseline and 3 weeks

  • Number of Patients Prescribed Appropriate Anticoagulation

    Baseline and 1-year post intervention session 6

  • Number of Patients Prescribed Antiplatelet Therapy for AF Stroke Risk Reduction

    Baseline and 1-year post intervention session 6

  • Number of Patients with Achievement of Blood Pressure at Target

    Baseline and 1-year post intervention session 6

  • +4 more secondary outcomes

Study Arms (1)

AF at Home

EXPERIMENTAL

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

Other: AF at Home

Interventions

AF at HomeOTHER

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.

AF at Home

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Unable to provide informed consent
  • Incarcerated patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27109, United States

Location

Related Publications (4)

  • 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.

    PMID: 30686041BACKGROUND

  • 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.

    PMID: 31648734BACKGROUND

  • 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.

    PMID: 33982364BACKGROUND

  • 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.

    PMID: 33565642BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Anil Gehi, MD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Investigators will use a pre-test post-test model.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2023

First Posted

April 13, 2023

Study Start

April 12, 2023

Primary Completion

March 25, 2026

Study Completion

March 25, 2026

Last Updated

April 27, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Deidentified individual data that supports the results will be shared beginning 12 to 36 months following publication.
Access Criteria
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US(3)