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Atrial FibrillationNCT05810896

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

A study testing AF at Home in people with Atrial Fibrillation, run by University of North Carolina, Chapel Hill at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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: 1. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Atrial Fibrillation
What is being tested?
AF at Home
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
3 sitesUnited States
Study dates
12 Apr 2023to 25 Mar 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Unable to provide informed consent
  • Incarcerated patient

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • University of North Carolina, Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Duke University

    Durham, North Carolina, 27710

  • Wake Forest University

    Winston-Salem, North Carolina, 27109

Other trials in United States

About this study

Official title: 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.
Being tested
AF at Home
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT05810896
Study groupRoleWhat they receive
AF at HomeExperimentalAll recruited participants will participate in the AF at Home educational intervention.
Receives: Other: AF at Home

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and 3 weeks

Secondary outcomes (9)

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

    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).

    Measured: Baseline and 3 weeks

  2. Change in Cardiac Anxiety Questionnaire (CAQ)

    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.

    Measured: Baseline and 3 weeks

  3. Number of Patients Prescribed Appropriate Anticoagulation

    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.

    Measured: Baseline and 1-year post intervention session 6

  4. Number of Patients Prescribed Antiplatelet Therapy for AF Stroke Risk Reduction

    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.

    Measured: Baseline and 1-year post intervention session 6

  5. Number of Patients with Achievement of Blood Pressure at Target

    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.

    Measured: Baseline and 1-year post intervention session 6

  6. Number of Patients with Achievement of Heart Rate Target

    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.

    Measured: Baseline and 1-year post intervention session 6

  7. Number of Patients Prescribed Rhythm Controlling Medications

    This outcome will measure the number of patients who are prescribed rhythm controlling medications. This information will be collected from electronic health records.

    Measured: Baseline and 1-year post intervention session 6

  8. Number of Emergency Department Visits or Hospital Admissions for AF or Stroke (Healthcare Utilization)

    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.

    Measured: Baseline and 1-year post intervention session 6

  9. Change in Confidence in Atrial Fibrillation Management (CALM) Scale

    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.

    Measured: Baseline and 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2023
  2. Study start12 Apr 2023
  3. Primary completion25 Mar 2026
  4. Study completion25 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
Investigators will use a pre-test post-test model.
Masking
None (open label)
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05810896
Sponsor's protocol ID
22-1350b
Status last verified
Apr 2026
First submitted
30 Mar 2023
Last updated
27 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 30686041

  • 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.

    PubMed 31648734

  • 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.

    PubMed 33982364

  • 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.

    PubMed 33565642

Questions about this trial

What is this clinical trial studying?

A study testing AF at Home in people with Atrial Fibrillation, run by University of North Carolina, Chapel Hill at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change Atrial Fibrillation Effect on Quality-of-life Questionnaire (AFEQT) Score (time frame: Baseline and 3 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05810896, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.

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Clinical Trial NCT05810896 | AzTrials