Clinical trial NCT05810896: AF at Home: A Virtual Education Program for Patients With Atrial Fibrillation (AF)
Official title: Improving Outpatient Comprehensive Atrial Fibrillation Care Across Central North Carolina Through Direct Primary Care and Patient Engagement
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Duke University
name: Wake Forest University
name: Bristol-Myers Squibb
First posted: 2023-04-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Investigators will use a pre-test post-test model.
Primary purpose: SUPPORTIVE_CARE

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:

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Unable to provide informed consent
* Incarcerated patient

Primary outcomes:
measure: Change Atrial Fibrillation Effect on Quality-of-life Questionnaire (AFEQT) Score
timeFrame: Baseline and 3 weeks
Secondary outcomes:
measure: Change in Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29) Global Pain Intensity Scores
timeFrame: Baseline and 3 weeks
measure: Change in Cardiac Anxiety Questionnaire (CAQ)
timeFrame: Baseline and 3 weeks
measure: Number of Patients Prescribed Appropriate Anticoagulation
timeFrame: Baseline and 1-year post intervention session 6
measure: Number of Patients Prescribed Antiplatelet Therapy for AF Stroke Risk Reduction
timeFrame: Baseline and 1-year post intervention session 6
measure: Number of Patients with Achievement of Blood Pressure at Target
timeFrame: Baseline and 1-year post intervention session 6
measure: Number of Patients with Achievement of Heart Rate Target
timeFrame: Baseline and 1-year post intervention session 6
measure: Number of Patients Prescribed Rhythm Controlling Medications
timeFrame: Baseline and 1-year post intervention session 6
measure: Number of Emergency Department Visits or Hospital Admissions for AF or Stroke (Healthcare Utilization)
timeFrame: Baseline and 1-year post intervention session 6
measure: Change in Confidence in Atrial Fibrillation Management (CALM) Scale
timeFrame: Baseline and 3 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina, Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Anil Gehi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.