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

Primary Purpose

Atrial Fibrillation

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AF at Home
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patient with diagnosis of non-valvular or valvular atrial fibrillation Age >/= 18 Exclusion Criteria: Unable to provide informed consent Incarcerated patient

Sites / Locations

  • University of North Carolina, Chapel Hill
  • Duke University
  • Wake Forest University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AF at Home

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 30, 2023
Last Updated
May 3, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Duke University, Wake Forest University, Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT05810896
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 12, 2023 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Duke University, Wake Forest University, Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: Will participants in the educational program have improvement in quality of life, self-monitoring, and self-management strategies after program completion? 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Investigators will use a pre-test post-test model.
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AF at Home
Arm Type
Experimental
Arm Description
All recruited participants will participate in the AF at Home educational intervention.
Intervention Type
Other
Intervention Name(s)
AF at Home
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change Atrial Fibrillation Effect on Quality-of-life Questionnaire (AFEQT) Score
Description
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.
Time Frame
Baseline and 3 weeks
Secondary Outcome Measure Information:
Title
Change in Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29) Global Pain Intensity Scores
Description
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).
Time Frame
Baseline and 3 weeks
Title
Change in Cardiac Anxiety Questionnaire (CAQ)
Description
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.
Time Frame
Baseline and 3 weeks
Title
Number of Patients Prescribed Appropriate Anticoagulation
Description
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.
Time Frame
Baseline and 1-year post intervention session 6
Title
Number of Patients Prescribed Antiplatelet Therapy for AF Stroke Risk Reduction
Description
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.
Time Frame
Baseline and 1-year post intervention session 6
Title
Number of Patients with Achievement of Blood Pressure at Target
Description
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.
Time Frame
Baseline and 1-year post intervention session 6
Title
Number of Patients with Achievement of Heart Rate Target
Description
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.
Time Frame
Baseline and 1-year post intervention session 6
Title
Number of Patients Prescribed Rhythm Controlling Medications
Description
This outcome will measure the number of patients who are prescribed rhythm controlling medications. This information will be collected from electronic health records.
Time Frame
Baseline and 1-year post intervention session 6
Title
Number of Emergency Department Visits or Hospital Admissions for AF or Stroke (Healthcare Utilization)
Description
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.
Time Frame
Baseline and 1-year post intervention session 6
Title
Change in Confidence in Atrial Fibrillation Management (CALM) Scale
Description
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.
Time Frame
Baseline and 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anil Gehi, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina, Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
30686041
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. Erratum In: Circulation. 2019 Aug 6;140(6):e285.
Results Reference
background
PubMed Identifier
31648734
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.
Results Reference
background
PubMed Identifier
33982364
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.
Results Reference
background
PubMed Identifier
33565642
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.
Results Reference
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AF at Home: A Virtual Education Program for Patients With Atrial Fibrillation (AF)

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