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

Not Applicable

• Conditions: Atrial Fibrillation
• Interventions: Other: AF at Home

• Registration Number: NCT05810896
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-30
• Study First Submitted QC: 2023-03-30
• Study Start: 2023-04-12
• Study First Posted: 2023-04-13
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

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Exclusion Criteria

• Unable to provide informed consent
• Incarcerated patient

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change Atrial Fibrillation Effect on Quality-of-life Questionnaire (AFEQT) Score	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.

Secondary Outcome Measures

Name	Time	Method
Change in Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29) Global Pain Intensity Scores	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).
Change in Cardiac Anxiety Questionnaire (CAQ)	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.
Number of Patients Prescribed Appropriate Anticoagulation	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.
Number of Patients Prescribed Antiplatelet Therapy for AF Stroke Risk Reduction	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.
Number of Patients with Achievement of Blood Pressure at Target	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.
Number of Patients with Achievement of Heart Rate Target	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.
Number of Patients Prescribed Rhythm Controlling Medications	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.
Number of Emergency Department Visits or Hospital Admissions for AF or Stroke (Healthcare Utilization)	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.
Change in Confidence in Atrial Fibrillation Management (CALM) Scale	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.

Trial Locations

Locations (3)

Duke University; 🇺🇸 Durham, North Carolina, United States

University of North Carolina, Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States