Atrial Fibrillation
Conditions
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.
Interventions
OTHERAF at Home
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.
Sponsors
University of North Carolina, Chapel Hill
Duke University
Wake Forest University
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Investigators will use a pre-test post-test model.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patient with diagnosis of non-valvular or valvular atrial fibrillation * Age \>/= 18
Exclusion criteria
* Unable to provide informed consent * Incarcerated patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAnil Gehi, MD
University of North Carolina, Chapel Hill
Outcome results
None listed