N/A
N=270
Atrial Fibrillation Health Literacy and Information Technology Trial in Rural Pennsylvania Counties
Atrial Fibrillation · Familial Atrial Fibrillation · Arrhythmia, Cardiac · Heart Diseases · Pathologic Processes
Bottom Line
View on ClinicalTrials.gov: NCT04076020 ↗Enrolled (actual)
270
Serious AEs
24.4%
Results posted
May 2024
Primary outcome: Primary: Proportion of Days Covered — .97; 0.97 Proportion of days covered — p=0.99
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Relational agent/AliveCor Kardia - Intervention (Behavioral); Usual Care (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Days Covered |
.97; 0.97 | 0.99 |
| PRIMARY Self-reported Adherence |
112; 107; 5; 14; 106; 93 | <0.05 sig |
| SECONDARY Atrial Fibrillation Effect on Quality of Life (AFEQT) |
77.8; 75.9; 81.5; 79.6; 80.6; 77.8 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS)-29 |
41.4; 41.8; 41.9; 42.1; 41.4; 41.7 | — |
| SECONDARY Emergency Room Visits |
92; 92; 43; 43 | — |
| SECONDARY Hospital Admissions |
99; 103; 36; 32 | — |
Summary
Atrial fibrillation (AF) is a highly prevalent, morbid condition. Anticoagulation to prevent thromboembolic strokes is a foremost priority in AF but adherence is challenging for patients and lapses in anticoagulation are common. Chronic disease self-management (CDSM) is a recognized program to enhance self-efficacy and improve adherence, quality of life, and patient-centered health outcomes. Rural patients with AF experience increased vulnerability to adverse outcomes due to geographic and social isolation, poor health care access, and limited health literacy. This study uses an innovative, scalable CDSM intervention to improve anticoagulation adherence in rural patients with AF.
Eligibility Criteria
Inclusion Criteria
- Adult, age ≥21;
- Diagnosis of AF, identified from the electronic health record (EHR) problem list and confirmed by 2 or more reports of AF from separate monitoring events at least 2 weeks apart (CG, Holter or event monitor);
- Prescribed use of warfarin or direct-acting oral anticoagulant (DOAC) for AF stroke prevention;
- English-speaking well enough to participate in informed consent and this study;
- No plans to relocate from the area within 12 months of enrollment.
Exclusion Criteria
- Conditions other than AF that require anticoagulation, such as mechanical prosthetic valve, deep vein thrombosis, or pulmonary embolism;
- History of pulmonary vein isolation or foreseen pulmonary vein isolation;
- History of atrioventricular (AV) nodal ablation or foreseen AV nodal ablation;
- Heart failure necessitating hospital admission ≤3 months prior to study inclusion;
- Acute coronary syndrome (defined as at least 2 of the following: chest pain, ischemic electrocardiographic changes, or troponin ≥0.1 ng/mL) ≤3 months prior to study inclusion;
- Untreated hyperthyroidism or ≤3 months euthyroidism before inclusion;
- Foreseen pacemaker, internal cardioverter defibrillator, or cardiac resynchronization therapy;
- Cardiac surgery ≤3 months before inclusion;
- Planned cardiac surgery;
- Presence of non-cardiovascular conditions likely to be fatal within 12 months (e.g., cancer);
- Inability to comprehend the study protocol, defined as failing to answer correctly a set of questions on orientation and short-term memory during the consent process.
Data sourced from ClinicalTrials.gov (NCT04076020). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.