N/A
N=243
Atrial Fibrillation Health Literacy and Information Technology Trial
Atrial Fibrillation · Familial Atrial Fibrillation · Arrythmia, Cardiac · Heart Diseases · Pathologic Processes
Bottom Line
View on ClinicalTrials.gov: NCT04075994 ↗Enrolled (actual)
243
Serious AEs
23.1%
Results posted
May 2024
Primary outcome: Primary: Proportion of Days Covered — 1.0; 0.9 Proportion of days covered — p=0.22
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Relational Agent and heart rate and rhythm monitor (Behavioral); Usual Care (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Days Covered |
1.0; 0.9 | 0.22 |
| SECONDARY Self-reported Non-adherence |
99; 87; 12; 20; 99; 87 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS)-29 |
41.9; 41.9; 41.9; 41.9; 41.9; 43.5 | — |
| SECONDARY Atrial Fibrillation Effect on Quality of Life (AFEQT) |
77.8; 79.6; 79.6; 77.8; 76.9; 82.4 | — |
| SECONDARY Emergency Room (ER) Visits and Hospitalizations |
71; 163 | — |
| SECONDARY Days of Hospitalization |
292; 638 | — |
Summary
Atrial fibrillation (AF) is a common, morbid condition with increasing prevalence. Poor health-related quality of life is common in AF. Patients experience debilitating symptoms and challenging adherence to long-term (possibly lifelong) anticoagulation. The increased risks of stroke, heart failure and mortality associated with AF persist even with optimal treatment. Morbidity in AF is further exacerbated by social factors. Limited health literacy carries challenges of learning a specialized terminology and navigating specialized treatments. In multiple cardiovascular diseases, self-care has demonstrated improvement in self-efficacy, health-related quality of life, symptom burden, and health care utilization - essential components of patient success with AF. Selfcare can provide the critical skills to navigate a challenging chronic disease and improve patient-centered outcomes. Delivery of self-care as a mobile health intervention can complement standard care with a longitudinal intervention to improve patient-centered strategies for AF. While self-care interventions for AF have focused foremost on self-monitoring of anticoagulation,self-care has demonstrated its potential to meet the "triple aim" of improved patient experience, reduced health care utilization, and lower costs.
Eligibility Criteria
Inclusion Criteria
- Adult, age ≥21;
- Diagnosis of AF, identified from the electronic health record problem list and confirmed by 2 or more reports of AF from separate monitoring events at least 2 weeks apart (electrocardiogram, Holter or event monitor);
- CHA2DS2-VASc (heart failure, hypertension, age, diabetes, prior stroke or transient ischemic attack, coronary heart disease, female sex)≥2;
- Prescribed use of warfarin or direct-acting oral anticoagulant 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 nodal ablation or foreseen atrioventricular 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 (NCT04075994). 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.