Atrial Fibrillation Health Literacy and Information Technology Trial (AFibLITT)

University of Pittsburgh

Status: Completed

Conditions: Atrial Fibrillation; Familial Atrial Fibrillation; Arrythmia, Cardiac; Heart Diseases; Pathologic Processes

Treatments: Behavioral: Relational Agent and heart rate and rhythm monitor; Behavioral: Usual Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04075994

STUDY18110147

R61HL144669 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

This is a randomized clinical trial to evaluate the effect of a smartphone-based intervention called a relational agent on health outcomes in people with atrial fibrillation. The study will enroll 240 patients who reside in Pittsburgh-area with this condition and will randomize them to the intervention or control. Intervention participants will receive a smartphone with the agent, which simulates conversation. In addition they will receive an AliveCor Kardia for heart rate and rhythm monitoring, an FDA-approved, widely used instrument that pairs with the smartphone. Control participants will receive a smartphone with WebMD, a brochure published by the American Heart Association that describes AF, and an AliveCor Kardia. The intervention will last 4 months and participants will have visits at baseline, 4, 8 and 12 months. The study will evaluate the improvement in quality of life, medical adherence and health care utilization resulting from the intervention.

Enrollment: 243 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult, age ≥21;
2. 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);
3. CHA2DS2-VASc (heart failure, hypertension, age, diabetes, prior stroke or transient ischemic attack, coronary heart disease, female sex)≥2;
4. Prescribed use of warfarin or direct-acting oral anticoagulant for AF stroke prevention;
5. English-speaking well enough to participate in informed consent and this study;
6. No plans to relocate from the area within 12 months of enrollment.

Exclusion criteria

1. Conditions other than AF that require anticoagulation, such as mechanical prosthetic valve, deep vein thrombosis, or pulmonary embolism;
2. History of pulmonary vein isolation or foreseen pulmonary vein isolation;
3. History of atrioventricular nodal ablation or foreseen atrioventricular nodal ablation;
4. Heart failure necessitating hospital admission ≤3 months prior to study inclusion;
5. 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;
6. Untreated hyperthyroidism or ≤3 months euthyroidism before inclusion;
7. Foreseen pacemaker, internal cardioverter defibrillator, or cardiac resynchronization therapy;
8. Cardiac surgery ≤3 months before inclusion;
9. Planned cardiac surgery;
10. Presence of non-cardiovascular conditions likely to be fatal within 12 months (e.g., cancer);
11. 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

243 participants in 2 patient groups

Intervention arm

Experimental group

Description:

Receive the relational agent coupled with the AliveCor Kardia heart rate and rhythm monitor for 120-day use.

Treatment:

Behavioral: Relational Agent and heart rate and rhythm monitor

Usual care arm

Active Comparator group

Description:

Receive a brochure on atrial fibrillation, the WebMD app and the AliveCor Kardia heart rate and rhythm monitor for 120-day use.

Treatment:

Behavioral: Usual Care