Atrial Fibrillation Health Literacy and Information Technology Trial

NCT04075994 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 243

Last updated 2024-05-30

Study results available
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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.

Conditions

  • Atrial Fibrillation
  • Familial Atrial Fibrillation
  • Arrythmia, Cardiac
  • Heart Diseases
  • Pathologic Processes

Interventions

BEHAVIORAL

Relational Agent and heart rate and rhythm monitor

Use of the Relational Agent and heart rate and rhythm monitor daily for 120 days.

BEHAVIORAL

Usual Care

Use of the WebMD app and heart rate and rhythm monitor daily for 120 days.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH
  • Northeastern University

    collaborator OTHER
  • Boston University

    collaborator OTHER
  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Jared W Magnani, MD, MSc · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-02
Primary Completion
2023-04-11
Completion
2023-08-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04075994 on ClinicalTrials.gov