Atrial Fibrillation Health Literacy and Information Technology Trial

NCT04075994 | Completed Results DMC

• 2 other identifiers: STUDY18110147R61HL144669
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Quality of Life (QoL); Adherence; Health Literacy

Outcome Measures

Primary Outcomes (1)

• Proportion of Days Covered

  Proportion of Days Covered (PDC), obtained from collection of electronic prescription and pharmacy fill data, and defined as the proportion of availability of medication for the period of interest, here the period from the date of the baseline to the 12-month examination. PDC range is 0 to 1.00 with higher values indicating greater proportion of days with medication over the 12-month period of study participation as indicated by pharmacy records.

  12 months

Secondary Outcomes (5)

• Self-reported Non-adherence

  4, 8 and 12 months

• Patient-Reported Outcomes Measurement Information System (PROMIS)-29

  4, 8, and 12 months

• Atrial Fibrillation Effect on Quality of Life (AFEQT)

  4, 8 and 12 months

• Emergency Room (ER) Visits and Hospitalizations

  12 months

• Days of Hospitalization

  12 months

Study Arms (2)

Intervention arm

EXPERIMENTAL

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

Behavioral: Relational Agent and heart rate and rhythm monitor

Usual care arm

ACTIVE COMPARATOR

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

Behavioral: Usual Care

Interventions

Relational Agent and heart rate and rhythm monitor BEHAVIORAL

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

Intervention arm

Usual Care BEHAVIORAL

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

Usual care arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Foreseen pacemaker, internal cardioverter defibrillator, or cardiac resynchronization therapy;
• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Northeastern University: collaborator
• Boston University: collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

• Magnani JW, Lalama CM, Abebe KZ, Ferry D, Rollman BL, Lancet MQ, Kimani E, Olafsson S, Bickmore T, Paasche-Orlow MK. A mobile relational agent to enhance atrial fibrillation self-care: Primary and secondary outcomes of a randomized controlled trial. Am Heart J. 2025 Dec;290:115-128. doi: 10.1016/j.ahj.2025.06.009. Epub 2025 Jun 20.

  PMID: 40545207 DERIVED

• Althouse AD, Abebe KZ, Paasche-Orlow MK, Lalama CM, Ferry D, Lancet M, Swabe G, Bickmore T, Magnani JW. Design, rationale, and baseline characteristics of a randomized controlled trial evaluating a mobile relational agent to enhance atrial fibrillation self-care. Contemp Clin Trials. 2023 Jan;124:107015. doi: 10.1016/j.cct.2022.107015. Epub 2022 Nov 17.

  PMID: 36402276 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes

Interventions

Heart Rate

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Results Point of Contact

• Title: Dr. Jared Magnani
• Organization: University of Pittsburgh

magnanij@pitt.edu

(412)383-0611

Study Officials

• Jared W Magnani, MD, MSc

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: September 3, 2019
• Study Start: January 2, 2020
• Primary Completion: April 11, 2023
• Study Completion: August 1, 2023
• Last Updated: May 30, 2024
• Results First Posted: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Such data will be available beginning 9 months and ending 36 months following publication of the main manuscripts resulting from this clinical trial.
• Access Criteria: Data will be made available to those investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Proposals may be submitted up to 36 months following article publication. Applicants requesting access to the data will be responsible for the minimal administrative costs to provide the data set.

Locations

US (1)