Atrial Fibrillation Health Literacy and Information Technology Trial in Rural Pennsylvania Counties

NCT04076020 | Completed Results DMC

• 2 other identifiers: STUDY19050386R01HL143010
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation; Familial Atrial Fibrillation; Arrhythmia, Cardiac; Heart Diseases; Pathologic Processes

Keywords

Adherence; Health Literacy; quality of life

Outcome Measures

Primary Outcomes (2)

• 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. PDC range is 0 to 1.00 with higher values indicating greater proportion of days with medication as indicated by pharmacy records.

  12 months

• Self-reported Adherence

  Self-reported adherence to oral anticoagulation. 3-item instrument with range 1-5 such that lower scores indicate more frequent medication adherence. Here the score is dichotomized by classifying participants reporting 1 for all three items as adherent and those that reported ≥ 2 on any item as non-adherent.

  4, 8, and 12 months

Secondary Outcomes (4)

• Atrial Fibrillation Effect on Quality of Life (AFEQT)

  4, 8, and 12 months

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

  4, 8, and 12 months

• Emergency Room Visits

  12 months

• Hospital Admissions

  12 months

Study Arms (2)

Intervention

EXPERIMENTAL

Receive the relational agent and the AliveCor Kardia for use for 120 days. Participants are directed to use these interventions daily.

Behavioral: Relational agent/AliveCor Kardia - Intervention

Usual Care

ACTIVE COMPARATOR

Receive a brochure on atrial fibrillation that is published by the American Heart Association and a smartphone with the WebMD application. Participants are directed to use the WebMD application as often as they would like.

Behavioral: Usual Care

Interventions

Relational agent/AliveCor Kardia - Intervention BEHAVIORAL

Use of the relational agent and Kardia daily for 120 days.

Intervention

Usual Care BEHAVIORAL

Use of the WebMD app daily for 120 days.

Usual Care

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 (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.

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 (AV) nodal ablation or foreseen AV 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)

• Mann HK, Streiff M, Schultz KC, Halpern DV, Ferry D, Johnson AE, Magnani JW. Rurality and Atrial Fibrillation: Patient Perceptions of Barriers and Facilitators to Care. J Am Heart Assoc. 2023 Nov 7;12(21):e031152. doi: 10.1161/JAHA.123.031152. Epub 2023 Oct 27.

  PMID: 37889198 DERIVED

• Palmer MJ, Machiyama K, Woodd S, Gubijev A, Barnard S, Russell S, Perel P, Free C. Mobile phone-based interventions for improving adherence to medication prescribed for the primary prevention of cardiovascular disease in adults. Cochrane Database Syst Rev. 2021 Mar 26;3(3):CD012675. doi: 10.1002/14651858.CD012675.pub3.

  PMID: 33769555 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Pathological Conditions, Signs and Symptoms

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 8, 2020
• Primary Completion: May 27, 2023
• Study Completion: August 2, 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)