Atrial Fibrillation Health Literacy and Information Technology Trial in Rural PA Counties (AFibLITT_R)

• ClinicalTrials.gov Identifier: NCT04076020
• Recruitment Status: Active, not recruiting
• First Posted: September 3, 2019
• Last Update Posted: January 6, 2023
• Sponsor: University of Pittsburgh
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Northeastern University; Boston University
• Information provided by (Responsible Party): Jared W Magnani, MD, MSc, University of Pittsburgh

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Atrial Fibrillation; Familial Atrial Fibrillation; Arrhythmia, Cardiac; Heart Diseases; Pathologic Processes	Behavioral: Relational agent/AliveCor Kardia - Intervention Group; Behavioral: Usual Care	Not Applicable

Detailed Description:

This is a randomized clinical trial to evaluate the effect of a smartphone-based intervention called an embodied conversational agent (ECA) on health outcomes in people with atrial fibrillation. The study will enroll 264 patients who reside in rural, Western Pennsylvania who have atrial fibrillation. Participants will be randomized to the intervention or control. Intervention participants will receive a smartphone with a relational agent, which simulates conversation and provides coaching, guidance, and assistance with chronic disease self-management. In addition participants will receive an AliveCor Kardia for heart rate and rhythm monitoring, an FDA-approved, widely used instrument that pairs with the relational agent. Control participants will receive a smartphone with as well, which will have the health application WebMD. 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 adherence to anticoagulation, quality of life, and health care utilization resulting from the intervention.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 270 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: Telephone assessors conducting the 8- and 12-month assessments will be masked.
• Primary Purpose: Health Services Research
• Official Title: Mobile Health Intervention for Rural Atrial Fibrillation
• Actual Study Start Date: January 8, 2020
• Estimated Primary Completion Date: June 30, 2023
• Estimated Study Completion Date: August 31, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention arm; 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 Group; Use of the relational agent and Kardia daily for 120 days.
Active Comparator: Usual care arm; 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; Use of the WebMD app daily for 120 days.

Outcome Measures

Primary Outcome Measures :

1. Medication possession ratio [ Time Frame: 12 months ]
   Medication Possession Ratio (MPR) is obtained from electronic prescription and pharmacy fill data for oral anticoagulation. MPR is calculated as a percentage (0 to 100%) accounting for days of prescription and date of fill. MPR quantification accounts for days of hospitalization, switching to an alternative anticoagulant agent, and prescribing changes during 12-month follow-up.

Secondary Outcome Measures :

1. Self-reported adherence [ Time Frame: 4, 8 and 12 months ]
   A three-item instrument to ascertain self-reported non-adherence. Items are scored with a Likert scale from 0 ("None fo the time.") to 5 ("Every time."). The score is scaled as a continuous measure (0 to 15) and dichotomous categorization.
2. Change from baseline Atrial Fibrillation Effect on QualiTy of life (AFEQT) at 4, 8 and 12 months [ Time Frame: Baseline, 4, 8 and 12 months ]
   The AFEQT is a widely used measure of atrial fibrillation-specific health-related quality of life. Scores range from 0 to 100 with higher scores indicating superior health-related quality of life in AF. The AFEQT measure consists of a global score and 4 domains (symptoms, daily activities, treatment concerns, and treatment satisfaction). We prioritize the global score because of its specificity to AF, our experience with this measure in our preliminary and pilot studies, extensive validation, and ease of administration. The AFEQT subdomains (symptoms, daily activities, treatment concerns, and treatment satisfaction) constitute secondary outcomes.
3. Emergency room visits [ Time Frame: 4, 8 and 12 months ]
   The number of emergency room visits will be quantified at 4, 8 and 12 months. These data will be used to compare health care utilization between the two study arms.
4. Urgent care visits [ Time Frame: 4, 8 and 12 months ]
   The number of urgent care visits will be quantified at 4, 8 and 12 months. These data will be used to compare health care utilization between the two study arms.
5. Days of hospitalization [ Time Frame: 4, 8 and 12 months ]
   The number of days of hospitalization will be quantified at 4, 8 and 12 months. These data will be used to compare health care utilization between the two study arms.

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Adult, age ≥18;
2. Diagnosis of AF, identified from the 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);
3. CHA2DS2-VASc (heart failure, hypertension, age, diabetes, prior stroke/TIA, CD, female sex)≥2;
4. Prescribed use of warfarin or DOAC (formerly NOAC) 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 AV nodal ablation or foreseen AV 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.

Contacts and Locations

Locations

United States, Pennsylvania

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

University of Pittsburgh

National Heart, Lung, and Blood Institute (NHLBI)

Northeastern University

Boston University

Investigators

• Principal Investigator: Jared W. Magnani, MD, MSc; University of Pittsburgh

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Jared W Magnani, MD, MSc, Associate Professor, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT04076020
• Other Study ID Numbers: STUDY19050386; R01HL143010 ( U.S. NIH Grant/Contract )
• First Posted: September 3, 2019
• Last Update Posted: January 6, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: The study team will share individual participant data that underlie the results reported in the study's central manuscripts after deidentification (text, tables, figures, and appendices).
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jared W Magnani, MD, MSc, University of Pittsburgh:

Adherence; Health Literacy; quality of life

Additional relevant MeSH terms:

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