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

Atrial Fibrillation Clinical Trial

— AFibLITT_R  

Official title:

Mobile Health Intervention for Rural Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04076020
• Other study ID #: STUDY19050386
• Secondary ID: R01HL143010
• Status: Completed
• Phase: N/A
• Start date: January 8, 2020
• Est. completion date: August 2, 2023

Study information

• Verified date: May 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a randomized clinical trial to evaluate the effect of 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 usual care. Intervention participants will receive a contemporary mobile phone, commonly known and referred to herein as 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 FDA-approved instrument for heart rate and rhythm monitoring, which is named the "AliveCor KardiaMobile" device (herein referred to as the AliveCor Kardia), that pairs with the relational agent. Usual care participants will receive a smartphone as well, which will have the general health application called "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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: August 2, 2023
• Est. primary completion date: May 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Adult, age =21;

2. 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);

3. Prescribed use of warfarin or direct-acting oral anticoagulant (DOAC) for AF stroke prevention;

4. English-speaking well enough to participate in informed consent and this study;

5. 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 (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.

Related Conditions & MeSH terms

• Arrhythmia, Cardiac
• Arrhythmias, Cardiac
• Atrial Fibrillation
• Familial Atrial Fibrillation
• Heart Diseases
• Pathologic Processes

Intervention

Behavioral:
• Relational agent/AliveCor Kardia - Intervention
Use of the relational agent and Kardia daily for 120 days.
• Usual Care
Use of the WebMD app daily for 120 days.

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
University of Pittsburgh	Boston University, National Heart, Lung, and Blood Institute (NHLBI), Northeastern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Atrial Fibrillation Effect on Quality of Life (AFEQT)	The AFEQT is a widely used measure of atrial fibrillation-specific health-related quality of life which consists of a global score and 4 domains (symptoms, daily activities, treatment concerns, and treatment satisfaction). Overall or subscale scores range from 0-100 with higher scores indicating superior health-related quality of life in AF. A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered).	4, 8, and 12 months
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS)-29	Patient-Reported Outcomes Measurement Information System (PROMIS)-29 assesses 7 domains (physical function; depression and sadness; pain interference; satisfaction with participation in social roles and activities; fatigue; anxiety and fear; sleep disturbance), 4 questions each, and Pain Intensity with a single item. The 7 domain scores are transformed using a T-score with a mean of 50, standard deviation of 10, in a referent population. Higher scores indicate worse health for the depression, pain, fatigue, anxiety/sleep domains, while higher scores indicate better health for the physical function and satisfaction domains. The single Pain Intensity item is scored 0 (No pain) to 10 (Worst imaginable pain) in the past 7 days.; Further details on PROMIS scoring are available at https://www.healthmeasures.net/images/PROMIS/manuals/PROMIS_Adult_Profile_Scoring_Manual.pdf.	4, 8, and 12 months
Secondary	Emergency Room Visits	The number of participants with 1 or more emergency room visits will be quantified at 12 months. Data will be used to compare health care utilization between the two study arms.	12 months
Secondary	Hospital Admissions	The number of participants with one or more hospitalization will be quantified at 12 months. Data will be used to compare health care utilization between the two study arms.	12 months