Atrial Fibrillation Health Literacy and Information Technology Trial in Rural PA Counties (AFibLITT_R)
Primary Purpose
Atrial Fibrillation, Familial Atrial Fibrillation, Arrhythmia, Cardiac
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Relational agent/AliveCor Kardia - Intervention Group
Usual Care
Sponsored by
About this trial
This is an interventional health services research trial for Atrial Fibrillation focused on measuring Adherence, Health Literacy, quality of life
Eligibility Criteria
Inclusion Criteria:
- Adult, age ≥18;
- 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);
- CHA2DS2-VASc (heart failure, hypertension, age, diabetes, prior stroke/TIA, CD, female sex)≥2;
- Prescribed use of warfarin or DOAC (formerly NOAC) 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.
Exclusion Criteria:
- 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 AV nodal ablation or foreseen AV nodal ablation;
- Heart failure necessitating hospital admission ≤3 months prior to study inclusion;
- 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;
- Untreated hyperthyroidism or ≤3 months euthyroidism before inclusion;
- Foreseen pacemaker, internal cardioverter defibrillator, or cardiac resynchronization therapy;
- Cardiac surgery ≤3 months before inclusion;
- 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.
Sites / Locations
- University of Pittsburgh Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention arm
Usual care arm
Arm Description
Receive the relational agent and the AliveCor Kardia for use for 120 days. Participants are directed to use these interventions daily.
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.
Outcomes
Primary Outcome Measures
Medication possession ratio
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
Self-reported adherence
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.
Change from baseline Atrial Fibrillation Effect on QualiTy of life (AFEQT) at 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.
Emergency room visits
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.
Urgent care visits
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.
Days of hospitalization
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.
Full Information
NCT ID
NCT04076020
First Posted
August 28, 2019
Last Updated
August 2, 2023
Sponsor
University of Pittsburgh
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Northeastern University, Boston University
1. Study Identification
Unique Protocol Identification Number
NCT04076020
Brief Title
Atrial Fibrillation Health Literacy and Information Technology Trial in Rural PA Counties
Acronym
AFibLITT_R
Official Title
Mobile Health Intervention for Rural Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 8, 2020 (Actual)
Primary Completion Date
May 27, 2023 (Actual)
Study Completion Date
August 2, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Northeastern University, Boston University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Familial Atrial Fibrillation, Arrhythmia, Cardiac, Heart Diseases, Pathologic Processes
Keywords
Adherence, Health Literacy, quality of life
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Telephone assessors conducting the 8- and 12-month assessments will be masked.
Allocation
Randomized
Enrollment
270 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Receive the relational agent and the AliveCor Kardia for use for 120 days. Participants are directed to use these interventions daily.
Arm Title
Usual care arm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Relational agent/AliveCor Kardia - Intervention Group
Intervention Description
Use of the relational agent and Kardia daily for 120 days.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Use of the WebMD app daily for 120 days.
Primary Outcome Measure Information:
Title
Medication possession ratio
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Self-reported adherence
Description
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.
Time Frame
4, 8 and 12 months
Title
Change from baseline Atrial Fibrillation Effect on QualiTy of life (AFEQT) at 4, 8 and 12 months
Description
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.
Time Frame
Baseline, 4, 8 and 12 months
Title
Emergency room visits
Description
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.
Time Frame
4, 8 and 12 months
Title
Urgent care visits
Description
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.
Time Frame
4, 8 and 12 months
Title
Days of hospitalization
Description
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.
Time Frame
4, 8 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult, age ≥18;
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);
CHA2DS2-VASc (heart failure, hypertension, age, diabetes, prior stroke/TIA, CD, female sex)≥2;
Prescribed use of warfarin or DOAC (formerly NOAC) 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.
Exclusion Criteria:
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 AV nodal ablation or foreseen AV nodal ablation;
Heart failure necessitating hospital admission ≤3 months prior to study inclusion;
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;
Untreated hyperthyroidism or ≤3 months euthyroidism before inclusion;
Foreseen pacemaker, internal cardioverter defibrillator, or cardiac resynchronization therapy;
Cardiac surgery ≤3 months before inclusion;
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jared W. Magnani, MD, MSc
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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).
IPD Sharing 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.
IPD Sharing 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.
Citations:
PubMed Identifier
33769555
Citation
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.
Results Reference
derived
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Atrial Fibrillation Health Literacy and Information Technology Trial in Rural PA Counties
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