Atrial Fibrillation Health Literacy and Information Technology Trial in Pittsburgh, PA (AFibLITT)
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|ClinicalTrials.gov Identifier: NCT04075994|
Recruitment Status : Active, not recruiting
First Posted : September 3, 2019
Last Update Posted : September 9, 2022
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Familial Atrial Fibrillation Arrythmia, Cardiac Heart Diseases Pathologic Processes||Behavioral: Relational Agent and heart rate and rhythm monitor Behavioral: Usual Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||A Mobile Relational Agent to Enhance Atrial Fibrillation Self-care|
|Actual Study Start Date :||January 2, 2020|
|Estimated Primary Completion Date :||September 1, 2023|
|Estimated Study Completion Date :||March 29, 2024|
Experimental: Intervention arm
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
Use of the Relational Agent and heart rate and rhythm monitor daily for 120 days.
Active Comparator: Usual care arm
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
Use of the WebMD app and heart rate and rhythm monitor daily for 120 days.
- 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.
- Self-reported adherence [ Time Frame: Baseline, 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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04075994
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Jared W Magnani, MD, MSc||University of Pittsburgh|