Rurality and atrial fibrillation: A pathway to virtual engagement and clinical trial recruitment in response to COVID-19

Study objective: To summarize trial adaptation from in-clinic to virtual design in response to the SARS-2 coronavirus-2 (COVID-19). Design: A clinical trial of a mobile health intervention to improve chronic disease self-management for rural individuals with atrial fibrillation (AF). The trial has a...

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Main Authors: Jared W. Magnani, Danielle Ferry, Gretchen Swabe, Deborah Martin, Xirun Chen, Maria M. Brooks, Samar R. El Khoudary
Format: Article
Language:English
Published: Elsevier 2021-03-01
Series:American Heart Journal Plus
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S266660222100015X
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author Jared W. Magnani
Danielle Ferry
Gretchen Swabe
Deborah Martin
Xirun Chen
Maria M. Brooks
Samar R. El Khoudary
author_facet Jared W. Magnani
Danielle Ferry
Gretchen Swabe
Deborah Martin
Xirun Chen
Maria M. Brooks
Samar R. El Khoudary
author_sort Jared W. Magnani
collection DOAJ
description Study objective: To summarize trial adaptation from in-clinic to virtual design in response to the SARS-2 coronavirus-2 (COVID-19). Design: A clinical trial of a mobile health intervention to improve chronic disease self-management for rural individuals with atrial fibrillation (AF). The trial has a 4-month intervention – accessible regardless of health or digital literacy – to enhance AF medication adherence and patient experience with 8- and 12-month assessments of sustainability. Setting: Rural, western Pennsylvania. Participants: Rural individuals with AF receiving oral anticoagulation for stroke prevention. Interventions: Enrolled participants underwent a telephone-based orientation, provided verbal consent, and were randomized using a digital platform. They received a smartphone with intervention or control applications and a curriculum on usage tailored for study arm. Participants received study assessments by mail with telephone-based administration and contact for the 12-month trial. Main outcome measures: Successful adaptation to virtual engagement and recruitment. Results: The study enrolled 18 participants during in-clinic recruitment (January–March 2020). From 5/1/2020 to 5/6/2021 the study team enrolled 130 individuals (median age 72.4 years, range 40.8–92.2; 49.2% women, 63.1% without college degree, and 45.4% with limited health literacy). Retention of participants enrolled using virtual methods during the 4-month intervention phase is 92%. Conclusions: We report a virtual trial of a mobile health intervention for rural individuals with AF. Our successful implementation suggests promise for engaging geographically isolated rural individuals, potential to enhance digital health access, and advance rural health equity.
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spelling doaj.art-9e01706ff5d143e79b22146a5152d27e2022-12-21T21:18:44ZengElsevierAmerican Heart Journal Plus2666-60222021-03-013100017Rurality and atrial fibrillation: A pathway to virtual engagement and clinical trial recruitment in response to COVID-19Jared W. Magnani0Danielle Ferry1Gretchen Swabe2Deborah Martin3Xirun Chen4Maria M. Brooks5Samar R. El Khoudary6Department of Medicine, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Epidemiology, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA, United States of America; Corresponding author at: University of Pittsburgh, 3609 Forbes Avenue, Second Floor, Pittsburgh, PA 15213, United States of America.Department of Medicine, University of Pittsburgh, Pittsburgh, PA, United States of AmericaDepartment of Medicine, University of Pittsburgh, Pittsburgh, PA, United States of AmericaDepartment of Epidemiology, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA, United States of AmericaDepartment of Epidemiology, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA, United States of AmericaDepartment of Epidemiology, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA, United States of AmericaDepartment of Epidemiology, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA, United States of AmericaStudy objective: To summarize trial adaptation from in-clinic to virtual design in response to the SARS-2 coronavirus-2 (COVID-19). Design: A clinical trial of a mobile health intervention to improve chronic disease self-management for rural individuals with atrial fibrillation (AF). The trial has a 4-month intervention – accessible regardless of health or digital literacy – to enhance AF medication adherence and patient experience with 8- and 12-month assessments of sustainability. Setting: Rural, western Pennsylvania. Participants: Rural individuals with AF receiving oral anticoagulation for stroke prevention. Interventions: Enrolled participants underwent a telephone-based orientation, provided verbal consent, and were randomized using a digital platform. They received a smartphone with intervention or control applications and a curriculum on usage tailored for study arm. Participants received study assessments by mail with telephone-based administration and contact for the 12-month trial. Main outcome measures: Successful adaptation to virtual engagement and recruitment. Results: The study enrolled 18 participants during in-clinic recruitment (January–March 2020). From 5/1/2020 to 5/6/2021 the study team enrolled 130 individuals (median age 72.4 years, range 40.8–92.2; 49.2% women, 63.1% without college degree, and 45.4% with limited health literacy). Retention of participants enrolled using virtual methods during the 4-month intervention phase is 92%. Conclusions: We report a virtual trial of a mobile health intervention for rural individuals with AF. Our successful implementation suggests promise for engaging geographically isolated rural individuals, potential to enhance digital health access, and advance rural health equity.http://www.sciencedirect.com/science/article/pii/S266660222100015XAtrial fibrillationDigital healthRuralitySelf-managementHealth literacy
spellingShingle Jared W. Magnani
Danielle Ferry
Gretchen Swabe
Deborah Martin
Xirun Chen
Maria M. Brooks
Samar R. El Khoudary
Rurality and atrial fibrillation: A pathway to virtual engagement and clinical trial recruitment in response to COVID-19
American Heart Journal Plus
Atrial fibrillation
Digital health
Rurality
Self-management
Health literacy
title Rurality and atrial fibrillation: A pathway to virtual engagement and clinical trial recruitment in response to COVID-19
title_full Rurality and atrial fibrillation: A pathway to virtual engagement and clinical trial recruitment in response to COVID-19
title_fullStr Rurality and atrial fibrillation: A pathway to virtual engagement and clinical trial recruitment in response to COVID-19
title_full_unstemmed Rurality and atrial fibrillation: A pathway to virtual engagement and clinical trial recruitment in response to COVID-19
title_short Rurality and atrial fibrillation: A pathway to virtual engagement and clinical trial recruitment in response to COVID-19
title_sort rurality and atrial fibrillation a pathway to virtual engagement and clinical trial recruitment in response to covid 19
topic Atrial fibrillation
Digital health
Rurality
Self-management
Health literacy
url http://www.sciencedirect.com/science/article/pii/S266660222100015X
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