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Enhancing COVID Rehabilitation with Technology (ECORT): protocol for an open-label, single-site randomized controlled trial evaluating the effectiveness of electronic case management for individuals with persistent COVID-19 symptoms

BACKGROUND: As of May 2022, Ontario has seen more than 1.3 million cases of COVID-19. While the majority of individuals will recover from infection within 4 weeks, a significant subset experience persistent and often debilitating symptoms, known as “post-COVID syndrome” or “Long COVID.” Those with L...

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Autores principales: Hatcher, Simon, Werier, Joel, Edgar, Nicole E., Booth, James, Cameron, D. William J., Corrales-Medina, Vicente, Corsi, Daniel, Cowan, Juthaporn, Giguère, Pierre, Kaluzienski, Mark, Marshall, Shawn, Mestre, Tiago, Mulligan, Bryce, Orpana, Heather, Pontefract, Amanda, Stafford, Darlene, Thavorn, Kednapa, Trudel, Guy
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9437413/
https://www.ncbi.nlm.nih.gov/pubmed/36056372
http://dx.doi.org/10.1186/s13063-022-06578-1
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author Hatcher, Simon
Werier, Joel
Edgar, Nicole E.
Booth, James
Cameron, D. William J.
Corrales-Medina, Vicente
Corsi, Daniel
Cowan, Juthaporn
Giguère, Pierre
Kaluzienski, Mark
Marshall, Shawn
Mestre, Tiago
Mulligan, Bryce
Orpana, Heather
Pontefract, Amanda
Stafford, Darlene
Thavorn, Kednapa
Trudel, Guy
author_facet Hatcher, Simon
Werier, Joel
Edgar, Nicole E.
Booth, James
Cameron, D. William J.
Corrales-Medina, Vicente
Corsi, Daniel
Cowan, Juthaporn
Giguère, Pierre
Kaluzienski, Mark
Marshall, Shawn
Mestre, Tiago
Mulligan, Bryce
Orpana, Heather
Pontefract, Amanda
Stafford, Darlene
Thavorn, Kednapa
Trudel, Guy
author_sort Hatcher, Simon
collection PubMed
description BACKGROUND: As of May 2022, Ontario has seen more than 1.3 million cases of COVID-19. While the majority of individuals will recover from infection within 4 weeks, a significant subset experience persistent and often debilitating symptoms, known as “post-COVID syndrome” or “Long COVID.” Those with Long COVID experience a wide array of symptoms, with variable severity, including fatigue, cognitive impairment, and shortness of breath. Further, the prevalence and duration of Long COVID is not clear, nor is there evidence on the best course of rehabilitation for individuals to return to their desired level of function. Previous work with chronic conditions has suggested that the addition of electronic case management (ECM) may help to improve outcomes. These platforms provide enhanced connection with care providers, detailed symptom tracking and goal setting, and access to relevant resources. In this study, our primary aim is to determine if the addition of ECM with health coaching improves Long COVID outcomes at 3 months compared to health coaching alone. METHODS: The trial is an open-label, single-site, randomized controlled trial of ECM with health coaching (ECM+) compared to health coaching alone (HC). Both groups will continue to receive usual care. Participants will be randomized equally to receive health coaching (± ECM) for a period of 8 weeks and a 12-week follow-up. Our primary outcome is the WHO Disability Assessment Scale (WHODAS), 36-item self-report total score. Participants will also complete measures of cognition, fatigue, breathlessness, and mental health. Participants and care providers will be asked to complete a brief qualitative interview at the end of the study to evaluate acceptability and implementation of the intervention. DISCUSSION: There is currently little evidence about the optimal treatment of Long COVID patients or the use of digital health platforms in this population. The results of this trial could result in rapid, scalable, and personalized care for people with Long COVID which will decrease morbidity after an acute infection. Results from this study will also inform decision making in Long COVID and treatment guidelines at provincial and national levels. TRIAL REGISTRATION: ClinicalTrials.gov NCT05019963. Registered on 25 August 2021.
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spelling pubmed-94374132022-09-02 Enhancing COVID Rehabilitation with Technology (ECORT): protocol for an open-label, single-site randomized controlled trial evaluating the effectiveness of electronic case management for individuals with persistent COVID-19 symptoms Hatcher, Simon Werier, Joel Edgar, Nicole E. Booth, James Cameron, D. William J. Corrales-Medina, Vicente Corsi, Daniel Cowan, Juthaporn Giguère, Pierre Kaluzienski, Mark Marshall, Shawn Mestre, Tiago Mulligan, Bryce Orpana, Heather Pontefract, Amanda Stafford, Darlene Thavorn, Kednapa Trudel, Guy Trials Study Protocol BACKGROUND: As of May 2022, Ontario has seen more than 1.3 million cases of COVID-19. While the majority of individuals will recover from infection within 4 weeks, a significant subset experience persistent and often debilitating symptoms, known as “post-COVID syndrome” or “Long COVID.” Those with Long COVID experience a wide array of symptoms, with variable severity, including fatigue, cognitive impairment, and shortness of breath. Further, the prevalence and duration of Long COVID is not clear, nor is there evidence on the best course of rehabilitation for individuals to return to their desired level of function. Previous work with chronic conditions has suggested that the addition of electronic case management (ECM) may help to improve outcomes. These platforms provide enhanced connection with care providers, detailed symptom tracking and goal setting, and access to relevant resources. In this study, our primary aim is to determine if the addition of ECM with health coaching improves Long COVID outcomes at 3 months compared to health coaching alone. METHODS: The trial is an open-label, single-site, randomized controlled trial of ECM with health coaching (ECM+) compared to health coaching alone (HC). Both groups will continue to receive usual care. Participants will be randomized equally to receive health coaching (± ECM) for a period of 8 weeks and a 12-week follow-up. Our primary outcome is the WHO Disability Assessment Scale (WHODAS), 36-item self-report total score. Participants will also complete measures of cognition, fatigue, breathlessness, and mental health. Participants and care providers will be asked to complete a brief qualitative interview at the end of the study to evaluate acceptability and implementation of the intervention. DISCUSSION: There is currently little evidence about the optimal treatment of Long COVID patients or the use of digital health platforms in this population. The results of this trial could result in rapid, scalable, and personalized care for people with Long COVID which will decrease morbidity after an acute infection. Results from this study will also inform decision making in Long COVID and treatment guidelines at provincial and national levels. TRIAL REGISTRATION: ClinicalTrials.gov NCT05019963. Registered on 25 August 2021. BioMed Central 2022-09-02 /pmc/articles/PMC9437413/ /pubmed/36056372 http://dx.doi.org/10.1186/s13063-022-06578-1 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Hatcher, Simon
Werier, Joel
Edgar, Nicole E.
Booth, James
Cameron, D. William J.
Corrales-Medina, Vicente
Corsi, Daniel
Cowan, Juthaporn
Giguère, Pierre
Kaluzienski, Mark
Marshall, Shawn
Mestre, Tiago
Mulligan, Bryce
Orpana, Heather
Pontefract, Amanda
Stafford, Darlene
Thavorn, Kednapa
Trudel, Guy
Enhancing COVID Rehabilitation with Technology (ECORT): protocol for an open-label, single-site randomized controlled trial evaluating the effectiveness of electronic case management for individuals with persistent COVID-19 symptoms
title Enhancing COVID Rehabilitation with Technology (ECORT): protocol for an open-label, single-site randomized controlled trial evaluating the effectiveness of electronic case management for individuals with persistent COVID-19 symptoms
title_full Enhancing COVID Rehabilitation with Technology (ECORT): protocol for an open-label, single-site randomized controlled trial evaluating the effectiveness of electronic case management for individuals with persistent COVID-19 symptoms
title_fullStr Enhancing COVID Rehabilitation with Technology (ECORT): protocol for an open-label, single-site randomized controlled trial evaluating the effectiveness of electronic case management for individuals with persistent COVID-19 symptoms
title_full_unstemmed Enhancing COVID Rehabilitation with Technology (ECORT): protocol for an open-label, single-site randomized controlled trial evaluating the effectiveness of electronic case management for individuals with persistent COVID-19 symptoms
title_short Enhancing COVID Rehabilitation with Technology (ECORT): protocol for an open-label, single-site randomized controlled trial evaluating the effectiveness of electronic case management for individuals with persistent COVID-19 symptoms
title_sort enhancing covid rehabilitation with technology (ecort): protocol for an open-label, single-site randomized controlled trial evaluating the effectiveness of electronic case management for individuals with persistent covid-19 symptoms
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9437413/
https://www.ncbi.nlm.nih.gov/pubmed/36056372
http://dx.doi.org/10.1186/s13063-022-06578-1
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