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.

Antiviral Agents / adverse effects COVID-19 / complications Case Management Electronics Fatigue / chemically induced Humans Randomized Controlled Trials as Topic SARS-CoV-2 Technology Treatment Outcome Post-Acute COVID-19 Syndrome
Blended care COVID-19; SARS-CoV-2; Long COVID Electronic case management Post-COVID rehabilitation

Journal

Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253

Informations de publication

Date de publication:
02 Sep 2022
Historique:
received: 03 06 2022
accepted: 20 07 2022
entrez: 2 9 2022
pubmed: 3 9 2022
medline: 8 9 2022
Statut: epublish

Résumé

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. 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. 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. ClinicalTrials.gov NCT05019963. Registered on 25 August 2021.

Sections du résumé

BACKGROUND 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 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 CONCLUSIONS
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 BACKGROUND
ClinicalTrials.gov NCT05019963. Registered on 25 August 2021.

Identifiants

DOI: 10.1186/s13063-022-06578-1 PMID: 36056372 PMC: PMC9437413
pubmed: 36056372
doi: 10.1186/s13063-022-06578-1
pii: 10.1186/s13063-022-06578-1
pmc: PMC9437413
doi:

Substances chimiques

Antiviral Agents 0

Banques de données

ClinicalTrials.gov
['NCT05019963']

Types de publication

Clinical Trial Protocol Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

728

Subventions

Organisme : CIHR
ID : 466900
Pays : Canada

Informations de copyright

© 2022. The Author(s).

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Auteurs

Simon Hatcher (S)

Clinical Epidemiology Program, Ottawa Hospital Research Institute, 1919 Riverside Drive, Suite 406, Ottawa, ON, Canada. shatcher@toh.ca.
Department of Psychiatry, University of Ottawa, 5457-1145 Carling Avenue, Ottawa, ON, Canada. shatcher@toh.ca.
Department of Mental Health, The Ottawa Hospital, 501 Smyth Road, Ottawa, ON, Canada. shatcher@toh.ca.
ORCID: 0000-0003-3117-2350

Joel Werier (J)

Clinical Epidemiology Program, Ottawa Hospital Research Institute, 1919 Riverside Drive, Suite 406, Ottawa, ON, Canada.
Department of Surgery, The Ottawa Hospital, 501 Smyth Road, Ottawa, ON, Canada.
Ontario Workers Network, The Ottawa Hospital, 501 Smyth Road, Ottawa, ON, Canada.

Nicole E Edgar (NE)

Clinical Epidemiology Program, Ottawa Hospital Research Institute, 1919 Riverside Drive, Suite 406, Ottawa, ON, Canada.

James Booth (J)

, Ottawa, Canada.

D William J Cameron (DWJ)

Clinical Epidemiology Program, Ottawa Hospital Research Institute, 1919 Riverside Drive, Suite 406, Ottawa, ON, Canada.
Division of Infectious Diseases, University of Ottawa, 451 Smyth Road, Ottawa, ON, Canada.

Vicente Corrales-Medina (V)

Clinical Epidemiology Program, Ottawa Hospital Research Institute, 1919 Riverside Drive, Suite 406, Ottawa, ON, Canada.

Daniel Corsi (D)

School of Epidemiology and Public Health, University of Ottawa, 600 Peter Morand Crescent, Ottawa, ON, Canada.

Juthaporn Cowan (J)

Clinical Epidemiology Program, Ottawa Hospital Research Institute, 1919 Riverside Drive, Suite 406, Ottawa, ON, Canada.
Department of Medicine, University of Ottawa, 501 Smyth Road, Ottawa, ON, Canada.
Centre of Infection, Immunity, and Inflammation, University of Ottawa, 451 Smyth Road, Ottawa, ON, Canada.

Pierre Giguère (P)

Clinical Epidemiology Program, Ottawa Hospital Research Institute, 1919 Riverside Drive, Suite 406, Ottawa, ON, Canada.
Department of Pharmacy, The Ottawa Hospital, 501 Smyth Road, Ottawa, ON, Canada.
School of Pharmaceutical Sciences, University of Ottawa, 451 Smyth Road, Ottawa, ON, Canada.

Mark Kaluzienski (M)

Department of Psychiatry, University of Ottawa, 5457-1145 Carling Avenue, Ottawa, ON, Canada.
Department of Mental Health, The Ottawa Hospital, 501 Smyth Road, Ottawa, ON, Canada.

Shawn Marshall (S)

Clinical Epidemiology Program, Ottawa Hospital Research Institute, 1919 Riverside Drive, Suite 406, Ottawa, ON, Canada.
Division of Physical Medicine and Rehabilitation, University of Ottawa, 505 Smyth Road, Ottawa, ON, Canada.
Bruyère Research Institute, 85 Primrose Avenue, Ottawa, ON, Canada.

Tiago Mestre (T)

Parkinson's Disease and Movement Disorders Center, Division of Neurology, Department of Medicine, University of Ottawa, 501 Smyth Road, Ottawa, ON, Canada.
Neuroscience Program, Ottawa Hospital Research Institute, 501 Smyth Road, Ottawa, ON, Canada.
University of Ottawa Brain and Mind Research Institute, 451 Smyth Road, Ottawa, ON, Canada.

Bryce Mulligan (B)

Department of Psychology, The Ottawa Hospital, 501 Smyth Road, Ottawa, ON, Canada.
School of Psychology, University of Ottawa, 136 Jean-Jacques Lussier Private, Ottawa, ON, Canada.

Heather Orpana (H)

Public Health Agency of Canada, 130 Colonnade Road, Ottawa, ON, Canada.

Amanda Pontefract (A)

Clinical Epidemiology Program, Ottawa Hospital Research Institute, 1919 Riverside Drive, Suite 406, Ottawa, ON, Canada.
Department of Psychology, The Ottawa Hospital, 501 Smyth Road, Ottawa, ON, Canada.

Darlene Stafford (D)

Ontario Workers Network, The Ottawa Hospital, 501 Smyth Road, Ottawa, ON, Canada.

Kednapa Thavorn (K)

School of Epidemiology and Public Health, University of Ottawa, 600 Peter Morand Crescent, Ottawa, ON, Canada.

Guy Trudel (G)

Department of Medicine, The Ottawa Hospital, 501 Smyth Road, Ottawa, ON, Canada.
Department of Biochemistry, Microbiology and Immunology, University of Ottawa, 451 Smyth Road, Ottawa, ON, Canada.

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Classifications MeSH

questionsmedicales.fr › Actions chimiques et utilisations › Actions pharmacologiques › Utilisations thérapeutiques › Anti-infectieux › Antiviraux › Enhancing COVID Rehabilitation with Technology...
questionsmedicales.fr › Maladies de l'appareil respiratoire › Infections de l'appareil respiratoire › Pneumopathie infectieuse › Pneumopathie virale › COVID-19 › Enhancing COVID Rehabilitation with Technology...
questionsmedicales.fr › Administration des services de santé › Gestion des soins aux patients › Services de santé polyvalents › Planification des soins du patient › Prise en charge personnalisée du patient › Enhancing COVID Rehabilitation with Technology...
questionsmedicales.fr › Disciplines des sciences naturelles › Physique › Électronique › Enhancing COVID Rehabilitation with Technology...
questionsmedicales.fr › États, signes et symptômes pathologiques › Signes et symptômes › Fatigue › Enhancing COVID Rehabilitation with Technology...
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questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Qualité des soins de santé › Mécanismes d'évaluation des soins de santé › Évaluation des résultats et des processus en soins de santé › Évaluation de résultat (soins) › Résultat thérapeutique › Enhancing COVID Rehabilitation with Technology...
questionsmedicales.fr › États, signes et symptômes pathologiques › Processus pathologiques › Caractéristiques de la maladie › Maladie chronique › Troubles post-infectieux › Syndrome de post-COVID-19 › Enhancing COVID Rehabilitation with Technology...