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

doi:10.1186/s13063-022-06578-1

. 2022 Sep 2;23(1):728.

doi: 10.1186/s13063-022-06578-1.

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

Simon Hatcher^#^{1

2

3}, Joel Werier^#^{4

5

6}, Nicole E Edgar^#⁴, James Booth⁷, D William J Cameron^{4

8}, Vicente Corrales-Medina⁴, Daniel Corsi⁹, Juthaporn Cowan^{4

10

11}, Pierre Giguère^{4

12

13}, Mark Kaluzienski^{14

15}, Shawn Marshall^{4

16

17}, Tiago Mestre^{18

19

20}, Bryce Mulligan^{21

22}, Heather Orpana²³, Amanda Pontefract^{4

21}, Darlene Stafford⁶, Kednapa Thavorn⁹, Guy Trudel^{24

25}

Affiliations

¹ Clinical Epidemiology Program, Ottawa Hospital Research Institute, 1919 Riverside Drive, Suite 406, Ottawa, ON, Canada. shatcher@toh.ca.
² Department of Psychiatry, University of Ottawa, 5457-1145 Carling Avenue, Ottawa, ON, Canada. shatcher@toh.ca.
³ Department of Mental Health, The Ottawa Hospital, 501 Smyth Road, Ottawa, ON, Canada. shatcher@toh.ca.
⁴ Clinical Epidemiology Program, Ottawa Hospital Research Institute, 1919 Riverside Drive, Suite 406, Ottawa, ON, Canada.
⁵ Department of Surgery, The Ottawa Hospital, 501 Smyth Road, Ottawa, ON, Canada.
⁶ Ontario Workers Network, The Ottawa Hospital, 501 Smyth Road, Ottawa, ON, Canada.
⁷ , Ottawa, Canada.
⁸ Division of Infectious Diseases, University of Ottawa, 451 Smyth Road, Ottawa, ON, Canada.
⁹ School of Epidemiology and Public Health, University of Ottawa, 600 Peter Morand Crescent, Ottawa, ON, Canada.
¹⁰ Department of Medicine, University of Ottawa, 501 Smyth Road, Ottawa, ON, Canada.
¹¹ Centre of Infection, Immunity, and Inflammation, University of Ottawa, 451 Smyth Road, Ottawa, ON, Canada.
¹² Department of Pharmacy, The Ottawa Hospital, 501 Smyth Road, Ottawa, ON, Canada.
¹³ School of Pharmaceutical Sciences, University of Ottawa, 451 Smyth Road, Ottawa, ON, Canada.
¹⁴ Department of Psychiatry, University of Ottawa, 5457-1145 Carling Avenue, Ottawa, ON, Canada.
¹⁵ Department of Mental Health, The Ottawa Hospital, 501 Smyth Road, Ottawa, ON, Canada.
¹⁶ Division of Physical Medicine and Rehabilitation, University of Ottawa, 505 Smyth Road, Ottawa, ON, Canada.
¹⁷ Bruyère Research Institute, 85 Primrose Avenue, Ottawa, ON, Canada.
¹⁸ Parkinson's Disease and Movement Disorders Center, Division of Neurology, Department of Medicine, University of Ottawa, 501 Smyth Road, Ottawa, ON, Canada.
¹⁹ Neuroscience Program, Ottawa Hospital Research Institute, 501 Smyth Road, Ottawa, ON, Canada.
²⁰ University of Ottawa Brain and Mind Research Institute, 451 Smyth Road, Ottawa, ON, Canada.
²¹ Department of Psychology, The Ottawa Hospital, 501 Smyth Road, Ottawa, ON, Canada.
²² School of Psychology, University of Ottawa, 136 Jean-Jacques Lussier Private, Ottawa, ON, Canada.
²³ Public Health Agency of Canada, 130 Colonnade Road, Ottawa, ON, Canada.
²⁴ Department of Medicine, The Ottawa Hospital, 501 Smyth Road, Ottawa, ON, Canada.
²⁵ Department of Biochemistry, Microbiology and Immunology, University of Ottawa, 451 Smyth Road, Ottawa, ON, Canada.

^# Contributed equally.

PMID: 36056372
PMCID: PMC9437413
DOI: 10.1186/s13063-022-06578-1

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

Simon Hatcher et al. Trials. 2022.

. 2022 Sep 2;23(1):728.

doi: 10.1186/s13063-022-06578-1.

Authors

Affiliations

¹ Clinical Epidemiology Program, Ottawa Hospital Research Institute, 1919 Riverside Drive, Suite 406, Ottawa, ON, Canada. shatcher@toh.ca.
² Department of Psychiatry, University of Ottawa, 5457-1145 Carling Avenue, Ottawa, ON, Canada. shatcher@toh.ca.
³ Department of Mental Health, The Ottawa Hospital, 501 Smyth Road, Ottawa, ON, Canada. shatcher@toh.ca.
⁴ Clinical Epidemiology Program, Ottawa Hospital Research Institute, 1919 Riverside Drive, Suite 406, Ottawa, ON, Canada.
⁵ Department of Surgery, The Ottawa Hospital, 501 Smyth Road, Ottawa, ON, Canada.
⁶ Ontario Workers Network, The Ottawa Hospital, 501 Smyth Road, Ottawa, ON, Canada.
⁷ , Ottawa, Canada.
⁸ Division of Infectious Diseases, University of Ottawa, 451 Smyth Road, Ottawa, ON, Canada.
⁹ School of Epidemiology and Public Health, University of Ottawa, 600 Peter Morand Crescent, Ottawa, ON, Canada.
¹⁰ Department of Medicine, University of Ottawa, 501 Smyth Road, Ottawa, ON, Canada.
¹¹ Centre of Infection, Immunity, and Inflammation, University of Ottawa, 451 Smyth Road, Ottawa, ON, Canada.
¹² Department of Pharmacy, The Ottawa Hospital, 501 Smyth Road, Ottawa, ON, Canada.
¹³ School of Pharmaceutical Sciences, University of Ottawa, 451 Smyth Road, Ottawa, ON, Canada.
¹⁴ Department of Psychiatry, University of Ottawa, 5457-1145 Carling Avenue, Ottawa, ON, Canada.
¹⁵ Department of Mental Health, The Ottawa Hospital, 501 Smyth Road, Ottawa, ON, Canada.
¹⁶ Division of Physical Medicine and Rehabilitation, University of Ottawa, 505 Smyth Road, Ottawa, ON, Canada.
¹⁷ Bruyère Research Institute, 85 Primrose Avenue, Ottawa, ON, Canada.
¹⁸ Parkinson's Disease and Movement Disorders Center, Division of Neurology, Department of Medicine, University of Ottawa, 501 Smyth Road, Ottawa, ON, Canada.
¹⁹ Neuroscience Program, Ottawa Hospital Research Institute, 501 Smyth Road, Ottawa, ON, Canada.
²⁰ University of Ottawa Brain and Mind Research Institute, 451 Smyth Road, Ottawa, ON, Canada.
²¹ Department of Psychology, The Ottawa Hospital, 501 Smyth Road, Ottawa, ON, Canada.
²² School of Psychology, University of Ottawa, 136 Jean-Jacques Lussier Private, Ottawa, ON, Canada.
²³ Public Health Agency of Canada, 130 Colonnade Road, Ottawa, ON, Canada.
²⁴ Department of Medicine, The Ottawa Hospital, 501 Smyth Road, Ottawa, ON, Canada.
²⁵ Department of Biochemistry, Microbiology and Immunology, University of Ottawa, 451 Smyth Road, Ottawa, ON, Canada.

^# Contributed equally.

PMID: 36056372
PMCID: PMC9437413
DOI: 10.1186/s13063-022-06578-1

Abstract

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.

Keywords: Blended care; COVID-19; SARS-CoV-2; Long COVID; Electronic case management; Post-COVID rehabilitation.

PubMed Disclaimer

Conflict of interest statement

MK has consulting or speaking fees, unrelated to this trial or intervention, from HLS, Janssen, Otsuka, and Lundbeck in the last 2 years. TM, unrelated to this trial or intervention, has been a consultant for CHDI, Sunovion, Valeo Pharma, Roche, Biogen, and nQ Medical and has been involved in Speakers Bureaus for Abbvie and Valeo Pharma.

The other authors declare that they have no competing interests.

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Cited by

Interventions for mental health, cognition, and psychological wellbeing in long COVID: a systematic review of registered trials.
Hawke LD, Nguyen ATP, Ski CF, Thompson DR, Ma C, Castle D. Hawke LD, et al. Psychol Med. 2022 Oct;52(13):2426-2440. doi: 10.1017/S0033291722002203. Epub 2022 Jun 30. Psychol Med. 2022. PMID: 35768406 Free PMC article.

References

1. Government of Ontario . All Ontario: case numbers and spread. 2021.
1. Mahmud R, Rahman M, Rassel M, Monayem F, Sayeed S, Islam M, et al. Post-COVID-19 syndrome among symptomatic COVID-19 patients: a prospective cohort study in a tertiary care center of Bangladesh. PLoS One. 2021;16(4):e0249644. - PMC - PubMed
1. Nehme M, Braillard O, Alcoba G, Aebischer Perone S, Courvoisier D, Chappuis F, et al. COVID-19 symptoms: longitudinal evolution and persistence in outpatient settings. Ann Intern Med. 2020;174(5):723–725. doi: 10.7326/M20-5926. - DOI - PMC - PubMed
1. Huang C, Huang L, Wang Y, Li X, Ren L, Gu X, et al. 6-month consequences of COVID-19 in patients discharged from hospital: a cohort study. Lancet. 2021;397(10270):220–232. doi: 10.1016/S0140-6736(20)32656-8. - DOI - PMC - PubMed
1. Salmon-Ceron D, Slama D, De Broucker T, Karmochkine M, Pavie J, Sorbets E, et al. Clinical, virological and imaging profile in patients with prolonged forms of COVID-19: a cross-sectional study. J Infect. 2021;82(2):e1–e4. doi: 10.1016/j.jinf.2020.12.002. - DOI - PMC - PubMed

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[1] Government of Ontario . All Ontario: case numbers and spread. 2021.

[2] Government of Ontario . All Ontario: case numbers and spread. 2021.

[3] Mahmud R, Rahman M, Rassel M, Monayem F, Sayeed S, Islam M, et al. Post-COVID-19 syndrome among symptomatic COVID-19 patients: a prospective cohort study in a tertiary care center of Bangladesh. PLoS One. 2021;16(4):e0249644. - PMC - PubMed

[4] Mahmud R, Rahman M, Rassel M, Monayem F, Sayeed S, Islam M, et al. Post-COVID-19 syndrome among symptomatic COVID-19 patients: a prospective cohort study in a tertiary care center of Bangladesh. PLoS One. 2021;16(4):e0249644. - PMC - PubMed

[5] Nehme M, Braillard O, Alcoba G, Aebischer Perone S, Courvoisier D, Chappuis F, et al. COVID-19 symptoms: longitudinal evolution and persistence in outpatient settings. Ann Intern Med. 2020;174(5):723–725. doi: 10.7326/M20-5926. - DOI - PMC - PubMed

[6] Nehme M, Braillard O, Alcoba G, Aebischer Perone S, Courvoisier D, Chappuis F, et al. COVID-19 symptoms: longitudinal evolution and persistence in outpatient settings. Ann Intern Med. 2020;174(5):723–725. doi: 10.7326/M20-5926. - DOI - PMC - PubMed

[7] Huang C, Huang L, Wang Y, Li X, Ren L, Gu X, et al. 6-month consequences of COVID-19 in patients discharged from hospital: a cohort study. Lancet. 2021;397(10270):220–232. doi: 10.1016/S0140-6736(20)32656-8. - DOI - PMC - PubMed

[8] Huang C, Huang L, Wang Y, Li X, Ren L, Gu X, et al. 6-month consequences of COVID-19 in patients discharged from hospital: a cohort study. Lancet. 2021;397(10270):220–232. doi: 10.1016/S0140-6736(20)32656-8. - DOI - PMC - PubMed

[9] Salmon-Ceron D, Slama D, De Broucker T, Karmochkine M, Pavie J, Sorbets E, et al. Clinical, virological and imaging profile in patients with prolonged forms of COVID-19: a cross-sectional study. J Infect. 2021;82(2):e1–e4. doi: 10.1016/j.jinf.2020.12.002. - DOI - PMC - PubMed

[10] Salmon-Ceron D, Slama D, De Broucker T, Karmochkine M, Pavie J, Sorbets E, et al. Clinical, virological and imaging profile in patients with prolonged forms of COVID-19: a cross-sectional study. J Infect. 2021;82(2):e1–e4. doi: 10.1016/j.jinf.2020.12.002. - DOI - PMC - PubMed

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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

Affiliations

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

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Abstract

Conflict of interest statement

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