Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2022

Open Access 01-12-2022 | Long-COVID Syndrome | Study protocol

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

Authors: Simon Hatcher, Joel Werier, Nicole E. Edgar, James Booth, D. William J. Cameron, Vicente Corrales-Medina, Daniel Corsi, Juthaporn Cowan, Pierre Giguère, Mark Kaluzienski, Shawn Marshall, Tiago Mestre, Bryce Mulligan, Heather Orpana, Amanda Pontefract, Darlene Stafford, Kednapa Thavorn, Guy Trudel

Published in: Trials | Issue 1/2022

Login to get access

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.
Literature
1.
2.
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.
3.
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):723–5.PubMedCrossRef
4.
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):220–32.PubMedPubMedCentralCrossRef
5.
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):e1–4.PubMedCrossRef
6.
7.
8.
Davis H, Assaf G, McCorkell L, Wei H, Low R, Re’em Y, et al. Characterizing long COVID in an international cohort: 7 months of symptoms and their impact. EClinicalMedicine. 2021;38:101019.PubMedPubMedCentralCrossRef
9.
Taquet M, Geddes JR, Husain M, Luciano S, Harrison PJ. 6-month neurological and psychiatric outcomes in 236 379 survivors of COVID-19: A retrospective cohort study using electronic health records. Lancet Psychiatry. 2021;S2215-0366(21):00084–5 [cited 2021 Apr 12]. Available from: http://​www.​ncbi.​nlm.​nih.​gov/​pubmed/​33836148.
10.
Tenforde MW, Kim SS, Lindsell CJ, Billig Rose E, Shapiro NI, Files DC, et al. Symptom duration and risk factors for delayed return to usual health among outpatients with COVID-19 in a multistate health vare systems network — United States, March–June 2020. Morb Mortal Wkly Rep. 2020;69(30):993–8.CrossRef
11.
Ayoubkhani D, Khunti K, Nafilyan V, Maddox T, Humberstone B, Diamond I, et al. Post-covid syndrome in individuals admitted to hospital with covid-19: retrospective cohort study. BMJ. 2021;372:n693.
12.
Lam MHB, Wing YK, Yu MWM, Leung CM, Ma RCW, Kong APS, et al. Mental morbidities and chronic fatigue in severe acute respiratory syndrome survivors long-term follow-up. Arch Intern Med. 2009;169(22):2142–7.PubMedCrossRef
13.
Gilmutdinova IR, Kolyshenkov VA, Lapickaya KA, Trepova AS, Vasileva VA, Prosvirnin AN, et al. Telemedicine platform COVIDREHAB for remote rehabilitation of patients after COVID-19. Eur J Transl Myol. 2021;31(2):9783.PubMedCentralCrossRef
14.
Yan Z, Yang M, Lai CL. Long covid-19 syndrome: a comprehensive review of its effect on various organ systems and recommendation on rehabilitation plans. Biomedicines. 2021;9(8):966.PubMedPubMedCentralCrossRef
15.
16.
Hamine S, Gerth-Guyette E, Faulx D, Green BB, Ginsburg AS. Impact of mHealth chronic disease management on treatment adherence and patient outcomes: a systematic review. J Med Internet Res. 2015;17(2):e52.PubMedPubMedCentralCrossRef
17.
Epstein E, Patel N, Maysent K, Taub PR. Cardiac rehab in the COVID era and beyond: mHealth and other novel opportunities. Curr Cardiol Rep. 2021;23(5):42.PubMedPubMedCentralCrossRef
18.
Archer J, Bower P, Gilbody S, Lovell K, Richards D, Gask L, et al. Collaborative care for depression and anxiety problems. Cochrane Database ofSystematic Rev. 2012;10(10):CD006525.
19.
Dejonghe LAL, Becker J, Froboese I, Schaller A. Long-term effectiveness of health coaching in rehabilitation and prevention: a systematic review. Patient Educ Couns. 2017;100(9):1643–53.PubMedCrossRef
20.
Wayne N, Ritvo P. Smartphone-enabled health coach intervention for people with diabetes from a modest socioeconomic strata community: single-arm longitudinal feasibility study. J Med Internet Res. 2014;16(6):e149.
21.
Wayne N, Perez DF, Kaplan DM, Ritvo P. Health coaching reduces HbA1c in type 2 diabetic patients from a lower-socioeconomic status community: a randomized controlled trial. J Med Internet Res. 2015;17(10):e224.PubMedPubMedCentralCrossRef
22.
Pludwinski S, Ahmad F, Wayne N, Ritvo P. Participant experiences in a smartphone-based health coaching intervention for type 2 diabetes: a qualitative inquiry. J Telemed Telecare. 2016;22(3):172–8.PubMedCrossRef
23.
MacLean S, Corsi DJ, Litchfield S, Kucharski J, Genise K, Selaman Z, et al. Coach-facilitated web-based therapy compared with information about web-based resources in patients referred to secondary mental health care for depression: randomized controlled trial. J Med Internet Res. 2020;22(6):e15001.PubMedPubMedCentralCrossRef
24.
Ritvo P, Knyahnytska Y, Pirbaglou M, Wang W, Tomlinson G, Zhao H, et al. Online mindfulness-based cognitive behavioral therapy intervention for youth with major depressive disorders: randomized controlled trial. J Med Internet Res. 2021;23(3):e24380.PubMedPubMedCentralCrossRef
25.
Hatcher S, Heisel M, Ayonrinde O, Campbell JK, Colman I, Corsi DJ, et al. The BEACON study: protocol for a cohort study as part of an evaluation of the effectiveness of smartphone-assisted problem-solving therapy in men who present with intentional self-harm to emergency departments in Ontario. Trials. 2020;21(1):925.PubMedPubMedCentralCrossRef
26.
Alibhai SMH, Santa Mina D, Ritvo P, Sabiston C, Krahn M, Tomlinson G, et al. A phase II RCT and economic analysis of three exercise delivery methods in men with prostate cancer on androgen deprivation therapy. BMC Cancer. 2015;15(1):312.PubMedPubMedCentralCrossRef
27.
Ritvo P, Obadia M, Santa Mina D, Alibhai S, Sabiston C, Oh P, et al. Smartphone-enabled health coaching intervention (iMOVE) to promote long-term maintenance of physical activity in breast cancer survivors: protocol for a feasibility pilot randomized controlled trial. JMIR Res Protoc. 2017;6(8):e165.PubMedPubMedCentralCrossRef
28.
Mackie C, Dunn N, Maclean S, Testa V, Heisel M, Hatcher S. A qualitative study of a blended therapy using problem solving therapy with a customised smartphone app in men who present to hospital with intentional self-harm. Evid Based Ment Health. 2017;20(4):118–22.PubMedCrossRef
29.
Curran D, Lauzon J, Quon DMS. Feasibility of an interactive coaching app to enhance post-concussion outpatient care. Front Med Technol. 2021;3:17.
30.
31.
Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999;89(9):1322–7.
32.
Üstün TB, World Health Organization. Measuring health and disability: Manual for WHO Disability Assessment Schedule WHODAS 2.0. Geneva: World Health Organization; 2010.
33.
34.
Saurman J, Vickers K, Rodriguez A, Andrews M, Gradone A, Jean K, et al. The utility of the Oral Trail Making Test in telehealth assessments with cognitively impaired older adults. Alzheimers Dement. 2021;17:e054781.CrossRef
35.
Abraham E, Axelrod BN, Ricker JH. Application of the oral trail making test to a mixed clinical sample. Arch Clin Neuropsychol. 1996;11(8):697–701.CrossRef
36.
Ashendorf L, Jefferson AL, O’Connor MK, Chaisson C, Green RC, Stern RA. Trail Making Test errors in normal age, mild cognitive impairment and dementia. Arch Clin Neuropsychol. 2008;23(2):129–37.PubMed
37.
Brandt J. 1. BJTHVLTD of a new memory test with six equivalent forms. CN 1991; The Hopkins Verbal Learning Test: development of a new memory test with six equivalent forms. Clin Neuropsychol. 1991;5(2):125–42.
38.
Strauss EA, Spreen O. Compendium of neuropsychological tests. Administration, norms, and commentary. 3rd ed. Oxford: Ocford University Press; 2006.
39.
Weiss LG, Saklofske DH, Coalson DL, Raiford SE. WAIS-IV clinical use and interpretation: scientist-practitioner perspectives. San Diego: Elsevier Science & Technology; 2010.
40.
Waters GS, Caplan D. The reliability and stability of verbal working memory measures. Behav Res Methods Instrum Comput. 2003;35(4):550–64.PubMedCrossRef
41.
Sumerall SW, Timmons PL, James AL, Ewing MJM, Oehlert ME. Expanded norms for the controlled oral word association test. J Clin Psychol. 1997;53(5):517–21.PubMedCrossRef
42.
Tombaugh TN, Kozak J, Rees L. Normative data stratified by age and education for two measures of verbal fluency: FAS and animal naming. Arch Clin Neuropsychol. 1999;14(2):167–77.PubMed
43.
Wittkampf KA, Naeije L, Schene AH, Huyser J, van Weert HC. Diagnostic accuracy of the mood module of the Patient Health Questionnaire: a systematic review. Gen Hosp Psychiatry. 2007;29(5):388–95.PubMedCrossRef
44.
Spitzer RL, Kroenke K, Williams JBW, Lowe B. A brief measure for assessing generalized anxiety disorder. Arch Intern Med. 2006;166(10):1092–7.PubMedCrossRef
45.
Buysse DJ, Reynolds III CF, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Research. 1989;28(2):193–213.
46.
Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): development and initial psychometric evaluation. J Trauma Stress. 2015;28(6):489–98.PubMedCrossRef
47.
48.
Carey KB, Carey MP, Chandra PS. Psychometric evaluation of the Alcohol Use Disorders Identification Test and Short Drug Abuse Screening Test with psychiatric patients in India. J Clin Psychiatry. 2003;64(7):767–74.PubMedPubMedCentralCrossRef
49.
Humeniuk R, Ali R; WHO ASSIST Phase II Study Group. Validation of the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) and Pilot Brief Intervention. Geneva: World Health Organization; 2006.
50.
Humeniuk R, Ali R, Babor TF, Farrell M, Formigoni ML, Jittiwutikarn J, et al. Validation of the alcohol, smoking and substance involvement screening test (ASSIST). Addiction. 2008;103(6):1039–47.PubMedCrossRef
51.
Krupp LB, Larocca NG, Muir Nash J, Steinberg AD. The fatigue severity scale: application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989;46(10):1121–3.PubMedCrossRef
52.
Minnock P, Kirwan J, Bresnihan B. Fatigue is a reliable, sensitive and unique outcome measure in rheumatoid arthritis. Rheumatology. 2009;48(12):1533–6.PubMedCrossRef
53.
Jensen MP, Turner JA, Romano JM, Fisher LD. Comparative reliability and validity of chronic pain intensity measures. Pain. 1999;83(2):157–62.PubMedCrossRef
54.
55.
Bestall JC, Paul EA, Garrod R, Garnham R, Jones PW, Wedzicha JA. Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease. Thorax. 1999;54(7):581–6.PubMedPubMedCentralCrossRef
56.
Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, et al. The Warwick-Dinburgh mental well-being scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007;5(1):63.
57.
Trousselard M, Steiler D, Dutheil F, Claverie D, Canini F, Fenouillet F, et al. Validation of the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) in French psychiatric and general populations. Psychiatry Res. 2016;245:282–90.PubMedCrossRef
58.
Maheswaran H, Weich S, Powell J, Stewart-Brown S. Evaluating the responsiveness of the Warwick Edinburgh Mental Well-Being Scale (WEMWBS): group and individual level analysis. Health Qual Life Outcomes. 2012;10(156):1–8.
59.
Sullivan MJL, Adams H, Horan S, Maher D, Boland D, Gross R. The role of perceived injustice in the experience of chronic pain and disability: scale development and validation. J Occup Rehabil. 2008;18(3):249–61.
60.
Felitti VJ, Anda RF, Nordenberg D, Williamson DF, Spitz AM, Edwards V, et al. Relationship of childhood abuse and household dysfunction to many of the leading causes of death in adults: the adverse childhood experiences (ACE) study. Am J Prev Med. 1998;14(4):245–58.
61.
Xie F, Pullenayegum E, Gaebel K, Bansback N, Bryan S, Ohinmaa A, et al. A time trade-off-derived value set of the EQ-5D-5L for Canada. Med Care. 2016;54(1):98–105.PubMedCrossRef
62.
Manca A, Hawkins N, Sculpher MJ. Estimating mean QALYs in trial-based cost-effectiveness analysis: the importance of controlling for baseline utility. Health Econ. 2005;14(5):487–96.PubMedCrossRef
63.
Bai F, Tomasoni D, Falcinella C, Barbanotti D, Castoldi R, Mulè G, Augello M, Mondatore D, Allegrini M, Cona A, Tesoro D. Female gender is associated with long COVID syndrome: a prospective cohort study. Clin Microbiol Infect. 2022;28(4):611.e9–16.
64.
Izcovich A, Ragusa MA, Tortosa F, Marzio MAL, Agnoletti C, Bengolea A, et al. Prognostic factors for severity and mortality in patients infected with COVID-19: a systematic review. PLoS One. 2020;15(11):e0241955.PubMedPubMedCentralCrossRef
65.
Rovere-Querini P, De Lorenzo R, Conte C, Brioni E, Lanzani C, Yacoub MR, et al. Post-COVID-19 follow-up clinic: depicting chronicity of a new disease. Acta Biomed. 2020;91(9-S):22–8.PubMedPubMedCentral
66.
67.
68.
69.
Metadata
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
Authors
Simon Hatcher
Joel Werier
Nicole E. Edgar
James Booth
D. William J. Cameron
Vicente Corrales-Medina
Daniel Corsi
Juthaporn Cowan
Pierre Giguère
Mark Kaluzienski
Shawn Marshall
Tiago Mestre
Bryce Mulligan
Heather Orpana
Amanda Pontefract
Darlene Stafford
Kednapa Thavorn
Guy Trudel
Publication date
01-12-2022
Publisher
BioMed Central
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06578-1

Other articles of this Issue 1/2022

Trials 1/2022 Go to the issue

Study protocol

Randomized double-blind controlled trial to assess the efficacy of intravenous acetaminophen associated with strong opioids in the treatment of acute pain in adult cancer patients: study protocol

Study protocol

A randomized, double-blind, placebo-controlled, hybrid parallel-arm study of low-dose naltrexone as an adjunctive anti-inflammatory treatment for major depressive disorder

Update

Effect of dexamethasone in patients with ARDS and COVID-19 (REMED trial)—study protocol for a prospective, multi-centre, open-label, parallel-group, randomized controlled trial

Methodology

Success and failure factors of patient recruitment for industry-sponsored clinical trials and the role of the electronic health records—a qualitative interview study in the Nordic countries

Research

Advancing cluster randomised trials in children’s therapy: a survey of the acceptability of trial behaviours to therapists and parents

Study protocol

Efficacy of platelet-rich plasma impregnation for unidirectional porous β-tricalcium phosphate in lateral lumbar interbody fusion: study protocol for a prospective controlled trial