Clinical trial NCT05019963: Enhancing COVID Rehabilitation With Technology
Official title: Enhancing COVID Rehabilitation With Technology (ECORT): An Open-label, Single Site Randomized Controlled Trial Evaluating the Effectiveness of Electronic Case Management for Individuals With Persistent COVID-19 Symptoms.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Covid19
Keywords: Long COVID
Post-COVID
Lead sponsor: University of Ottawa
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Ottawa Hospital Research Institute
First posted: 2021-08-25
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In March 2020, the World Health Organization (WHO) declared the novel coronavirus (COVID-19) a global pandemic. Ontario has confirmed more than 547,000 cases of COVID-19 since testing began. For many of these patients, symptoms resolve within 4 weeks of onset. However, it is becoming apparent that a significant number of individuals are experiencing symptoms that persist long after the acute infection, known as Long COVID. These individuals have a wide constellation of presenting symptoms, often varying from initial presentation. For this study, we will be enrolling individuals receiving care at The Ottawa Hospital for Long COVID. This study aims to determine the following four things: 1) will adding electronic case management improve quality of life three months after coming to hospital with Long COVID; 2) is the electronic case management platform cost effective; 3) is there any factors that predict outcomes at 3 months; 4) to determine how a personalized rehabilitation program supported by a digital platform could be implemented for individuals with Long COVID. We will enroll individuals from The Ottawa Hospital who will then be randomly assigned to receive either usual care or usual care plus electronic case management, through a platform called NexJ Connected Wellness. Participants will also complete questionnaires every 4 weeks for 3 months. We will be looking at quality of life, mental and physical health, cognitive symptoms, fatigue and pain.


Eligibility criteria: Inclusion Criteria

Participants must:

1. Be 18 years of age or older
2. Have a confirmed diagnosis of COVID-19 with a PCR test at least 12 weeks prior OR a confirmed Rapid Antigen Test at least 12-weeks prior OR meet Ottawa Public Health guidance for a suspected COVID-19 case
3. Have at least one ongoing symptom consistent with Long COVID as measured by the WHO Post COVID Case Report Form (CRF)
4. Have a minimum WHODAS (36 item) sum score of 15
5. Be willing to use email for study activities
6. Be able and willing to use a smart phone application for the duration of the trial
7. Be able to read and understand English or French.
8. Be willing and able to provide informed consent.

Exclusion Criteria

Participants must not:

1. Have any significant functional impairment (for example. advanced dementia, heart or lung disease) as judged by the assessing clinician
2. Participate in another long-COVID trial where treatment is required in the protocol (pharmacological or behavioural). Observational studies will be allowed.
3. Have symptoms consistent with Long COVID that are better explained by an alternative diagnosis

Primary outcomes:
measure: Change in WHODAS 2.0 score
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: WHO Post-COVID CRF
timeFrame: Module 1 will be administered at baseline only. Modules 2 and 3 will be administered at baseline and 12 weeks.
measure: PHQ-9
timeFrame: Baseline, Week 4, Week8 and Week 12
measure: GAD-7
timeFrame: Baseline, Week 4, Week8 and Week 12
measure: PSQI
timeFrame: Baseline, Week 4, Week8 and Week 12
measure: PCL-5
timeFrame: Baseline, Week 4, Week8 and Week 12
measure: EQ-5D-5L
timeFrame: Baseline, Week 4, Week8 and Week 12
measure: Fatigue Severity Scale
timeFrame: Baseline, Week 4, Week8 and Week 12
measure: Fatigue Numeric Rating Scale
timeFrame: Baseline, Week 4, Week8 and Week 12
measure: Pain Numeric Rating Scale
timeFrame: Baseline, Week 4, Week8 and Week 12
measure: MRC Dyspnoea Scale
timeFrame: Baseline, Week 4, Week8 and Week 12
measure: WEMWBS
timeFrame: Baseline and Week 12
measure: Oral Trail Making Test A and B
timeFrame: Baseline and Week 12
measure: Hopkins Verbal Learning Test-Revised (HVLT-R)
timeFrame: Baseline and Week 12
measure: Digit Span subset
timeFrame: Baseline and Week 12
measure: Phonemic and Semantic Verbal Fluency (or Controlled Oral Word Association Test)
timeFrame: Baseline and Week 12
measure: AUDIT
timeFrame: Baseline
measure: ASSIST
timeFrame: Baseline
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
Study officials:
References:
citation: Hatcher S, Werier J, Edgar NE, Booth J, Cameron DWJ, Corrales-Medina V, Corsi D, Cowan J, Giguere P, Kaluzienski M, Marshall S, Mestre T, Mulligan B, Orpana H, Pontefract A, Stafford D, Thavorn K, Trudel G. 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. Trials. 2022 Sep 2;23(1):728. doi: 10.1186/s13063-022-06578-1.