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Electronic Case Management for Long COVID (ECORT Trial)
N/A
Waitlist Available
Research Sponsored by University of Ottawa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be 18 years of age or older
Have at least one ongoing symptom consistent with Long COVID as measured by the WHO Post COVID Case Report Form (CRF)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 4, week8 and week 12
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to determine if adding electronic case management will improve quality of life for patients with Long COVID, as well as if it is cost effective.
Who is the study for?
This trial is for adults over 18 who had COVID-19 confirmed by a test or meet certain criteria, still have symptoms after 12 weeks, and can use email and a smartphone app. They must understand English or French and be able to consent. People with other long-term conditions that explain their symptoms or those in another treatment study for Long COVID are excluded.
What is being tested?
The study tests if adding electronic case management via NexJ Connected Wellness to usual care improves life quality for Long COVID patients at The Ottawa Hospital. Participants will either receive standard care or enhanced care with the digital platform, randomly assigned, and complete regular questionnaires about health outcomes.
What are the potential side effects?
Since this trial involves usual care plus the addition of an electronic case management system rather than medication, there are no direct medical side effects expected from using NexJ Connected Wellness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am experiencing symptoms that match Long COVID.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in WHODAS 2.0 score
Secondary study objectives
ASSIST
AUDIT
Digit Span subset
+14 moreSide effects data
From 2016 Phase 3 trial • 300 Patients • NCT0200856551%
Constipation
9%
Urinary tract infection
6%
Diarrhoea
6%
Headache
5%
Fall
5%
Abdominal distension
5%
Abdominal pain
5%
Upper respiratory tract infection
3%
Nausea
2%
Haemorrhoids
1%
Hip fracture
1%
Breast cancer
1%
Syncope
1%
Medical device removal
1%
Back pain
1%
Animal bite
1%
Suture related complication
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo - Education Only
Loperamide - Exercise Plus Biofeedback
Loperamide - Education Only
Placebo - Exercise Plus Biofeedback
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Electronic Case Management plus Usual CareExperimental Treatment2 Interventions
Participants randomized to the experimental arm will receive assessment, investigation and management as the Active Comparator Arm plus access to an electronic case management platform - NexJ Connected Wellness (https://nexjhealth.com/) which complements the rehabilitation plan. This would include for example setting targets for activity that would be monitored with NexJ; educational materials; and support with medication adherence by reminders. The NexJ platform will include the following sections: Trusted Educational Content (Health Library); Symptom Tracking, Goal Setting, Community Forums and Reporting.
Group II: Usual CareActive Control1 Intervention
Assessment. Participants randomized to the control arm will be offered assessment by a clinician, guided by the WHO Post COVID-19 case report form. This is a clinical tool developed by WHO to guide and document the sequelae of COVID-19 and to ensure that clinical and rehabilitation needs are identified.
Investigation. Clinician judgement will be used to decide on further testing needed for clinical care.
Management. Control participants will receive a rehabilitation plan developed with their health professional that will be implemented in the eight weeks after their initial consultation (baseline visit). The implementation will involve face to face or virtual care from a registered health professional provided by the clinic or research staff. This may be a combination of, but not limited to, occupational therapy, physical therapy and/or social work/counselling. The frequency of treatment visits will depend on the individual treatment plan after assessment.
Find a Location
Who is running the clinical trial?
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,393 Previous Clinical Trials
26,527,558 Total Patients Enrolled
Ottawa Hospital Research InstituteOTHER
577 Previous Clinical Trials
3,139,842 Total Patients Enrolled
University of OttawaLead Sponsor
221 Previous Clinical Trials
269,543 Total Patients Enrolled