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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 below

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I am 18 years old or older.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

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 more

Side effects data

From 2016 Phase 3 trial • 300 Patients • NCT02008565

51%

Constipation

Urinary tract infection

Diarrhoea

Headache

Fall

Abdominal distension

Abdominal pain

Upper respiratory tract infection

Nausea

Haemorrhoids

Breast cancer

Hip fracture

Syncope

Medical device removal

Back pain

Animal bite

Suture related complication

100%

80%

60%

40%

20%

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.

0 / 2Eligibility criteria met