Enhancing COVID Rehabilitation With Technology

NCT ID: NCT05019963

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-02
• Study Completion Date: 2024-09-30

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.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Usual Care

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.

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

Participants will receive a treatment plan as decided on with their clinician(s).

Electronic Case Management plus Usual Care

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 Type: EXPERIMENTAL

NexJ Connected Wellness

Intervention Type: BEHAVIORAL

NexJ Connected Wellness is an electronic case management platform with a patient-facing smart phone application and a clinician-facing web dashboard.

Usual Care

Intervention Type: OTHER

Participants will receive a treatment plan as decided on with their clinician(s).

Interventions

NexJ Connected Wellness

NexJ Connected Wellness is an electronic case management platform with a patient-facing smart phone application and a clinician-facing web dashboard.

Intervention Type: BEHAVIORAL

Usual Care

Participants will receive a treatment plan as decided on with their clinician(s).

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: collaborator

University of Ottawa

OTHER

Sponsor Role: lead

Responsible Party

Dr. Simon Hatcher

Acting Chair, Department of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 36056372 (View on PubMed)

Other Identifiers

20210533-01H

Identifier Type: -

Identifier Source: org_study_id