Enhancing COVID Rehabilitation With Technology

NCT05019963 | Active Not Recruiting DMC

• 1 other identifier: 20210533-01H
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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

Keywords

Long COVID; Post-COVID

Outcome Measures

Primary Outcomes (1)

• Change in WHODAS 2.0 score

  The WHODAS is the 36-item self report questionnaire measuring health and disability from the previous 30 days across six domains of functioning: cognition, mobility, self-care, getting along, life activities and participation. Responses are scored on a 5 point Likert scale: None (0), Mild (1), Moderate (2), Severe (3), and Extreme/Cannot Do (4). Change from baseline to week 12 will be measured as primary outcome.

  Baseline and Week 12

Secondary Outcomes (17)

• WHO Post-COVID CRF

  Module 1 will be administered at baseline only. Modules 2 and 3 will be administered at baseline and 12 weeks.

• PHQ-9

  Baseline, Week 4, Week8 and Week 12

• GAD-7

  Baseline, Week 4, Week8 and Week 12

• PSQI

  Baseline, Week 4, Week8 and Week 12

• PCL-5

  Baseline, Week 4, Week8 and Week 12

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

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.

Other: Usual Care

Electronic Case Management plus Usual Care

EXPERIMENTAL

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.

Behavioral: NexJ Connected Wellness; Other: Usual Care

Interventions

NexJ Connected Wellness BEHAVIORAL

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

Electronic Case Management plus Usual Care

Usual Care OTHER

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

Electronic Case Management plus Usual Care; Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must:
• Be 18 years of age or older
• 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
• Have at least one ongoing symptom consistent with Long COVID as measured by the WHO Post COVID Case Report Form (CRF)
• Have a minimum WHODAS (36 item) sum score of 15
• Be willing to use email for study activities
• Be able and willing to use a smart phone application for the duration of the trial
• Be able to read and understand English or French.
• Be willing and able to provide informed consent.

You may not qualify if:

• Participants must not:
• Have any significant functional impairment (for example. advanced dementia, heart or lung disease) as judged by the assessing clinician
• Participate in another long-COVID trial where treatment is required in the protocol (pharmacological or behavioural). Observational studies will be allowed.
• Have symptoms consistent with Long COVID that are better explained by an alternative diagnosis

Sponsors & Collaborators

• University of Ottawa: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Ottawa Hospital Research Institute: collaborator

Study Sites (1)

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 7W9, Canada

Location

Related Publications (1)

• 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.

  PMID: 36056372 DERIVED

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Acting Chair, Department of Psychiatry

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 25, 2021
• Study Start: May 2, 2022
• Primary Completion: August 1, 2024
• Study Completion: September 1, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The study protocol will become available as soon as possible after ethical approval and implementation. The informed consent form will be shared as supporting documentation with the protocol.

Locations

CA (1)