Enhancing COVID Rehabilitation With Technology

Covid19 Clinical Trial

— ECORT  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05019963
• Other study ID #: 20210533-01H
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2022
• Est. completion date: September 2024

Study information

• Verified date: February 2024
• Source: University of Ottawa
• Contact: Kayla Jo Wells, HBSc
• Phone: 6137378899
• Email: kwells[@]ohri.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 152
• Est. completion date: September 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Behavioral:
• 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.

Other:
• Usual Care
Participants will receive a treatment plan as decided on with their clinician(s).

Locations

Country	Name	City	State
Canada	Ottawa Hospital Research Institute	Ottawa	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University of Ottawa	Canadian Institutes of Health Research (CIHR), Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	WHO Post-COVID CRF	The WHO Post-COVID CRF will measure characteristics of COVID-19 infection and post-COVID symptoms including demographics, pregnancy, pre-COVID health status, and details about the acute COVID infection, vaccination status, occupational status, functioning, post-COVID symptoms, clinical tests and scales (including neurological, radiographic, blood tests, heart and lung function, mental health, function, and musculoskeletal tests) new diagnoses or complications related to COVID infection, and health service use, symptoms.	Module 1 will be administered at baseline only. Modules 2 and 3 will be administered at baseline and 12 weeks.
Secondary	PHQ-9	A 9-item questionnaire that assesses the severity of depression symptoms experienced within the last two weeks. Participants are asked to rate each symptom of depression on a Likert scale from 0 (not at all) to 3 (nearly every day).	Baseline, Week 4, Week8 and Week 12
Secondary	GAD-7	A 7-item questionnaire that assesses the severity of anxiety symptoms experienced within the last two weeks.	Baseline, Week 4, Week8 and Week 12
Secondary	PSQI	The Pittsburgh Sleep Quality Index is a self-report questionnaire that assesses sleep quality in the previous month and takes 5-10 minutes to complete. It has been translated into over 50 languages.	Baseline, Week 4, Week8 and Week 12
Secondary	PCL-5	A 20-item self-report measure that assesses the presence and severity of PTSD symptoms, corresponding with DSM-5 criteria for PTSD	Baseline, Week 4, Week8 and Week 12
Secondary	EQ-5D-5L	This is a 5-item questionnaire that assesses health-related quality of life, including mobility, self-care, ability to participate in one's usual activities, pain or discomfort, and anxiety or depression and a Visual Analogue Scale (VAS) which asks participants to evaluate their overall health on a scale from 0-100.	Baseline, Week 4, Week8 and Week 12
Secondary	Fatigue Severity Scale	The Fatigue Severity Scale is a 9-item self-report that measures the severity and functional impact of fatigue.	Baseline, Week 4, Week8 and Week 12
Secondary	Fatigue Numeric Rating Scale	A single item patient reported outcome, scored on a scale of 0-10.	Baseline, Week 4, Week8 and Week 12
Secondary	Pain Numeric Rating Scale	The Pain Numeric Rating Scale will be used to assess pain intensity using a 0-10 ranking scale, where 0 represents "no pain" and 10 "unbearable pain".	Baseline, Week 4, Week8 and Week 12
Secondary	MRC Dyspnoea Scale	A 5-item self report scale that evaluates statements of perceived breathlessness.	Baseline, Week 4, Week8 and Week 12
Secondary	WEMWBS	The Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) (short version) is a 7-item scale which measures multiple aspects of mental wellbeing.	Baseline and Week 12
Secondary	Oral Trail Making Test A and B	Used to evaluate executive function, visual attention and task switching in participants. During TMT A, participants will be asked to count down out louad as quickly as they can sequentially, starting at "1" until the end. During TMT B, participants will be asked to speak outloud, alternating between numbers and letters (e.g. 1-A-2-B etc).	Baseline and Week 12
Secondary	Hopkins Verbal Learning Test-Revised (HVLT-R)	The Hopkins Verbal Learning Test-Revised (HVLT-R) will be used to evaluate verbal learning and memory capabilities in participants33. The HVLT consists of a 12-item word list, composed of four words from each of three semantic categories.	Baseline and Week 12
Secondary	Digit Span subset	The Digit Span subset, a component of the Working Memory Index of the Weschler's Adult Intelligence Scale - 4th Edition (WAIS-IV), will be used to assess attention and working memory34. Participants will be read a series of numbers and then asked to recall the numbers to the examiner in order (forward span), in reverse order (backward span) and in sequence (sequence span).	Baseline and Week 12
Secondary	Phonemic and Semantic Verbal Fluency (or Controlled Oral Word Association Test)	The Phonemic and Semantic Verbal Fluency (or Controlled Oral Word Association Test) test will be used to assess verbal fluency. Participants will be given one minute to produce as many unique words as possible: 1) within a semantic category (category fluency for Animals); and 2) starting with a given letter (letter fluency for letters F, A and S).	Baseline and Week 12
Secondary	AUDIT	Alcohol use: The AUDIT questionnaire is designed to assess alcohol consumption, drinking behavior, adverse reactions, alcohol-related problems. Among those who were known to misuse alcohol, the AUDIT successfully detected an alcohol use disorder 99% of the time 53. The AUDIT-C is the first 3-items of the AUDIT and will be used as a screening questionnaire. Participants who score above 4 on the AUDIT-C will also be asked to complete the Full AUDIT (the additional seven questions).	Baseline
Secondary	ASSIST	Alcohol and Substance Use: The ASSIST is a clinical interview collecting information regarding use of tobacco, alcohol, cannabis, cocaine, amphetamine type stimulants, sedatives, hallucinogens, inhalants, opioids, and other drugs. Internal Consistency (Chronbach's alpha) was over 0.80 for the majority of domains and good concurrent validity	Baseline