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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
106
NexJ Connected Wellness is an electronic case management platform with a patient-facing smart phone application and a clinician-facing web dashboard.
Participants will receive a treatment plan as decided on with their clinician(s).
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
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.
Time frame: Baseline and Week 12
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.
Time frame: Module 1 will be administered at baseline only. Modules 2 and 3 will be administered at baseline and 12 weeks.
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).
Time frame: Baseline, Week 4, Week8 and Week 12
GAD-7
A 7-item questionnaire that assesses the severity of anxiety symptoms experienced within the last two weeks.
Time frame: Baseline, Week 4, Week8 and Week 12
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.
Time frame: Baseline, Week 4, Week8 and Week 12
PCL-5
A 20-item self-report measure that assesses the presence and severity of PTSD symptoms, corresponding with DSM-5 criteria for PTSD
Time frame: Baseline, Week 4, Week8 and Week 12
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.
Time frame: Baseline, Week 4, Week8 and Week 12
Fatigue Severity Scale
The Fatigue Severity Scale is a 9-item self-report that measures the severity and functional impact of fatigue.
Time frame: Baseline, Week 4, Week8 and Week 12
Fatigue Numeric Rating Scale
A single item patient reported outcome, scored on a scale of 0-10.
Time frame: Baseline, Week 4, Week8 and Week 12
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".
Time frame: Baseline, Week 4, Week8 and Week 12
MRC Dyspnoea Scale
A 5-item self report scale that evaluates statements of perceived breathlessness.
Time frame: Baseline, Week 4, Week8 and Week 12
WEMWBS
The Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) (short version) is a 7-item scale which measures multiple aspects of mental wellbeing.
Time frame: Baseline and Week 12
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).
Time frame: Baseline and Week 12
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.
Time frame: Baseline and Week 12
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).
Time frame: Baseline and Week 12
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).
Time frame: Baseline and Week 12
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).
Time frame: Baseline
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
Time frame: Baseline
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