Covid19ECORTNCT05019963
Enhancing COVID Rehabilitation With Technology
A study testing NexJ Connected Wellness in people with Covid19, run by University of Ottawa at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- NexJ Connected Wellness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteCanada
- Study dates
- 2 May 2022to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
- Being tested
- NexJ Connected Wellness, Usual Care
- Keywords
- Long COVID, Post-COVID
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NexJ Connected WellnessBehavioural
NexJ Connected Wellness is an electronic case management platform with a patient-facing smart phone application and a clinician-facing web dashboard.
Usual CareOther
Participants will receive a treatment plan as decided on with their clinician(s).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: NexJ Connected Wellness; Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 12
Secondary outcomes (17)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Baseline, Week 4, Week8 and Week 12
Fatigue Numeric Rating Scale
A single item patient reported outcome, scored on a scale of 0-10.
Measured: 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".
Measured: Baseline, Week 4, Week8 and Week 12
MRC Dyspnoea Scale
A 5-item self report scale that evaluates statements of perceived breathlessness.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start2 May 2022
- Primary completionAug 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Ottawa Hospital Research Institute
- Responsible party
- Principal investigator, Dr. Simon Hatcher, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019963
- Sponsor's protocol ID
- 20210533-01H
- Acronym
- ECORT
- Status last verified
- Jul 2024
- First submitted
- 12 Aug 2021
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Principal Investigator will retain ownership of the dataset through the 10 year archiving period. The protocol will be published, at a minimum on an open-science platform (e.g. Open Science Framework or medRXiv). If the protocol is published in an academic journal, the Principal Investigator will ensure it is open access. The anonymized data set will be shared on an open access platform, such as Open Science Framework or Zenodo. The anonymized dataset may also be shared with the WHO to facilitate global post-COVID-19 research and treatment efforts.
Publications
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.
PubMed 36056372
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05019963
- Acronym / sponsor ID
- ECORT / 20210533-01H
- Conditions
- Covid19
- Keywords
- Long COVID, Post-COVID
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Ottawa Hospital Research Institute
- Study start
- 2 May 2022 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Other: Usual CareAssessment. 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. |
| Electronic Case Management plus Usual Care | Experimental | Behavioral: NexJ Connected Wellness, Other: Usual CareParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NexJ Connected WellnessNexJ Connected Wellness is an electronic case management platform with a patient-facing smart phone application and a clinician-facing web dashboard. | Behavioural | Electronic Case Management plus Usual Care |
| Usual CareParticipants will receive a treatment plan as decided on with their clinician(s). | Other | Electronic Case Management plus Usual Care, Usual Care |
Primary outcome
Change in WHODAS 2.0 score
Time frame: Baseline and Week 12
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.
17 secondary outcomes
WHO Post-COVID CRF
Time frame: Module 1 will be administered at baseline only. Modules 2 and 3 will be administered at baseline and 12 weeks.
PHQ-9
Time frame: Baseline, Week 4, Week8 and Week 12
GAD-7
Time frame: Baseline, Week 4, Week8 and Week 12
PSQI
Time frame: Baseline, Week 4, Week8 and Week 12
PCL-5
Time frame: Baseline, Week 4, Week8 and Week 12
EQ-5D-5L
Time frame: Baseline, Week 4, Week8 and Week 12
Fatigue Severity Scale
Time frame: Baseline, Week 4, Week8 and Week 12
Fatigue Numeric Rating Scale
Time frame: Baseline, Week 4, Week8 and Week 12
Pain Numeric Rating Scale
Time frame: Baseline, Week 4, Week8 and Week 12
MRC Dyspnoea Scale
Time frame: Baseline, Week 4, Week8 and Week 12
WEMWBS
Time frame: Baseline and Week 12
Oral Trail Making Test A and B
Time frame: Baseline and Week 12
Hopkins Verbal Learning Test-Revised (HVLT-R)
Time frame: Baseline and Week 12
Digit Span subset
Time frame: Baseline and Week 12
Phonemic and Semantic Verbal Fluency (or Controlled Oral Word Association Test)
Time frame: Baseline and Week 12
AUDIT
Time frame: Baseline
ASSIST
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Derived from this study: PubMed 36056372Hatcher 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.
- Individual participant dataSharing planned: Yes. The Principal Investigator will retain ownership of the dataset through the 10 year archiving period. The protocol will be published, at a minimum on an open-science platform (e.g. Open Science Framework or medRXiv). If the protocol is published in an academic journal, the Principal Investigator will ensure it is open access. The anonymized data set will be shared on an open access platform, such as Open Science Framework or Zenodo. The anonymized dataset may also be shared with the WHO to facilitate global post-COVID-19 research and treatment efforts.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NexJ Connected Wellness in people with Covid19, run by University of Ottawa at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in WHODAS 2.0 score (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05019963, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.