Long COVID Clinical Trial
— STAR-C3Official title:
Symptom-Targeted Rehabilitation for Cognitive Complaints in Long COVID (STAR-C3)
NCT number | NCT05676047 |
Other study ID # | 15621 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2023 |
Est. completion date | December 1, 2024 |
The investigators are comparing two different methods for helping adults with Long Coronavirus (COVID) also known as Post-Coronavirus Syndrome or Post-Coronavirus Condition manage everyday cognitive challenges. Cognitive rehabilitation is a type of therapy that helps people who have challenges with everyday thinking because of a brain injury. One of the investigators on this project along with colleagues in the United States (US) have developed a streamlined version of cognitive rehabilitation therapy for mild traumatic brain injury (mTBI) that can be completed in person or virtually and takes place over a 3-week period. The therapy was originally designed for adults with mTBI. The investigators want to know if it can also be used to treat people with cognitive complaints from Long COVID. The investigators will provide education materials only to one group and individual cognitive rehabilitation delivered by a trained Speech Language Pathologist (SLP) or Occupational Therapist (OT) to the other group. The investigators want to find out whether the individual therapy is as feasible and accessible than the usual educational material. What the investigators learn in this study may help treat day-to-day thinking challenges in Long COVID.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 1, 2024 |
Est. primary completion date | November 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - Is a community-dwelling adults - Is age 18 years or older - Self-identifies as a fluent English speaker - Have a history of COVID symptoms as listed on the Government of Canada COVID information website, a positive antigen or polymerase chain reaction (PCR) test, or both - Have cognitive symptoms that have persisted a minimum of 12 weeks after contracting COVID - Have cognitive symptoms attributable to COVID and not to other intervening diagnoses associated with cognitive dysfunction (e.g., psychosis, concussion), or medications with negative effects on cognitive function - Have no previous history of a diagnosis of a neurological disorder affecting thinking (e.g., dementia) - Are able to participate in 3 one-hour sessions per week for 4-6 weeks - Are not in active behavioural treatment for a substance-use or mental-health disorder, or in cognitive rehabilitation provided by a registered health professional (e.g., speech-language pathologist or occupational therapist) - Can access an electronic device with internet access and capability for Zoom videoconferencing Exclusion Criteria: - A score of less than 20 on the Montreal Cognitive Assessment (MoCA), which indicates a risk for dementia. - Cannot identify at least 3 problems on the Common Cognitive Complaints after Concussion Questionnaire (C4), as there would be insufficient areas for intervention. |
Country | Name | City | State |
---|---|---|---|
Canada | McMaster University | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
McMaster University | Canadian Institutes of Health Research (CIHR) |
Canada,
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* Note: There are 40 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recruitment Rate | The primary outcome is the rate of recruitment, average 5 per month. The primary outcome is the rate of recruitment and retention rate reported as the total number of participants recruited and retained. | 9 months | |
Secondary | Acceptability of the Intervention | The acceptability will be assessed by clinicians and participants. At least three quarters of participants and clinicians will provide a rating of 4 on the Acceptability of Intervention Measure (AIM). | Measures administered during intake (baseline), immediately after one of sessions 6-10 depending on targets achieved, and 1 month post-treatment. | |
Secondary | Acceptability of the Appropriateness | The acceptability will be assessed by clinicians and participants. At least three quarters of participants and clinicians will provide a rating of 4 on the Intervention Appropriateness Measure (IAM). | Measures administered during intake (baseline), immediately after one of sessions 6-10 depending on targets achieved, and 1 month post-treatment. | |
Secondary | Acceptability of the Feasibility | The acceptability will be assessed by clinicians and participants. At least three quarters of participants and clinicians will provide a rating of 4 on the Feasibility of Intervention Measure (FIM). | Measures administered during intake (baseline), immediately after one of sessions 6-10 depending on targets achieved, and 1 month post-treatment |
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