Stroke Clinical Trial
Official title:
DOC Utility: Simple Screening of Depression, Obstructive Sleep Apnea and Cognitive Impairment to Identify Stroke Clinic Patients at Risk of Adverse Outcomes
Verified date | September 2021 |
Source | Sunnybrook Health Sciences Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
The primary objective of this study is to determine whether baseline DOC screening can add to clinical and demographic data to predict the occurrence of a composite negative outcome (any of: recurrent stroke, myocardial infarction, death, or admission to a long-term care (LTC) / complex continuing care (CCC) facility) within one year of screening, in stroke prevention clinic patients.
Status | Active, not recruiting |
Enrollment | 6500 |
Est. completion date | December 1, 2022 |
Est. primary completion date | September 30, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Consecutive patients referred to regional stroke prevention clinics. - This includes those discharged from hospital with a diagnosis of stroke or TIA, as well as emergency department referrals. - The DOC CRF will also be completed for patients who are unable to complete the screen due to severe aphasia, severe motor dysfunction and language barriers (those who are not fluent in English without translation available). Exclusion Criteria: - Patients whose reason for referral to the clinic is neither Stroke nor TIA, as well as those who have been admitted to LTC/CCC facilities at the time of clinic visit. |
Country | Name | City | State |
---|---|---|---|
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Dr. Richard H. Swartz | Canadian Institutes of Health Research (CIHR) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants with any Adverse Event | A composite negative outcome will be created, defined as the occurrence of any recurrent stroke, myocardial infarction, death, or admission to a long-term care (LTC) / complex continuing care (CCC) facility within one year of screening. | 1 Year from Initial Screen Date | |
Secondary | Number of Participants with recurrent stroke | The number of participants with the occurrence of recurrent stroke within one year of screening | 1 Year from Initial Screen Date | |
Secondary | Incidence of DOC co-morbidities | To describe the incidence of DOC co-morbidities and outcomes in clinical important sub-groups (e.g. stroke-in-the-young, women vs. men, stroke in the "oldest-old" patients, TIA vs. ischemic stroke | 1 Year from Initial Screen Date | |
Secondary | Number of Participants with myocardial infarction | The number of participants with the occurrence of myocardial infarction within one year of screening | 1 Year from Initial Screen Date | |
Secondary | Number of Participants who died | The number of participants who died within one year of screening | 1 Year from Initial Screen Date | |
Secondary | Number of Participants who have been admitted to a long-term care or complex continuing care facility | The number of participants who have been admitted to a long-term care or complex continuing care facility within one year of screening | 1 Year from Initial Screen Date |
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