DOC Utility: Screening of Depression, Obstructive Sleep Apnea and Cognitive Impairment

• Conditions: Depression; Cognitive Impairment; Transient Ischemic Attack; Obstructive Sleep Apnea; Stroke

• Registration Number: NCT02363114
• Lead Sponsor: Dr. Richard H. Swartz

Brief Summary

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.

Detailed Description

The DOC screen will be routinely applied to all patients presenting to three high volume Regional Stroke Prevention Clinics (combined first visits \>2,800 patients per year). Data will be abstracted from the patient chart using methodologies developed and validated in the Registry of the Ontario Stroke Network. The investigators have REB approval to collect this data and to link with administrative datasets through the Institute for Clinical and Evaluative Sciences (ICES). The investigators will use regression models to determine whether DOC screen scores add to baseline clinical and demographic data to predict the main negative outcomes. The investigators hope to identify which patients presenting to TIA/stroke prevention clinics are at highest risk of adverse long-term events so focused interventions can be developed to improve survival, outcomes and function of stroke prevention clinic patients.

Study Timeline

• Study Start: 2014-04-01
• Study First Submitted: 2015-02-09
• Study First Submitted QC: 2015-02-12
• Study First Posted: 2015-02-13
• Primary Completion: 2017-09-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-21
• Last Update Posted: 2021-09-22
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants with any Adverse Event	1 Year from Initial Screen Date	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with recurrent stroke	1 Year from Initial Screen Date	The number of participants with the occurrence of recurrent stroke within one year of screening
Incidence of DOC co-morbidities	1 Year from Initial Screen Date	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
Number of Participants with myocardial infarction	1 Year from Initial Screen Date	The number of participants with the occurrence of myocardial infarction within one year of screening
Number of Participants who died	1 Year from Initial Screen Date	The number of participants who died within one year of screening
Number of Participants who have been admitted to a long-term care or complex continuing care facility	1 Year from Initial Screen Date	The number of participants who have been admitted to a long-term care or complex continuing care facility within one year of screening

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada