Clinical trial NCT02363114: DOC Utility: Screening of Depression, Obstructive Sleep Apnea and Cognitive Impairment
Official title: DOC Utility: Simple Screening of Depression, Obstructive Sleep Apnea and Cognitive Impairment to Identify Stroke Clinic Patients at Risk of Adverse Outcomes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Transient Ischemic Attack
Depression
Obstructive Sleep Apnea
Cognitive Impairment
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2015-02-13
Enrollment: 6500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients attending outpatient Stroke Prevention and TIA Clinics.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants with any Adverse Event
timeFrame: 1 Year from Initial Screen Date
Secondary outcomes:
measure: Number of Participants with recurrent stroke
timeFrame: 1 Year from Initial Screen Date
measure: Incidence of DOC co-morbidities
timeFrame: 1 Year from Initial Screen Date
measure: Number of Participants with myocardial infarction
timeFrame: 1 Year from Initial Screen Date
measure: Number of Participants who died
timeFrame: 1 Year from Initial Screen Date
measure: Number of Participants who have been admitted to a long-term care or complex continuing care facility
timeFrame: 1 Year from Initial Screen Date
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Richard H Swartz, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: