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

Sponsor

Dr. Richard H. Swartz (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02363114

Collaborator

Canadian Institutes of Health Research (CIHR) (Other)

6,500

Enrollment

Location

104

Anticipated Duration (Months)

62.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Transient Ischemic Attack Depression Obstructive Sleep Apnea Cognitive Impairment

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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

6500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

DOC Utility: Simple Screening of Depression, Obstructive Sleep Apnea and Cognitive Impairment to Identify Stroke Clinic Patients at Risk of Adverse Outcomes

Actual Study Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Sep 30, 2017

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Stroke Prevention Clinic Patients All consecutive patients presenting to six high volume Regional Stroke Prevention Clinics.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.