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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Depression; Stroke; Cognitive Impairment; Transient Ischemic Attack; Obstructive Sleep Apnea

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 Type: Observational
• Enrollment (Actual): 6500

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients attending outpatient Stroke Prevention and TIA Clinics.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Stroke Prevention Clinic Patients; All consecutive patients presenting to six high volume Regional Stroke Prevention Clinics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Number of Participants who died	The number of participants who died within one year of screening	1 Year from Initial Screen Date
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

Collaborators and Investigators

• Sponsor: Dr. Richard H. Swartz
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Richard H Swartz, MD, PHD, Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): September 30, 2017
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: February 9, 2015
• First Submitted That Met QC Criteria: February 12, 2015
• First Posted (Estimate): February 13, 2015

Study Record Updates

• Last Update Posted (Actual): September 22, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Mood Disorders; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Neurocognitive Disorders; Signs and Symptoms, Respiratory; Brain Ischemia; Cognition Disorders; Depression; Depressive Disorder; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Ischemic Attack, Transient; Cognitive Dysfunction
• Other Study ID Numbers: 141-2014; 1012404 (Other Grant/Funding Number: Canadian Institutes of Health Research)