Post-stroke Triage "DOC": Simple Screening for Depression, Obstructive Sleep Apnea and Cognitive Impairment

This study has been completed.
Heart and Stroke Foundation of Ontario
Information provided by (Responsible Party):
Dr. Richard H. Swartz, Sunnybrook Health Sciences Centre Identifier:
First received: November 13, 2013
Last updated: November 23, 2015
Last verified: November 2015
The purpose of this study is to determine whether simple, evidence-based clinical screening be quickly and feasibly implemented (>85% of patients in an average of <6 minutes) in large-volume urgent transient ischemic attack (TIA)/stroke clinics to identify individuals at high risk for the three most common and devastating post-stroke co-morbidities (depression, obstructive sleep apnea and cognitive disorders).

Transient Ischemic Attack
Obstructive Sleep Apnea
Cognitive Impairment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-stroke Triage "DOC": Simple Screening for Depression, Obstructive Sleep Apnea and Cognitive Impairment

Resource links provided by NLM:

Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Number of Participants with who completed the DOC Screen in 5 minutes or less [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    This outcome is defined as the number of DOC patients that took 5 minutes or less to complete the DOC Screening Form

Secondary Outcome Measures:
  • DOC Screen Diagnostic Characteristics compared to Gold Standard Research Assessments [ Time Frame: Average 7 weeks ] [ Designated as safety issue: No ]
    To determine the diagnostic characteristics of the mini-screens compared to gold standard research assessments and to determine whether when applied as one integrated test in a stroke clinic population they perform comparably to previously published studies.

Enrollment: 1504
Study Start Date: April 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
TIA and SPC outpatients
All consecutive patients attending outpatient TIA and Stroke Prevention Clinics at three regional stroke centres will be eligible to be screened.

Detailed Description:
We have created a simple screening tool (the "DOC" Screen) that will be routinely applied to all patients at a high-volume Regional Stroke Prevention Clinic. Consenting patients will also undergo "gold standard" research assessments in order to determine the diagnostic characteristics of the screen compared to gold standard research assessments.The proportion of eligible patients who complete DOC screening and the time for completion (mean, range, standard deviations) will be calculated from aggregated data for all new consults in the stroke prevention clinic. For patients who consented to undergo gold standard testing, sensitivity, specificity, positive predictive value, negative predictive value and likelihood ratios of the DOC screen will be calculated. Screening cut-points will be optimized using Receiver Operating Characteristic (ROC) and area under the curve analysis, and logistic regression will be applied to this ROC Curve analysis to control for variables such as age, sex, BMI and education. We hope to develop a pragmatic approach to screening the large, high-risk stroke prevention clinic population, allowing broad screening for these important health conditions. This could change routine standard of care across stroke prevention clinics and facilitate early identification and appropriate assessment of patients.

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All consecutive patients attending outpatient TIA and Stroke Prevention Clinics.

Inclusion Criteria:

  • Attending outpatient TIA and Stroke Prevention Clinics at any of the three regional stroke centres.

Exclusion Criteria:

  • Those who are unable to complete the screen complete the screen due to severe aphasia, severe motor dysfunction and those who are not fluent in English without translation available.
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Please refer to this study by its identifier: NCT02007265

Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Heart and Stroke Foundation of Ontario
Principal Investigator: Richard H Swartz, MD, PhD, Sunnybrook Health Sciences Centre
  More Information

No publications provided

Responsible Party: Dr. Richard H. Swartz, Dr. Richard Swartz, Sunnybrook Health Sciences Centre Identifier: NCT02007265     History of Changes
Other Study ID Numbers: 306-2011, No. 000392
Study First Received: November 13, 2013
Last Updated: November 23, 2015
Health Authority: Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee
Canada: Health Canada
Canada: Ministry of Health & Long Term Care, Ontario
Canada: Public Health Agency of Canada

Additional relevant MeSH terms:
Cognition Disorders
Depressive Disorder
Ischemic Attack, Transient
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Behavioral Symptoms
Brain Diseases
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Mood Disorders
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic
Vascular Diseases processed this record on November 27, 2015