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

This study is currently recruiting participants.
Verified December 2013 by Sunnybrook Health Sciences Centre
Sponsor:
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by (Responsible Party):
Dr. Rick Swartz, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT02007265
First received: November 13, 2013
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to determine whether simple, evidence-based clinical screening for the three most common and important post-stroke comorbidities (depression, obstructive sleep apnea and cognitive disorders) 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 large-volume stroke prevention clinics.


Condition
Transient Ischemic Attack
Stroke
Depression
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 any Adverse Event [ Time Frame: 1 year from initial screen date ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 year from initial screen ] [ Designated as safety issue: No ]
    The number or participants with the occurrence of recurrent stroke within one year of screening.

  • Incidence of DOC co-morbidities [ Time Frame: 1 year from initial screen ] [ Designated as safety issue: No ]
    To describe the incidence of DOC co-morbidities and outcomes in clinically important sub-groups (e.g. stroke-in-the-young, women vs. men, stroke in the "oldest-old" patients, TIA vs. ischemic stroke)

  • The number of participants with myocardial infarction [ Time Frame: 1 year from inital screening ] [ Designated as safety issue: No ]
    The number or participants with the occurrence of myocardial infarction within one year of screening.

  • The number of participants who died. [ Time Frame: 1 year from initial visit ] [ Designated as safety issue: No ]
    The number or 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 [ Time Frame: 1 year from inital screen ] [ Designated as safety issue: No ]
    The number or participants who have been admitted to a long-term care or complex continuing care facility within one year of screening.


Estimated Enrollment: 2800
Study Start Date: October 2013
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
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:

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. We have research ethics board approval to collect this data and to link with administrative data-sets through the Institute for Clinical and Evaluative Sciences (ICES). We will use regression models to determine whether DOC screen scores add to baseline clinical and demographic data to predict the main negative outcomes. We 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

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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Those who are admitted to LTC / CCC facilities at time of clinic visit will be excluded from the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02007265

Contacts
Contact: Richard H Swartz, MD 416-480-4866 rick.swartz@sunnybrook.ca

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Richard H Swartz, MD, PhD    416-480-4866    rick.swartz@sunnybrook.ca   
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Heart and Stroke Foundation of Ontario
Investigators
Principal Investigator: Richard H Swartz, MD, PhD, Sunnybrook Health Sciences Centre
  More Information

No publications provided

Responsible Party: Dr. Rick Swartz, Dr. Richard Swartz, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT02007265     History of Changes
Other Study ID Numbers: 306-2011, No. 000392
Study First Received: November 13, 2013
Last Updated: December 5, 2013
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:
Apnea
Ischemic Attack, Transient
Depression
Depressive Disorder
Sleep Apnea Syndromes
Stroke
Cerebral Infarction
Cognition Disorders
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Brain Infarction
Delirium, Dementia, Amnestic, Cognitive Disorders

ClinicalTrials.gov processed this record on April 17, 2014