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

This study is currently recruiting participants. (see Contacts and Locations)
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

November 13, 2013
December 5, 2013
October 2013
October 2018   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02007265 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Post-stroke Triage "DOC": Simple Screening for Depression, Obstructive Sleep Apnea and Cognitive Impairment
Post-stroke Triage "DOC": Simple Screening for Depression, Obstructive Sleep Apnea and Cognitive Impairment

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

All consecutive patients attending outpatient TIA and Stroke Prevention Clinics.

  • Transient Ischemic Attack
  • Stroke
  • Depression
  • Obstructive Sleep Apnea
  • Cognitive Impairment
Not Provided
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2800
October 2018
October 2018   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact: Richard H Swartz, MD 416-480-4866 rick.swartz@sunnybrook.ca
Canada
 
NCT02007265
306-2011, No. 000392
No
Dr. Rick Swartz, Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
Heart and Stroke Foundation of Ontario
Principal Investigator: Richard H Swartz, MD, PhD, Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP