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

This study has been completed.
Sponsor:
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by (Responsible Party):
Dr. Richard H. Swartz, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT02007265
First received: November 13, 2013
Last updated: November 23, 2015
Last verified: November 2015

November 13, 2013
November 23, 2015
April 2012
April 2014   (final data collection date for primary outcome measure)
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
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.
Complete list of historical versions of study NCT02007265 on ClinicalTrials.gov Archive Site
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.
  • 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.
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 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).
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.
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.
 
Completed
1504
April 2014
April 2014   (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 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.
Both
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT02007265
306-2011, No. 000392
No
Not Provided
Not Provided
Dr. Richard H. 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
November 2015

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