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Clinical Trials/NCT02007265
NCT02007265
Completed
Not Applicable

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

Sunnybrook Health Sciences Centre1 site in 1 country1,504 target enrollmentApril 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Transient Ischemic Attack
Sponsor
Sunnybrook Health Sciences Centre
Enrollment
1504
Locations
1
Primary Endpoint
Number of Participants with who completed the DOC Screen in 5 minutes or less
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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).

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.

Registry
clinicaltrials.gov
Start Date
April 2012
End Date
April 2014
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Richard H. Swartz

Dr. Richard Swartz

Sunnybrook Health Sciences Centre

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Number of Participants with who completed the DOC Screen in 5 minutes or less

Time Frame: Day 1

This outcome is defined as the number of DOC patients that took 5 minutes or less to complete the DOC Screening Form

Secondary Outcomes

  • DOC Screen Diagnostic Characteristics compared to Gold Standard Research Assessments(Average 7 weeks)

Study Sites (1)

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