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Completed

NCT Number: NCT02007265

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. DOC Screen Diagnostic Characteristics compared to Gold Standard Research Assessments

    Time frame: Average 7 weeks

    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.

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • Heart and Stroke Foundation of Ontario

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 10, 2013
Registry last updated
Nov 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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