Clinical trial NCT02007265: Post-stroke Triage "DOC": Simple Screening for Depression, Obstructive Sleep Apnea and Cognitive Impairment
Official title: Post-stroke Triage "DOC": Simple Screening for Depression, Obstructive Sleep Apnea and Cognitive Impairment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transient Ischemic Attack
Stroke
Depression
Obstructive Sleep Apnea
Cognitive Impairment
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Ontario
First posted: 2013-12-10
Enrollment: 1504
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients attending outpatient TIA and Stroke Prevention Clinics.

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.

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.

Primary outcomes:
measure: Number of Participants with who completed the DOC Screen in 5 minutes or less
timeFrame: Day 1
Secondary outcomes:
measure: DOC Screen Diagnostic Characteristics compared to Gold Standard Research Assessments
timeFrame: Average 7 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Richard H Swartz, MD, PhD,
role: PRINCIPAL_INVESTIGATOR
References: