Post-stroke Triage "DOC": Simple Screening for Depression... | NCT02007265

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

NCT02007265

Sponsor

Sunnybrook Health Sciences Centre

Status

Completed

Last Update Posted

Nov 25, 2015Estimated

Enrollment

1,504Actual

Phase

Not provided

Conditions

Transient Ischemic Attack
Stroke
Depression
Obstructive Sleep Apnea
Cognitive Impairment

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
No. 000392	Other Grant/Funding Number	Heart and Stroke Foundation of Ontario Grant

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Apr 2014Actual

Completion Date

Apr 2014Actual

First Submitted Date

Nov 13, 2013

First Submission Date that Met QC Criteria

Dec 5, 2013

First Posted Date

Dec 10, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 23, 2015

Last Update Posted Date

Nov 25, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Richard H. Swartz, Dr. Richard Swartz, Sunnybrook Health Sciences CentrePrincipal Investigator

Lead Sponsor

Sunnybrook Health Sciences CentreOTHER

Collaborators

Name	Class
Heart and Stroke Foundation of Ontario	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,504Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants with who completed the DOC Screen in 5 minutes or less	This outcome is defined as the number of DOC patients that took 5 minutes or less to complete the DOC Screening Form	Day 1

Secondary Outcomes

Measure	Description	Time Frame
DOC Screen Diagnostic Characteristics compared to Gold Standard Research Assessments	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.	Average 7 weeks

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All consecutive patients attending outpatient TIA and Stroke Prevention Clinics.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Richard H Swartz, MD, PhD,	Sunnybrook Health Sciences Centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sunnybrook Health Sciences Centre		Toronto	Ontario	M4N 3M5	Canada

Condition Browse Module

MeSH Terms

ID	Term
D002546	Ischemic Attack, Transient
D020521	Stroke
D003863	Depression
D020181	Sleep Apnea, Obstructive
D060825	Cognitive Dysfunction

Ancestor Terms

ID	Term
D002545	Brain Ischemia
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided