NCT02007265

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,504

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2013

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 10, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

November 25, 2015

Status Verified

November 1, 2015

Enrollment Period

2 years

First QC Date

November 13, 2013

Last Update Submit

November 23, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • DOC Screen Diagnostic Characteristics compared to Gold Standard Research Assessments

    Average 7 weeks

Study Arms (1)

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All consecutive patients attending outpatient TIA and Stroke Prevention Clinics.

You may qualify if:

  • Attending outpatient TIA and Stroke Prevention Clinics at any of the three regional stroke centres.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Ischemic Attack, TransientStrokeDepressionSleep Apnea, ObstructiveCognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavioral SymptomsBehaviorSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Richard H Swartz, MD, PhD,

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Richard Swartz

Study Record Dates

First Submitted

November 13, 2013

First Posted

December 10, 2013

Study Start

April 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

November 25, 2015

Record last verified: 2015-11

Locations