DOC Utility: Screening of Depression, Obstructive Sleep Apnea and Cognitive Impairment

NCT02363114 | Unknown

• 2 other identifiers: 141-20141012404
• Study Type: observational
• Target: 6,500
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to determine whether baseline DOC screening can add to clinical and demographic data to predict the occurrence of a composite negative outcome (any of: recurrent stroke, myocardial infarction, death, or admission to a long-term care (LTC) / complex continuing care (CCC) facility) within one year of screening, in stroke prevention clinic patients.

Conditions

Stroke; Transient Ischemic Attack; Depression; Obstructive Sleep Apnea; Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Number of Participants with any Adverse Event

  A composite negative outcome will be created, defined as the occurrence of any recurrent stroke, myocardial infarction, death, or admission to a long-term care (LTC) / complex continuing care (CCC) facility within one year of screening.

  1 Year from Initial Screen Date

Secondary Outcomes (5)

• Number of Participants with recurrent stroke

  1 Year from Initial Screen Date

• Incidence of DOC co-morbidities

  1 Year from Initial Screen Date

• Number of Participants with myocardial infarction

  1 Year from Initial Screen Date

• Number of Participants who died

  1 Year from Initial Screen Date

• Number of Participants who have been admitted to a long-term care or complex continuing care facility

  1 Year from Initial Screen Date

Study Arms (1)

Stroke Prevention Clinic Patients

All consecutive patients presenting to six high volume Regional Stroke Prevention Clinics.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients attending outpatient Stroke Prevention and TIA Clinics.

You may qualify if:

• Consecutive patients referred to regional stroke prevention clinics.
• This includes those discharged from hospital with a diagnosis of stroke or TIA, as well as emergency department referrals.
• The DOC CRF will also be completed for patients who are unable to complete the screen due to severe aphasia, severe motor dysfunction and language barriers (those who are not fluent in English without translation available).

You may not qualify if:

• Patients whose reason for referral to the clinic is neither Stroke nor TIA, as well as those who have been admitted to LTC/CCC facilities at the time of clinic visit.

Sponsors & Collaborators

• Dr. Richard H. Swartz: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Stroke; Ischemic Attack, Transient; Depression; Sleep Apnea, Obstructive; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Behavioral Symptoms; Behavior; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Cognition Disorders; Neurocognitive Disorders; Mental 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
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: February 9, 2015
• First Posted: February 13, 2015
• Study Start: April 1, 2014
• Primary Completion: September 30, 2017
• Study Completion: December 1, 2022
• Last Updated: September 22, 2021

Record last verified: 2021-09

Locations

CA (1)