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

Stroke Clinical Trial

Official title:

DOC Utility: Simple Screening of Depression, Obstructive Sleep Apnea and Cognitive Impairment to Identify Stroke Clinic Patients at Risk of Adverse Outcomes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02363114
• Other study ID #: 141-2014
• Secondary ID: 1012404
• Status: Active, not recruiting
• Start date: April 1, 2014
• Est. completion date: December 1, 2022

Study information

• Verified date: September 2021
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

The DOC screen will be routinely applied to all patients presenting to three high volume Regional Stroke Prevention Clinics (combined first visits >2,800 patients per year). Data will be abstracted from the patient chart using methodologies developed and validated in the Registry of the Ontario Stroke Network. The investigators have REB approval to collect this data and to link with administrative datasets through the Institute for Clinical and Evaluative Sciences (ICES). The investigators will use regression models to determine whether DOC screen scores add to baseline clinical and demographic data to predict the main negative outcomes. The investigators hope to identify which patients presenting to TIA/stroke prevention clinics are at highest risk of adverse long-term events so focused interventions can be developed to improve survival, outcomes and function of stroke prevention clinic patients.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6500
• Est. completion date: December 1, 2022
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Apnea
• Cognitive Dysfunction
• Cognitive Impairment
• Depression
• Depressive Disorder
• Ischemic Attack, Transient
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Stroke
• Transient Ischemic Attack

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Richard H. Swartz	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants with recurrent stroke	The number of participants with the occurrence of recurrent stroke within one year of screening	1 Year from Initial Screen Date
Secondary	Incidence of DOC co-morbidities	To describe the incidence of DOC co-morbidities and outcomes in clinical important sub-groups (e.g. stroke-in-the-young, women vs. men, stroke in the "oldest-old" patients, TIA vs. ischemic stroke	1 Year from Initial Screen Date
Secondary	Number of Participants with myocardial infarction	The number of participants with the occurrence of myocardial infarction within one year of screening	1 Year from Initial Screen Date
Secondary	Number of Participants who died	The number of participants who died within one year of screening	1 Year from Initial Screen Date
Secondary	Number of Participants who have been admitted to a long-term care or complex continuing care facility	The number of participants who have been admitted to a long-term care or complex continuing care facility within one year of screening	1 Year from Initial Screen Date