StrokeNCT02363114
DOC Utility: Screening of Depression, Obstructive Sleep Apnea and Cognitive Impairment
An observational study of Stroke and Transient Ischemic Attack, run by Dr. Richard H. Swartz at 1 site in Canada.
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)… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Transient Ischemic Attack, Depression
- How many people
- 6,500 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2014to 1 Dec 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All consecutive patients attending outpatient Stroke Prevention and TIA Clinics.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DOC Utility: Simple Screening of Depression, Obstructive Sleep Apnea and Cognitive Impairment to Identify Stroke Clinic Patients at Risk of Adverse Outcomes
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.
Read the detailed 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.
- Conditions
- Stroke, Transient Ischemic Attack, Depression, Obstructive Sleep Apnea, Cognitive Impairment
- Medical subject headings
- Stroke, Ischemic Attack, Transient, Depression, Sleep Apnea, Obstructive, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stroke Prevention Clinic Patients | All consecutive patients presenting to six high volume Regional Stroke Prevention Clinics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 Year from Initial Screen Date
Secondary outcomes (5)
Number of Participants with recurrent stroke
The number of participants with the occurrence of recurrent stroke within one year of screening
Measured: 1 Year from Initial Screen Date
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
Measured: 1 Year from Initial Screen Date
Number of Participants with myocardial infarction
The number of participants with the occurrence of myocardial infarction within one year of screening
Measured: 1 Year from Initial Screen Date
Number of Participants who died
The number of participants who died within one year of screening
Measured: 1 Year from Initial Screen Date
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
Measured: 1 Year from Initial Screen Date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2015 (estimated)
- Study start1 Apr 2014
- Primary completion30 Sep 2017
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,500 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Dr. Richard H. Swartz
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor-investigator, Dr. Richard H. Swartz, Sunnybrook Health Sciences Centre
- Investigators
- Richard H Swartz, MD, PHD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363114
- Sponsor's protocol ID
- 141-2014
- Other IDs
- 1012404
- Status last verified
- Sep 2021
- First submitted
- 9 Feb 2015
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DOC Utility: Simple Screening of Depression, Obstructive Sleep Apnea and Cognitive Impairment to Identify Stroke Clinic Patients at Risk of Adverse Outcomes
- ClinicalTrials.gov ID
- NCT02363114
- Acronym / sponsor ID
- 141-2014
- Conditions
- Stroke, Transient Ischemic Attack, Depression, Obstructive Sleep Apnea, Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,500 participants (actual)
- Lead sponsor
- Dr. Richard H. SwartzUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 13 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke Prevention Clinic Patients | – | –All consecutive patients presenting to six high volume Regional Stroke Prevention Clinics. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All consecutive patients attending outpatient Stroke Prevention and TIA Clinics.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants with any Adverse Event
Time frame: 1 Year from Initial Screen Date
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.
5 secondary outcomes
Number of Participants with recurrent stroke
Time frame: 1 Year from Initial Screen Date
Incidence of DOC co-morbidities
Time frame: 1 Year from Initial Screen Date
Number of Participants with myocardial infarction
Time frame: 1 Year from Initial Screen Date
Number of Participants who died
Time frame: 1 Year from Initial Screen Date
Number of Participants who have been admitted to a long-term care or complex continuing care facility
Time frame: 1 Year from Initial Screen Date
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard H Swartz, MD, PHD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Transient Ischemic Attack, run by Dr. Richard H. Swartz at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with any Adverse Event (time frame: 1 Year from Initial Screen Date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2021.