Transient Ischemic AttackNCT02007265
Post-stroke Triage "DOC": Simple Screening for Depression, Obstructive Sleep Apnea and Cognitive Impairment
An observational study of Transient Ischemic Attack and Stroke, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Transient Ischemic Attack, Stroke, Depression
- How many people
- 1,504 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2012to Apr 2014
- 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 TIA and Stroke Prevention Clinics.
Who may be able to join
- Attending outpatient TIA and Stroke Prevention Clinics at any of the three regional stroke centres.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Transient Ischemic Attack, Stroke, Depression, Obstructive Sleep Apnea, Cognitive Impairment
- Medical subject headings
- Ischemic Attack, Transient, Stroke, 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 |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Secondary outcomes (1)
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.
Measured: Average 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startApr 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transient Ischemic AttackStudies 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
- 1,504 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario
- Responsible party
- Principal 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
- NCT02007265
- Sponsor's protocol ID
- 306-2011
- Other IDs
- No. 000392
- Status last verified
- Nov 2015
- First submitted
- 13 Nov 2013
- Last updated
- 25 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-stroke Triage "DOC": Simple Screening for Depression, Obstructive Sleep Apnea and Cognitive Impairment
- ClinicalTrials.gov ID
- NCT02007265
- Acronym / sponsor ID
- 306-2011
- Conditions
- Transient Ischemic Attack, Stroke, Depression, Obstructive Sleep Apnea, Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,504 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario
- Study start
- Apr 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 10 Dec 2013 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All consecutive patients attending outpatient TIA and Stroke Prevention Clinics.
Key inclusion criteria (1 listed)
- Attending outpatient TIA and Stroke Prevention Clinics at any of the three regional stroke centres.
Key exclusion criteria (1 listed)
- 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.
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 who completed the DOC Screen in 5 minutes or less
Time frame: Day 1
This outcome is defined as the number of DOC patients that took 5 minutes or less to complete the DOC Screening Form
1 secondary outcome
DOC Screen Diagnostic Characteristics compared to Gold Standard Research Assessments
Time frame: Average 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2015.
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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 Transient Ischemic Attack and Stroke, run by Sunnybrook Health Sciences Centre 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 1 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: finished, as of the sponsor's last update on 25 Nov 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 who completed the DOC Screen in 5 minutes or less (time frame: Day 1). 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 25 Nov 2015.