Cognitive ImpairmentNCT01775683
Can we Predict Chronic Homelessness?
An observational study of Cognitive Impairment, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
Homeless men and women suffer more illness and sooner death compared to housed people. Among the homeless, there is a group that suffers more illness than others. This group is usually homeless for several months, makes up a smaller proportion of homeless people and uses more resources from emergency shelters than… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognitive Impairment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to Sep 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Homeless men and women, greater or equal to 18 years, English-speaking, in Ottawa, ON, Canada
Who may be able to join
- Men and women, greater than or equal to 18 years old, English speaking
- Group A: currently homeless and/or housed in an emergency shelter or housing facility for chronically homeless individuals ≥ 6 months
- Group B: not homeless ≥4 times in the last 3 years and currently living in stable housing ≥ 6 months and in the last 3 years, has been homeless ≤ 1 month
Who cannot join
- At the time of testing, individuals with the following characteristics will be excluded:
- Altered mental status (determined by Nurse Coordinator through participant response to questions regarding orientation to person, place and season - score of at least 2/3 is considered intact mental status).
- Present intoxication (determined by Nurse Coordinator through participant evaluation of odour, either alcohol or non-beverage alcohol).
- Currently violent or aggressive towards testers (determined by Nurse Coordinator)
Trial locations and contacts
1 site in 1 country.
Canada1 site
The Ottawa Hospital Rehabilitation Centre
Ottawa, Ontario, K1H 8M5
Claire Vayalumkal, BASc, MD, 613-737-7350 ext. 0, cvayalumkal@toh.on.ca
Claire Vayalumkal, BASc, MD
About this study
Official title: A Case-control Study to Determine Whether a Screening Measure of Executive Dysfunction, the Quick EXIT, is Predictive of Chronic Homelessness
Homeless men and women suffer more illness and sooner death compared to housed people. Among the homeless, there is a group that suffers more illness than others. This group is usually homeless for several months, makes up a smaller proportion of homeless people and uses more resources from emergency shelters than other homeless people. Some have asked if a difference in thinking skills explains how people who are homeless for a long time need more help in getting and keeping housing compared to other homeless persons.
In this study, thinking skills that help a person plan and make decisions will be screened among those who have been homeless for a long time and those who were homeless for a short time. If there is a difference, then screening may change how future homeless people get the help they need.
- Conditions
- Cognitive Impairment
- Keywords
- homelessness
- Medical subject headings
- 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 |
|---|---|---|
| Group A - chronically homeless | Men and women, greater than or equal to age 18 years, English-speaking, who are currently homeless and/or housed in an emergency shelter or housing facility for chronically homeless individuals ≥ 6 months. | |
| Group B - control/formerly homeless | Men and women, greater than or equal to 18 years, English-speaking who are not homeless ≥4 times in the last 3 years and currently living in stable housing ≥ 6 months and in the last 3 years, has been homeless ≤ 1 month |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Quick EXIT score
Measured: Within 2 weeks of recruitment
Secondary outcomes (1)
The Colour Trails test score
Measured: Within 2 weeks of recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire Vayalumkal, BASc, MD, Principal investigator, The Ottawa Hospital Rehabilitation Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01775683
- Sponsor's protocol ID
- 20120651-01H
- Status last verified
- Jan 2013
- First submitted
- 25 Sep 2012
- Last updated
- 25 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case-control Study to Determine Whether a Screening Measure of Executive Dysfunction, the Quick EXIT, is Predictive of Chronic Homelessness
- ClinicalTrials.gov ID
- NCT01775683
- Acronym / sponsor ID
- 20120651-01H
- Conditions
- Cognitive Impairment
- Keywords
- homelessness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 25 Jan 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.
Homeless men and women suffer more illness and sooner death compared to housed people. Among the homeless, there is a group that suffers more illness than others. This group is usually homeless for several months, makes up a smaller proportion of homeless people and uses more resources from emergency shelters than other homeless people. Some have asked if a difference in thinking skills explains how people who are homeless for a long time need more help in getting and keeping housing compared to other homeless persons.
In this study, thinking skills that help a person plan and make decisions will be screened among those who have been homeless for a long time and those who were homeless for a short time. If there is a difference, then screening may change how future homeless people get the help they need.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - chronically homeless | – | –Men and women, greater than or equal to age 18 years, English-speaking, who are currently homeless and/or housed in an emergency shelter or housing facility for chronically homeless individuals ≥ 6 months. |
| Group B - control/formerly homeless | – | –Men and women, greater than or equal to 18 years, English-speaking who are not homeless ≥4 times in the last 3 years and currently living in stable housing ≥ 6 months and in the last 3 years, has been homeless ≤ 1 month |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Homeless men and women, greater or equal to 18 years, English-speaking, in Ottawa, ON, Canada
Key inclusion criteria (3 listed)
- Men and women, greater than or equal to 18 years old, English speaking
- Group A: currently homeless and/or housed in an emergency shelter or housing facility for chronically homeless individuals ≥ 6 months
- Group B: not homeless ≥4 times in the last 3 years and currently living in stable housing ≥ 6 months and in the last 3 years, has been homeless ≤ 1 month
Key exclusion criteria (4 listed)
- Altered mental status (determined by Nurse Coordinator through participant response to questions regarding orientation to person, place and season - score of at least 2/3 is considered intact mental status).
- Present intoxication (determined by Nurse Coordinator through participant evaluation of odour, either alcohol or non-beverage alcohol).
- Currently violent or aggressive towards testers (determined by Nurse Coordinator)
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
The Quick EXIT score
Time frame: Within 2 weeks of recruitment
1 secondary outcome
The Colour Trails test score
Time frame: Within 2 weeks of recruitment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2013.
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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.
Claire Vayalumkal, BASc, MD principal investigator
The Ottawa Hospital Rehabilitation 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 Cognitive Impairment, run by Ottawa Hospital Research Institute 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 4 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 25 Jan 2013. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Quick EXIT score (time frame: Within 2 weeks of recruitment). 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 Jan 2013.