DementiaDemPoRTNCT03155815
Assessing Dementia Risk in the Community: The Dementia Population Risk Tool
An observational study of Dementia, run by Ottawa Hospital Research Institute.
Trial summary
The purpose of this study is to develop and validate the Dementia Population Risk Tool (DemPoRT) algorithm to predict dementia incidence in the population setting. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia
- How many people
- 75,460 participants
- Where
- No sites listed yet
- Study dates
- Sep 2000to Dec 2019
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The derivation cohort will be eligible respondents to the combined 2001, 2003, 2005 and 2007 Canadian Community Health Surveys, conducted by Statistics Canada. The validation cohort will consist of respondents to the 2008/2009 survey.
Who may be able to join
- Respondents to the Canadian Community Health Surveys
Who cannot join
- Less than 55 years of age at survey administration
- Prior history of dementia
- Not eligible for Ontario's universal health insurance program
About this study
Official title: Dementia Population Risk Tool (DemPoRT): A Predictive Algorithm for Assessing Dementia Risk in the Community Setting
The purpose of this study is to develop and validate the Dementia Population Risk Tool (DemPoRT) algorithm to predict dementia incidence in the population setting.
Read the detailed description
The burden of disease from dementia is a growing global concern as incidence increases exponentially with age and average life expectancy has been increasing around the world. Planning for an aging population requires reliable projections of future dementia prevalence and resource requirements, however, existing population projections are simple and have poor predictive accuracy. The Dementia Population Risk Tool (DemPoRT) will predict incidence of dementia in the population setting using multivariable modeling techniques.
The derivation cohort will consist of elderly Ontario respondents of Canadian Community Health Survey (CCHS) (2001, 2003, 2005, 2007; approximately 19 000 males and 25 000 females). Pre-specified predictors include sociodemographic, general health, behavioral, functional and health condition variables. Incident dementia will be identified through individual linkage of survey respondents to population-level administrative health care databases. Using time of first dementia capture as the primary outcome and death as a competing risk, sex-specific proportional hazards regression models will be estimated. The 2008/2009 CCHS survey be used for validation (approximately 4 600 males and 6 300 females). Overall calibration and discrimination will be assessed as well as calibration within predefined subgroups of importance to clinicians and policy makers.
- Conditions
- Dementia
- Medical subject headings
- Dementia
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 |
|---|---|---|
| Derivation Cohort | Eligible respondents to the combined 2001, 2003, 2005 and 2007 Canadian Community Health Surveys, conducted by Statistics Canada. | |
| Validation Cohort | Eligible respondents to the 2008/2009 Canadian Community Health Survey. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dementia capture in administrative data
Identification of incident dementia in administrative data using a validated case ascertainment definition, supplemented by dementia codes captured on home care and long-term care assessments
Measured: Up to 13 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study startSep 2000
- Primary completionMar 2014
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 75,460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Institute for Clinical Evaluative Sciences
- Responsible party
- Sponsor
- Investigators
- Peter Tanuseputro, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03155815
- Sponsor's protocol ID
- CIHR FRN 142237
- Acronym
- DemPoRT
- Status last verified
- Feb 2020
- First submitted
- 11 May 2017
- Last updated
- 17 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fisher S, Hsu A, Mojaverian N, Taljaard M, Huyer G, Manuel DG, Tanuseputro P. Dementia Population Risk Tool (DemPoRT): study protocol for a predictive algorithm assessing dementia risk in the community. BMJ Open. 2017 Oct 24;7(10):e018018. doi: 10.1136/bmjopen-2017-018018.
PubMed 29070641
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dementia Population Risk Tool (DemPoRT): A Predictive Algorithm for Assessing Dementia Risk in the Community Setting
- ClinicalTrials.gov ID
- NCT03155815
- Acronym / sponsor ID
- DemPoRT / CIHR FRN 142237
- Conditions
- Dementia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75,460 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Institute for Clinical Evaluative Sciences
- Study start
- Sep 2000 (actual)
- Primary completion
- Mar 2014 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 16 May 2017 (actual)
- 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 develop and validate the Dementia Population Risk Tool (DemPoRT) algorithm to predict dementia incidence in the population setting.
Detailed description
The burden of disease from dementia is a growing global concern as incidence increases exponentially with age and average life expectancy has been increasing around the world. Planning for an aging population requires reliable projections of future dementia prevalence and resource requirements, however, existing population projections are simple and have poor predictive accuracy. The Dementia Population Risk Tool (DemPoRT) will predict incidence of dementia in the population setting using multivariable modeling techniques.
The derivation cohort will consist of elderly Ontario respondents of Canadian Community Health Survey (CCHS) (2001, 2003, 2005, 2007; approximately 19 000 males and 25 000 females). Pre-specified predictors include sociodemographic, general health, behavioral, functional and health condition variables. Incident dementia will be identified through individual linkage of survey respondents to population-level administrative health care databases. Using time of first dementia capture as the primary outcome and death as a competing risk, sex-specific proportional hazards regression models will be estimated. The 2008/2009 CCHS survey be used for validation (approximately 4 600 males and 6 300 females). Overall calibration and discrimination will be assessed as well as calibration within predefined subgroups of importance to clinicians and policy makers.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Derivation Cohort | – | –Eligible respondents to the combined 2001, 2003, 2005 and 2007 Canadian Community Health Surveys, conducted by Statistics Canada. |
| Validation Cohort | – | –Eligible respondents to the 2008/2009 Canadian Community Health Survey. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The derivation cohort will be eligible respondents to the combined 2001, 2003, 2005 and 2007 Canadian Community Health Surveys, conducted by Statistics Canada. The validation cohort will consist of respondents to the 2008/2009 survey.
Key inclusion criteria (1 listed)
- Respondents to the Canadian Community Health Surveys
Key exclusion criteria (3 listed)
- Less than 55 years of age at survey administration
- Prior history of dementia
- Not eligible for Ontario's universal health insurance program
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
Dementia capture in administrative data
Time frame: Up to 13 years
Identification of incident dementia in administrative data using a validated case ascertainment definition, supplemented by dementia codes captured on home care and long-term care assessments
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 17 Feb 2020.
- Background: PubMed 29070641Fisher S, Hsu A, Mojaverian N, Taljaard M, Huyer G, Manuel DG, Tanuseputro P. Dementia Population Risk Tool (DemPoRT): study protocol for a predictive algorithm assessing dementia risk in the community. BMJ Open. 2017 Oct 24;7(10):e018018. doi: 10.1136/bmjopen-2017-018018.
- Individual participant dataSharing planned: No
Related trials for Dementia
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
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.
Peter Tanuseputro principal investigator
Ottawa Hospital Research Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia, run by Ottawa Hospital Research Institute.
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 3 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 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Dementia capture in administrative data (time frame: Up to 13 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03155815, which also lists 1 linked publication.
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 17 Feb 2020.