DementiaPC-DATANCT01548053
The Primary Care - Dementia Assessment and Treatment Algorithm
A study testing PC-DATA tool in people with Dementia and Alzheimer's Disease, run by Queen's University at 1 site in Canada.
Trial summary
Alzheimer's disease (AD) and related forms of dementia currently affect over 400,000 individuals in Canada and the numbers of community dwelling older adults with AD is rapidly growing. AD is associated with over $15 billion annually in care costs. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dementia, Alzheimer's Disease
- What is being tested?
- PC-DATA tool
- How many people
- 55 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2012to May 2016
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Primary Care Provider Inclusion Criteria:
- Primary care provider at participating sites
Primary Care Provider Exclusion Criteria:
- primary care provider at non-participating site
Patient Inclusion Criteria:
- Community-dwelling at time of initial presentation to primary care provider
- Age 60 years or older at time of initial assessment by primary care provider
- Presenting to primary care providers with cognitive or functional symptoms suggestive of Alzheimer's disease or other form of dementia
- Patient must have a caregiver or substitute decision maker
Patient Exclusion Criteria:
- Prevalent cases of dementia will be excluded from study population
- Individuals with dementia residing in long-term care or nursing homes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study Evaluating the Effects of a Primary Care - Dementia Assessment Treatment Algorithm on the Quality of Care Provided to Older Adults With Dementia in Primary Care Settings
Alzheimer's disease (AD) and related forms of dementia currently affect over 400,000 individuals in Canada and the numbers of community dwelling older adults with AD is rapidly growing. AD is associated with over $15 billion annually in care costs. Most individuals with AD are under the care of primary care providers (PCPs) including family physicians and primary care nurses. The evaluation and management of AD is challenging for PCPs and the quality of care provided to older adults with AD by PCP could be improved which would optimize outcomes for this vulnerable population. Provision of quality care to older adults with AD involves implementation of best practices as outlined in guidelines such as the Canadian Consensus Conference Guidelines on the Diagnosis and Treatment of Dementia. Utilizing a group of dementia researchers, PCPs, other knowledge users, and individuals affected by AD, this project will develop practical, clinically relevant resources for primary care physicians and nurses to aid in the evaluation of older adults with AD. A knowledge tool, the Primary Care - Dementia Assessment and Treatment Algorithm (DATA Tool) will be introduced into several primary care settings in Ontario using educational sessions with PCP with additional support from internet resource and a dementia care manager. The quality of dementia care provided to older adults newly diagnosed with AD will be assessed in the three years preceding the intervention compared to the year following the implementation. This project will also describe the process of knowledge exchange with PCPs, including potential barriers and facilitators of knowledge uptake and examine if the care provided during the intervention was patient-centred through interviews with patients and caregivers.
Research Objectives:
- Develop knowledge tools to facilitate assessment and treatment of AD by PCPs based on best evidence;
- Transfer these knowledge tools into a variety of primary care settings in Ontario; and,
- Evaluate the effects of this intervention on dementia quality of care, PCP application of knowledge, and the patient-centeredness of care.
- Conditions
- Dementia, Alzheimer's Disease
- Being tested
- PC-DATA tool
- Keywords
- Primary care, Dementia, Knowledge translation, Quality of care, Qualitative methods, Alzheimer's disease
- Medical subject headings
- Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PC-DATA toolOther
The implementation plan consists of educational sessions and a dementia care manager (DCM). The educational sessions consist of two components: a 1.5 hour group-based DATA tool implementation workshop with primary care providers (PCPs); and, a 1 hour follow-up session at study mid-point. The DCM will facilitate application of the DATA tool and provide direct support to PCPs during the study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of dementia care process quality indicators achieved.
The evaluation of quality indicators (QI) using chart audit data will be undertaken following initial assessment of dementia will be used to assess the quality of care provided to individuals with dementia. The change in number of QI satisfied following the intervention will be compared to a historical group of individuals assessed for dementia by each PCP in the 3 years preceding the intervention.
Measured: 1 year following implementation
Secondary outcomes (2)
Impact on learning and knowledge application
Qualitative interviews with family physicians and interprofessional primary care professional will be conducted using a grounded theory design will be conducted with primary care providers to identify key conceptual, contextual and process elements involved in the exchange and application of dementia-specific knowledge in the primary care context.
Measured: Approximately 9 months following intervention
Client-centred care
Interviews will be conducted with patients and careviers to seek to identify key elements of patient-centred care.
Measured: Approximately 9 months following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Dr. Dallas Seitz, Queen's University
- Investigators
- Dallas P Seitz, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01548053
- Sponsor's protocol ID
- PC-DATA1
- Acronym
- PC-DATA
- Status last verified
- Apr 2017
- First submitted
- 29 Feb 2012
- Last updated
- 14 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Evaluating the Effects of a Primary Care - Dementia Assessment Treatment Algorithm on the Quality of Care Provided to Older Adults With Dementia in Primary Care Settings
- ClinicalTrials.gov ID
- NCT01548053
- Acronym / sponsor ID
- PC-DATA / PC-DATA1
- Conditions
- Dementia, Alzheimer's Disease
- Keywords
- Primary care, Dementia, Knowledge translation, Quality of care, Qualitative methods, Alzheimer's disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Mar 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 8 Mar 2012 (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.
Alzheimer's disease (AD) and related forms of dementia currently affect over 400,000 individuals in Canada and the numbers of community dwelling older adults with AD is rapidly growing. AD is associated with over $15 billion annually in care costs. Most individuals with AD are under the care of primary care providers (PCPs) including family physicians and primary care nurses. The evaluation and management of AD is challenging for PCPs and the quality of care provided to older adults with AD by PCP could be improved which would optimize outcomes for this vulnerable population. Provision of quality care to older adults with AD involves implementation of best practices as outlined in guidelines such as the Canadian Consensus Conference Guidelines on the Diagnosis and Treatment of Dementia. Utilizing a group of dementia researchers, PCPs, other knowledge users, and individuals affected by AD, this project will develop practical, clinically relevant resources for primary care physicians and nurses to aid in the evaluation of older adults with AD. A knowledge tool, the Primary Care - Dementia Assessment and Treatment Algorithm (DATA Tool) will be introduced into several primary care settings in Ontario using educational sessions with PCP with additional support from internet resource and a dementia care manager. The quality of dementia care provided to older adults newly diagnosed with AD will be assessed in the three years preceding the intervention compared to the year following the implementation. This project will also describe the process of knowledge exchange with PCPs, including potential barriers and facilitators of knowledge uptake and examine if the care provided during the intervention was patient-centred through interviews with patients and caregivers.
Research Objectives:
- Develop knowledge tools to facilitate assessment and treatment of AD by PCPs based on best evidence;
- Transfer these knowledge tools into a variety of primary care settings in Ontario; and,
- Evaluate the effects of this intervention on dementia quality of care, PCP application of knowledge, and the patient-centeredness of care.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PC-DATA toolThe implementation plan consists of educational sessions and a dementia care manager (DCM). The educational sessions consist of two components: a 1.5 hour group-based DATA tool implementation workshop with primary care providers (PCPs); and, a 1 hour follow-up session at study mid-point. The DCM will facilitate application of the DATA tool and provide direct support to PCPs during the study. | Other | – |
Primary outcome
Change in number of dementia care process quality indicators achieved.
Time frame: 1 year following implementation
The evaluation of quality indicators (QI) using chart audit data will be undertaken following initial assessment of dementia will be used to assess the quality of care provided to individuals with dementia. The change in number of QI satisfied following the intervention will be compared to a historical group of individuals assessed for dementia by each PCP in the 3 years preceding the intervention.
2 secondary outcomes
Impact on learning and knowledge application
Time frame: Approximately 9 months following intervention
Client-centred care
Time frame: Approximately 9 months following intervention
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 14 Apr 2017.
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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.
Dallas P Seitz, MD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PC-DATA tool in people with Dementia and Alzheimer's Disease, run by Queen's University 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?
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 14 Apr 2017. 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?
Change in number of dementia care process quality indicators achieved. (time frame: 1 year following implementation). 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 14 Apr 2017; AzTrials last refreshed its copy on 29 Oct 2026.