DementiaNCT01441726
Palliative and End-of-life Care in Advanced Dementia: Evaluation of a Program of Organization of Care in Long-term Care
An observational study of Dementia, run by Laval University at 1 site in Canada.
Trial summary
Rationale: In Canada, as in most industrialized countries, Alzheimer's disease and other related dementia are increasingly prevalent in older people. At an advanced stage, institutionalization in a long-term care (LTC) setting will be the fate of a majority of patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia
- How many people
- 175 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2012to Oct 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: Residents in long term care settings
Who may be able to join
- Residents with advanced dementia with a score of 7 on the Reisberg scale
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre de santé et de services sociaux de la Vieille Capitale
Québec, Quebec, G1S 2A4
About this study
Official title: Palliative and End-of-life Care in Advanced Dementia: Evaluation of a Program of Organization of Care in Long-term Care Settings
Rationale: In Canada, as in most industrialized countries, Alzheimer's disease and other related dementia are increasingly prevalent in older people. At an advanced stage, institutionalization in a long-term care (LTC) setting will be the fate of a majority of patients. A structured palliative care approach is increasingly used for cancer patients, but is still rarely accessible in LTC institutions for older people with advanced or terminal dementia. This approach should include a more systematic detection and treatment of pain and other physical and psychological symptoms during the last weeks of life, as well as better communications between patients, families and care staff, particularly relating to advanced care directives. Objectives: The general objective of this study is to implement and evaluate a multidisciplinary and multidimensional program of palliative and end-of-life care for older persons with terminal dementia in LTC facilities. Methodology: The intervention program will include five components:
- daily involvement of a nurse from the regular staff in the LTC facility as a change agent;
- awareness sessions with administrators and staff on the importance of high quality palliative care in dementia;
- a training program for physicians and all the staff involved in direct care of patients;
- systematic discussions with families and distribution to families of a document on different aspects of palliative care in dementia;
- systematic clinical care by regular staff for the control of pain, respiratory symptoms and mouth care. The program will be implemented in two LTC settings (one in Quebec City and one in Sherbrooke, Quebec, Canada), and results will be compared with the LTC control settings where usual care will be applied without implementation of the program.
- Conditions
- Dementia
- Keywords
- Advanced dementia, Quality, Terminal care
- 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 |
|---|---|---|
| Training of staff | Not described | |
| No training of staff | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Family satisfaction with terminal care
Family Perception of Care Scale (FPCS): 25-item validated instrument including 4 components, yielding a score from 25 (negative perception) to 175 (highest positive perception of quality of palliative care)
Measured: 1 year
Comfort scale in last two weeks of life
Comfort Assessment in Dying with Dementia (CAD-EOL): 14-item validated instrument including 4 sub-scales, yielding a score from 14 (low comfort level) to 42 (highest comfort level).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2011 (estimated)
- Study startSep 2012
- Primary completionOct 2014
- Study completionOct 2014
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.
- More trials run by Laval UniversityThe 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
- Time perspective
- Prospective
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, René Verreault, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01441726
- Sponsor's protocol ID
- MOP-114881
- Status last verified
- Mar 2015
- First submitted
- 7 Sep 2011
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliative and End-of-life Care in Advanced Dementia: Evaluation of a Program of Organization of Care in Long-term Care Settings
- ClinicalTrials.gov ID
- NCT01441726
- Acronym / sponsor ID
- MOP-114881
- Conditions
- Dementia
- Keywords
- Advanced dementia, Quality, Terminal care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 28 Sep 2011 (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.
Rationale: In Canada, as in most industrialized countries, Alzheimer's disease and other related dementia are increasingly prevalent in older people. At an advanced stage, institutionalization in a long-term care (LTC) setting will be the fate of a majority of patients. A structured palliative care approach is increasingly used for cancer patients, but is still rarely accessible in LTC institutions for older people with advanced or terminal dementia. This approach should include a more systematic detection and treatment of pain and other physical and psychological symptoms during the last weeks of life, as well as better communications between patients, families and care staff, particularly relating to advanced care directives. Objectives: The general objective of this study is to implement and evaluate a multidisciplinary and multidimensional program of palliative and end-of-life care for older persons with terminal dementia in LTC facilities. Methodology: The intervention program will include five components:
- daily involvement of a nurse from the regular staff in the LTC facility as a change agent;
- awareness sessions with administrators and staff on the importance of high quality palliative care in dementia;
- a training program for physicians and all the staff involved in direct care of patients;
- systematic discussions with families and distribution to families of a document on different aspects of palliative care in dementia;
- systematic clinical care by regular staff for the control of pain, respiratory symptoms and mouth care. The program will be implemented in two LTC settings (one in Quebec City and one in Sherbrooke, Quebec, Canada), and results will be compared with the LTC control settings where usual care will be applied without implementation of the program.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training of staff | – | – |
| No training of staff | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Residents in long term care settings
Key inclusion criteria (1 listed)
- Residents with advanced dementia with a score of 7 on the Reisberg scale
Key exclusion criteria (0 listed)
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
Family satisfaction with terminal care
Time frame: 1 year
Family Perception of Care Scale (FPCS): 25-item validated instrument including 4 components, yielding a score from 25 (negative perception) to 175 (highest positive perception of quality of palliative care)
Comfort scale in last two weeks of life
Time frame: 2 weeks
Comfort Assessment in Dying with Dementia (CAD-EOL): 14-item validated instrument including 4 sub-scales, yielding a score from 14 (low comfort level) to 42 (highest comfort level).
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 31 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Dementia, run by Laval 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?
The sponsor lists 1 inclusion and 0 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 31 Mar 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?
Family satisfaction with terminal care (time frame: 1 year). The study lists 2 primary outcomes in all. 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 31 Mar 2015.