Major Neurocognitive DisorderNCT04889794
GPS Project Evaluation of the Impact of the Reorganization of Work Into a Family Medicine Group on Pharmacotherapy and Support for the Autonomy of Seniors With Major Neurocognitive Disorders
A study testing GPS clinical intervention in people with Major Neurocognitive Disorder, run by CHU de Quebec-Universite Laval at 2 sites in Canada.
Trial summary
The model of care tested in the GPS project aims to optimize pharmacotherapy for seniors undergoing cognitive assessment or suffering from major neurocognitive disorder (MCND) at home. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Major Neurocognitive Disorder
- What is being tested?
- GPS clinical intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesCanada
- Study dates
- 27 Sep 2021to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- All seniors (65 years of age or older) undergoing cognitive evaluation OR referred to a memory clinic OR having been diagnosed with cognitive impairment within the last year OR with MCND and followed up at home AND,
- referred to the pharmacist, for the FMGs exposed
- taking prescription medications
Who cannot join
- Seniors in palliative care OR
- unable to answer questionnaires in French AND without a caregiver.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
GMF Bordeaux-Cartierville
Montreal, Quebec, H3M 2X6
Line Guénette, Ph.D, 418-682-7511 ext. 84694, line.guenette@pha.ulaval.ca
- Recruiting
GMF Abénakis
Saint-Georges, Quebec, G5Y 5L6
Line Guénette, Ph.D, 418-682-7511 ext. 84694, line.guenette@pha.ulaval.ca
Edeltraut Kröger, Ph.D
About this study
Official title: GPS Project - Evaluation of the Impact of the Reorganization of Work Into a Family Medicine Group on Pharmacotherapy and Support for the Autonomy of Seniors With Major Neurocognitive Disorders
The model of care tested in the GPS project aims to optimize pharmacotherapy for seniors undergoing cognitive assessment or suffering from major neurocognitive disorder (MCND) at home. The goal is to reduce polymedication, inappropriate medications and the treatment burden of seniors and to maintain their cognitive health, quality of life and autonomy. The intervention will include knowledge exchange sessions with nurses, pharmacists, and doctors in FMGs, and increased collaboration between these professionals and home care services teams. Other goal is to increase the satisfaction of the seniors, their families, and the professionals involved in the GPS project.
Read the detailed description
: The GPS project is part of the desire to keep seniors with major neurocognitive disorder (MCND) in their homes for as long as possible. Medication can contribute to cognitive loss in seniors and affect their functional autonomy. The arrival of pharmacists in FMGs and the expansion of their practice is opening up new opportunities to promote interdisciplinary collaboration and optimize pharmacotherapy for seniors. During the project, a new model of care, called GPS, is being tested with seniors. A group of seniors (approximately 200) will receive the new care team's new interventions in the FMGs in the "intervention" group. Another group of seniors (about 200) will receive the usual care in other FMGs that will serve as a "control" group. By comparing the results of the two groups, it will be possible to evaluate the effects of new interventions. A period of 12 months will be allocated for the inclusion of seniors. The follow-up of each senior will be approximately 6 months.
- Conditions
- Major Neurocognitive Disorder
- Being tested
- GPS clinical intervention
- Keywords
- living lab, major neurocognitive disorder, polypharmacy, health outcomes, pharmacists, home care, family medicine groups, deprescribing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GPS clinical interventionOther
Nurses and doctors in exposed FMGs and home care teams (HCTs) will be asked to refer to the FMG pharmacist all seniors undergoing cognitive evaluation OR referred to a memory clinic OR recently diagnosed with a cognitive disorder, for a complete and critical review of their medication therapy. FMG pharmacists will be asked to conduct an interview with each referred senior and his or her caregiver, if applicable, in order to establish the best possible treatment regimen. They will compare the information collected with another reliable data source (e.g., pharmacy records) in order to perform medication reconciliation and will then evaluate the medication related problems. Pharmacist will establish a care plan and the follow-ups to be carried out with the patient in collaboration with the health care team. There will be no drug or devices tested, it is a human clinical intervention by a pharmacist.
| Study group | Role | What they receive |
|---|---|---|
| Exposed FMGs to GPS intervention | Experimental | Patients who are followed by FMGs exposed to the GPS intervention. They will receive the GPS intervention. Receives: Other: GPS clinical intervention |
| Non exposed FMGs to GPS intervention | No intervention | Patients who are part of the FMGs not exposed to the GPS intervention. They will receive the usual care and services. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of prescribed medications
The total number of prescribed medications and 2) the number of potentially inappropriate medications (PIMs) according to the Beers criteria or according to the OptimaMed criteria for participants with advanced MCND will be measured in both groups, before, during and after the study.
Measured: Baseline, 3 months and 6 months after inclusion in the study.
Secondary outcomes (1)
Change in treatment burden
The treatment burden level will be measured with the 13-item Multimorbidity Treatment burden questionnaire in the intervention and control groups before and after the study. Each item will be scored as follows: zero (not difficult/ does not apply), one (a little difficult), two (quite difficult), three (very difficult), four (extremely difficult).Scores will be interpreted as suggested by the authors of the original MTBQ instrument: no burden (score 0), low burden (score <10), medium burden (10-22), high burden (>=22)
Measured: Baseline and 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start27 Sep 2021
- Primary completionJul 2025 (estimated)
- Study completionDec 2026 (estimated)
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 Major Neurocognitive DisorderStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- CISSS de Chaudière-Appalaches, Ciusss de L'Est de l'Île de Montréal, Fonds de la Recherche en Santé du Québec
- Responsible party
- Principal investigator, Dre Edeltraut Kröger, CHU de Quebec-Universite Laval
- Investigators
- Line Guénette, Ph.D, Study director, CHU de Québec-Université Laval, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889794
- Sponsor's protocol ID
- MP-23-2020-732 - GPS
- Status last verified
- Aug 2024
- First submitted
- 12 May 2021
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guenette L, Kroger E, Bonnan D, Maheu A, Morin M, Belanger L, Vedel I, Wilchesky M, Sirois C, Durand E, Couturier Y, Sourial N, Dallaire C. Reorganizing Pharmaceutical Care in Family Medicine Groups for Older Adults With or at Risk of Major Neurocognitive Disorders: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2022 Nov 17;11(11):e42577. doi: 10.2196/42577.
PubMed 36264995
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GPS Project - Evaluation of the Impact of the Reorganization of Work Into a Family Medicine Group on Pharmacotherapy and Support for the Autonomy of Seniors With Major Neurocognitive Disorders
- ClinicalTrials.gov ID
- NCT04889794
- Acronym / sponsor ID
- MP-23-2020-732 - GPS
- Conditions
- Major Neurocognitive Disorder
- Keywords
- living lab, major neurocognitive disorder, polypharmacy, health outcomes, pharmacists, home care, family medicine groups, deprescribing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- CISSS de Chaudière-Appalaches, Ciusss de L'Est de l'Île de Montréal, Fonds de la Recherche en Santé du Québec
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 May 2021 (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 model of care tested in the GPS project aims to optimize pharmacotherapy for seniors undergoing cognitive assessment or suffering from major neurocognitive disorder (MCND) at home. The goal is to reduce polymedication, inappropriate medications and the treatment burden of seniors and to maintain their cognitive health, quality of life and autonomy. The intervention will include knowledge exchange sessions with nurses, pharmacists, and doctors in FMGs, and increased collaboration between these professionals and home care services teams. Other goal is to increase the satisfaction of the seniors, their families, and the professionals involved in the GPS project.
Detailed description
: The GPS project is part of the desire to keep seniors with major neurocognitive disorder (MCND) in their homes for as long as possible. Medication can contribute to cognitive loss in seniors and affect their functional autonomy. The arrival of pharmacists in FMGs and the expansion of their practice is opening up new opportunities to promote interdisciplinary collaboration and optimize pharmacotherapy for seniors. During the project, a new model of care, called GPS, is being tested with seniors. A group of seniors (approximately 200) will receive the new care team's new interventions in the FMGs in the "intervention" group. Another group of seniors (about 200) will receive the usual care in other FMGs that will serve as a "control" group. By comparing the results of the two groups, it will be possible to evaluate the effects of new interventions. A period of 12 months will be allocated for the inclusion of seniors. The follow-up of each senior will be approximately 6 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed FMGs to GPS intervention | Experimental | Other: GPS clinical interventionPatients who are followed by FMGs exposed to the GPS intervention. They will receive the GPS intervention. |
| Non exposed FMGs to GPS intervention | No intervention | –Patients who are part of the FMGs not exposed to the GPS intervention. They will receive the usual care and services. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- All seniors (65 years of age or older) undergoing cognitive evaluation OR referred to a memory clinic OR having been diagnosed with cognitive impairment within the last year OR with MCND and followed up at home AND,
- referred to the pharmacist, for the FMGs exposed
- taking prescription medications
Key exclusion criteria (2 listed)
- Seniors in palliative care OR
- unable to answer questionnaires in French AND without a caregiver.
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 |
|---|---|---|
| GPS clinical interventionNurses and doctors in exposed FMGs and home care teams (HCTs) will be asked to refer to the FMG pharmacist all seniors undergoing cognitive evaluation OR referred to a memory clinic OR recently diagnosed with a cognitive disorder, for a complete and critical review of their medication therapy. FMG pharmacists will be asked to conduct an interview with each referred senior and his or her caregiver, if applicable, in order to establish the best possible treatment regimen. They will compare the information collected with another reliable data source (e.g., pharmacy records) in order to perform medication reconciliation and will then evaluate the medication related problems. Pharmacist will establish a care plan and the follow-ups to be carried out with the patient in collaboration with the health care team. There will be no drug or devices tested, it is a human clinical intervention by a pharmacist. | Other | Exposed FMGs to GPS intervention |
Primary outcome
Change in number of prescribed medications
Time frame: Baseline, 3 months and 6 months after inclusion in the study.
The total number of prescribed medications and 2) the number of potentially inappropriate medications (PIMs) according to the Beers criteria or according to the OptimaMed criteria for participants with advanced MCND will be measured in both groups, before, during and after the study.
1 secondary outcome
Change in treatment burden
Time frame: Baseline and 6 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Derived from this study: PubMed 36264995Guenette L, Kroger E, Bonnan D, Maheu A, Morin M, Belanger L, Vedel I, Wilchesky M, Sirois C, Durand E, Couturier Y, Sourial N, Dallaire C. Reorganizing Pharmaceutical Care in Family Medicine Groups for Older Adults With or at Risk of Major Neurocognitive Disorders: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2022 Nov 17;11(11):e42577. doi: 10.2196/42577.
Related trials for Major Neurocognitive Disorder
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruiting
Milk Fat Globule Membrane-Enhanced RUTF for Children With Severe Acute Malnutrition
Severe Acute Malnutrition, Cognitive Impairment
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 2
Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab
Depressive Disorder, Major, Inflammation
Not yet recruiting
Virtual Reality to Advance Dementia Care and Quality of Life
Dementia, Agitation
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.
Line Guénette, Ph.D study director
CHU de Québec-Université Laval, Laval University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GPS clinical intervention in people with Major Neurocognitive Disorder, run by CHU de Quebec-Universite Laval at 2 sites 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 2 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: looking for participants now, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Line Guénette, Ph.D (418-682-7511 ext. 84694, line.guenette@pha.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of prescribed medications (time frame: Baseline, 3 months and 6 months after inclusion in the study.). 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 NCT04889794, 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 22 Aug 2024.