Alzheimer's DiseaseEvaMMADomNCT03360552
Evaluating the Effectiveness of a New Way of Organizing Primary Health Care to Improve the Management of Alzheimer's Disease
A study testing Multidimensional fragility index questionnaire RAI-Home Care in people with Alzheimer's Disease, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The objective of the present study is to evaluate the effectiveness of a general practitioner (MG) management strategy guided by a multidimensional evaluation on the multidimensional score of fragility of patients with mild to moderately severe dementia, compared to those currently implemented (without the provision… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Multidimensional fragility index questionnaire RAI-Home Care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jan 2019to 15 Jan 2026
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients with probable Alzheimer's disease, according to the criteria usually used in memory centers
- Aged over 64 years with mild to moderately severe dementia syndrome
- Volunteers for medical follow-up for a period of 20 months; Which the general practitioner attending agrees to participate in the research
Who cannot join
- Patients under 65 years old
- presenting with early cognitive decline or severe dementia
- Not meeting the clinical diagnostic criteria for Alzheimer's disease
- Refusing or unable to sign informed consent to participate
- Not voluntary for medical follow-up for a period of 20 months
- Whose general practitioner refuses to participate in the research
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpitaux de Marseille
Marseille, 13354
Mathieu CECCALDI, PU-PH, 491385928 ext. +33, mathieu.ceccaldi@ap-hm.fr
Mathieu CECCALDI, PU-PH
About this study
Official title: Evaluating the Effectiveness of a New Way of Organizing Primary Health Care to Improve the Management of Alzheimer's Disease EvaMMADom
The objective of the present study is to evaluate the effectiveness of a general practitioner (MG) management strategy guided by a multidimensional evaluation on the multidimensional score of fragility of patients with mild to moderately severe dementia, compared to those currently implemented (without the provision of such an assessment). The measurement of the respective effectiveness of the two types of care in primary care will itself be based on a multidimensional evaluation performed independently in the memory center having established the diagnosis of Alzheimer's disease. The secondary objectives are the evaluation of the impact of the strategy on the functional abilities of patients, the incidence of geriatric syndromes, cognitive functions, quality of life of the patient and the burden of the primary caregiver. The efficiency of the strategy will be assessed through a cost-effectiveness analysis. A survey of opinions will also be conducted among primary health care providers, carers and CMs on the implemented system.
- Conditions
- Alzheimer's Disease
- Being tested
- Multidimensional fragility index questionnaire RAI-Home Care, Usual care
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidimensional fragility index questionnaire RAI-Home CareOther
Questionnaire for assessing deficits in Alzheimer's disease
Usual careOther
Usual clinical evaluation
| Study group | Role | What they receive |
|---|---|---|
| the multidimensional score of fragility (RAI CA) | Experimental | A general practitioner (MG) management strategy guided by a multidimensional evaluation (RAI-CA) on the multidimensional score of fragility (RAI-HC) of patients with mild to moderately severe dementia. Receives: Other: Multidimensional fragility index questionnaire RAI-Home Care |
| Usual care | Placebo comparator | support for patients without multidimensional evaluation (RAI-CA) Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of multidimensional fragility scores
The multidimensional evaluation score produced by Nurses in the home of AM patients and passed on to patients' doctors increases decision-making and patient care
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start16 Jan 2019
- Primary completion15 Jan 2026 (estimated)
- Study completion15 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360552
- Sponsor's protocol ID
- 2016-54
- Other IDs
- 2017-A01582-51
- Acronym
- EvaMMADom
- Status last verified
- Aug 2021
- First submitted
- 28 Nov 2017
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of a New Way of Organizing Primary Health Care to Improve the Management of Alzheimer's Disease EvaMMADom
- ClinicalTrials.gov ID
- NCT03360552
- Acronym / sponsor ID
- EvaMMADom / 2016-54
- Conditions
- Alzheimer's Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 4 Dec 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 objective of the present study is to evaluate the effectiveness of a general practitioner (MG) management strategy guided by a multidimensional evaluation on the multidimensional score of fragility of patients with mild to moderately severe dementia, compared to those currently implemented (without the provision of such an assessment). The measurement of the respective effectiveness of the two types of care in primary care will itself be based on a multidimensional evaluation performed independently in the memory center having established the diagnosis of Alzheimer's disease. The secondary objectives are the evaluation of the impact of the strategy on the functional abilities of patients, the incidence of geriatric syndromes, cognitive functions, quality of life of the patient and the burden of the primary caregiver. The efficiency of the strategy will be assessed through a cost-effectiveness analysis. A survey of opinions will also be conducted among primary health care providers, carers and CMs on the implemented system.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the multidimensional score of fragility (RAI CA) | Experimental | Other: Multidimensional fragility index questionnaire RAI-Home CareA general practitioner (MG) management strategy guided by a multidimensional evaluation (RAI-CA) on the multidimensional score of fragility (RAI-HC) of patients with mild to moderately severe dementia. |
| Usual care | Placebo comparator | Other: Usual caresupport for patients without multidimensional evaluation (RAI-CA) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patients with probable Alzheimer's disease, according to the criteria usually used in memory centers
- Aged over 64 years with mild to moderately severe dementia syndrome
- Volunteers for medical follow-up for a period of 20 months; Which the general practitioner attending agrees to participate in the research
Key exclusion criteria (6 listed)
- Patients under 65 years old
- presenting with early cognitive decline or severe dementia
- Not meeting the clinical diagnostic criteria for Alzheimer's disease
- Refusing or unable to sign informed consent to participate
- Not voluntary for medical follow-up for a period of 20 months
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 |
|---|---|---|
| Multidimensional fragility index questionnaire RAI-Home CareQuestionnaire for assessing deficits in Alzheimer's disease | Other | the multidimensional score of fragility (RAI CA) |
| Usual careUsual clinical evaluation | Other | Usual care |
Primary outcome
Assessment of multidimensional fragility scores
Time frame: 20 months
The multidimensional evaluation score produced by Nurses in the home of AM patients and passed on to patients' doctors increases decision-making and patient care
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidimensional fragility index questionnaire RAI-Home Care in people with Alzheimer's Disease, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 6 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 24 Aug 2021. 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 France. 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. Some participants in this study may receive a placebo. 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?
Contact Mattieu CECCALDI, PU-PH (491385928 ext. +33, mathieu.ceccaldi@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of multidimensional fragility scores (time frame: 20 months). 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 24 Aug 2021; AzTrials last refreshed its copy on 7 Nov 2026.