Evaluating the Effectiveness of a New Way of Organizing Primary Health Care to Improve the Management of Alzheimer's Disease (EvaMMADom)
Primary Purpose
Alzheimer's Disease
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Multidimensional fragility index questionnaire RAI-Home Care
Usual care
Sponsored by
About this trial
This is an interventional supportive care trial for Alzheimer's Disease
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Assistance Publique Hôpitaux de MarseilleRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
the multidimensional score of fragility (RAI CA)
Usual care
Arm Description
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.
support for patients without multidimensional evaluation (RAI-CA)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03360552
First Posted
November 28, 2017
Last Updated
August 17, 2021
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT03360552
Brief Title
Evaluating the Effectiveness of a New Way of Organizing Primary Health Care to Improve the Management of Alzheimer's Disease
Acronym
EvaMMADom
Official Title
Evaluating the Effectiveness of a New Way of Organizing Primary Health Care to Improve the Management of Alzheimer's Disease EvaMMADom
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 16, 2019 (Actual)
Primary Completion Date
January 15, 2026 (Anticipated)
Study Completion Date
January 15, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
320 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
the multidimensional score of fragility (RAI CA)
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
Placebo Comparator
Arm Description
support for patients without multidimensional evaluation (RAI-CA)
Intervention Type
Other
Intervention Name(s)
Multidimensional fragility index questionnaire RAI-Home Care
Intervention Description
Questionnaire for assessing deficits in Alzheimer's disease
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Usual clinical evaluation
Primary Outcome Measure Information:
Title
Assessment of multidimensional fragility scores
Description
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
Time Frame
20 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mattieu CECCALDI, PU-PH
Phone
491385928
Ext
+33
Email
mathieu.ceccaldi@ap-hm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Olivier ARNAUD, Director
Phone
491381475
Ext
+33
Email
drci@ap-hm.fr
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu CECCALDI, PU-PH
Phone
491385928
Ext
+33
Email
mathieu.ceccaldi@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Mathieu CECCALDI, PU-PH
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluating the Effectiveness of a New Way of Organizing Primary Health Care to Improve the Management of Alzheimer's Disease
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