Evaluating the Effectiveness of a New Way of Organizing Primary Health Care to Improve the Management of Alzheimer's Disease (EvaMMADom)

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.

Study Overview

• Status: Recruiting
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Other: Multidimensional fragility index questionnaire RAI-Home Care; Other: Usual care

• Study Type: Interventional
• Enrollment (Anticipated): 320
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mattieu CECCALDI, PU-PH; Phone Number: +33 491385928; Email: mathieu.ceccaldi@ap-hm.fr
• Study Contact Backup: Name: Jean-Olivier ARNAUD, Director; Phone Number: +33 491381475; Email: drci@ap-hm.fr

Study Locations

• France
  • Marseille, France, 13354
    • Recruiting
    • Assistance Publique Hopitaux de Marseille
    • Contact: Mathieu CECCALDI, PU-PH; Phone Number: +33 491385928; Email: mathieu.ceccaldi@ap-hm.fr
    • Principal Investigator: Mathieu CECCALDI, PU-PH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the multidimensional score of fragility (RAI CA); 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.	Other: Multidimensional fragility index questionnaire RAI-Home Care; Questionnaire for assessing deficits in Alzheimer's disease
Placebo Comparator: Usual care; support for patients without multidimensional evaluation (RAI-CA)	Other: Usual care; Usual clinical evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	20 months

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2019
• Primary Completion (Anticipated): January 15, 2026
• Study Completion (Anticipated): January 15, 2026

Study Registration Dates

• First Submitted: November 28, 2017
• First Submitted That Met QC Criteria: November 28, 2017
• First Posted (Actual): December 4, 2017

Study Record Updates

• Last Update Posted (Actual): August 24, 2021
• Last Update Submitted That Met QC Criteria: August 17, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: 2016-54; 2017-A01582-51 (Registry Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No