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

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Enrolling

Conditions: Alzheimer's Disease

Treatments: Other: Multidimensional fragility index questionnaire RAI-Home Care; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT03360552

2016-54

2017-A01582-51 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 320 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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320 participants in 2 patient groups, including a placebo group

the multidimensional score of fragility (RAI CA)

Experimental group

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.

Treatment:

Other: Multidimensional fragility index questionnaire RAI-Home Care

Usual care

Placebo Comparator group

Description:

support for patients without multidimensional evaluation (RAI-CA)

Treatment:

Other: Usual care