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

NCT03360552 | Unknown

• 2 other identifiers: 2016-542017-A01582-51
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Other: Multidimensional fragility index questionnaire RAI-Home Care

Usual care

PLACEBO COMPARATOR

support for patients without multidimensional evaluation (RAI-CA)

Other: Usual care

Interventions

Multidimensional fragility index questionnaire RAI-Home Care OTHER

Questionnaire for assessing deficits in Alzheimer's disease

the multidimensional score of fragility (RAI CA)

Usual care OTHER

Usual clinical evaluation

Usual care

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Mattieu CECCALDI, PU-PH

CONTACT

491385928; mathieu.ceccaldi@ap-hm.fr

Jean-Olivier ARNAUD, Director

CONTACT

491381475; drci@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 4, 2017
• Study Start: January 16, 2019
• Primary Completion: January 15, 2026
• Study Completion: January 15, 2026
• Last Updated: August 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)