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

Alzheimer's Disease Clinical Trial

— EvaMMADom  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03360552
• Other study ID #: 2016-54
• Secondary ID: 2017-A01582-51
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2019
• Est. completion date: January 15, 2026

Study information

• Verified date: August 2021
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Mattieu CECCALDI, PU-PH
• Phone: 491385928
• Email: mathieu.ceccaldi[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: January 15, 2026
• Est. primary completion date: January 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Other:
• Multidimensional fragility index questionnaire RAI-Home Care
Questionnaire for assessing deficits in Alzheimer's disease
• Usual care
Usual clinical evaluation

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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