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

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ClinicalTrials.gov Identifier: NCT03360552
Recruitment Status : Recruiting
First Posted : December 4, 2017
Last Update Posted : August 24, 2021
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Other: Multidimensional fragility index questionnaire RAI-Home Care Other: Usual care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Evaluating the Effectiveness of a New Way of Organizing Primary Health Care to Improve the Management of Alzheimer's Disease EvaMMADom
Actual Study Start Date : January 16, 2019
Estimated Primary Completion Date : January 15, 2026
Estimated Study Completion Date : January 15, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Assessment of multidimensional fragility scores [ Time Frame: 20 months ]
    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


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03360552


Contacts
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Contact: Mattieu CECCALDI, PU-PH 491385928 ext +33 mathieu.ceccaldi@ap-hm.fr
Contact: Jean-Olivier ARNAUD, Director 491381475 ext +33 drci@ap-hm.fr

Locations
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France
Assistance Publique Hôpitaux de Marseille Recruiting
Marseille, France, 13354
Contact: Mathieu CECCALDI, PU-PH    491385928 ext +33    mathieu.ceccaldi@ap-hm.fr   
Principal Investigator: Mathieu CECCALDI, PU-PH         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
More Information
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03360552    
Other Study ID Numbers: 2016-54
2017-A01582-51 ( Registry Identifier: IDRCB )
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: August 24, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders