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

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

Tracking Information

• First Submitted Date: November 28, 2017
• First Posted Date: December 4, 2017
• Last Update Posted Date: August 24, 2021
• Actual Study Start Date: January 16, 2019
• Estimated Primary Completion Date: January 15, 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 28, 2017)

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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluating the Effectiveness of a New Way of Organizing Primary Health Care to Improve the Management of Alzheimer's Disease
• Official Title: Evaluating the Effectiveness of a New Way of Organizing Primary Health Care to Improve the Management of Alzheimer's Disease EvaMMADom
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Supportive Care
• Condition: Alzheimer's Disease

Intervention

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

Study Arms

• 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.
  Intervention: Other: Multidimensional fragility index questionnaire RAI-Home Care
• Placebo Comparator: Usual care
  support for patients without multidimensional evaluation (RAI-CA)
  Intervention: Other: Usual care

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: November 28, 2017): 320
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 15, 2026
• Estimated Primary Completion Date: January 15, 2026 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 65 Years and older (Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: France

Administrative Information

• NCT Number: NCT03360552
• Other Study ID Numbers: 2016-54; 2017-A01582-51 ( Registry Identifier: IDRCB )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Assistance Publique Hopitaux De Marseille
• Original Responsible Party: Same as current
• Current Study Sponsor: Assistance Publique Hopitaux De Marseille
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Assistance Publique Hopitaux De Marseille
• Verification Date: August 2021