Comparison for the Patient With Alzheimer Disease the Impact of Three Different Groups of Patient Care (COMPARSE)

Comparaison du Service Rendu à la Personne Atteinte d'Une Maladie d'Alzheimer et de l'Aidant Par Trois Types de Prises en Charge (Plateforme, Accueil de Jour et Groupe contrôle

One of the interests of the Alzheimer Plan 2008-2010 is to provide increase support to helping families. It's also of major to involve the patient in the most active treatment possible, encouraging social inter relationship as well as cognitive and behavioural stimulation activities.

In the frame of non drug related approaches to Alzheimer disease (AD), several research projects and actions have already been conducted, but no specific study concerning the efficiency of different types of respite care structures have been conducted so far in France. The present project concerns the thematic of the frame "Development and diversification of respite care structures".

A platform is defined in the Alzheimer Plan as a "diversified range of despite structures according to patients' needs and informal caregivers' expectations" providing several objectives:

Two objectives targeting the informal caregivers:

• offer spare time or tutored
• inform, support and accompany

Two objectives targeting the patients:

• encourage maintain of the patient social life and relationships and work together towards his/her psychological and emotional well-being
• contribute to improve functional cognitive and sensory capacities

The study COMPARSE suggests to compare for the patient - informal caregiver couple, the impact of three different groups of patient care on health profit; resit platform (P), the day care group (D), the control group without access to a respite structure (C).

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease
• Intervention / Treatment: Behavioral: Day care; Behavioral: No access to a respite structure; Behavioral: respite platform

• Study Type: Interventional
• Enrollment (Actual): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Franck Le Duff, MD; Phone Number: 04 92 03 47 70; Email: leduff.f@chu-nice.fr
• Study Contact Backup: Name: Lauriane Garcia, Clinical Research Associate; Phone Number: 04 92 03 47 70; Email: garcia.l@chu-nice.fr

Study Locations

• France
  • Nice, France, 06000
    • Le Duff

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria

• patient affect by Alzheimer disease or related pathology
• patient with an informal caregiver
• patient not using any respite structure
• signed informed consent (patient and informal caregiver)
• affiliate to social security

Exclusion criteria

• patient without informal caregiver
• patient include in another clinical protocol

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: D; Impact of the day care on health profit of patient	Behavioral: Day care; Impact of the day care on health profit of patient
Active Comparator: C; No access to a respite structure	Behavioral: No access to a respite structure; Control group without access to a respite structure
Active Comparator: B; Respite platform	Behavioral: respite platform; Impact of the respite platform patient care on health profit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of the perceived and diagnosed health evolution of the patient	Realize neuropsychological evaluation and satisfaction degree evaluation of the patient and the informal caregiver to compare different types of respite care structures	at baseline, one month and nine month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacity of the different structures	Assess autonomy level of patient Realize sociological qualitative analysis and economic evaluation by comparing differents structures	at baseline, one month and nine month

Collaborators and Investigators

• Sponsor: Department of Clinical Research and Innovation
• Investigators: Principal Investigator: Christian Pradier, PHD MD, Département de Santé Publique - CHU de Nice

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2011
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: March 23, 2012
• First Submitted That Met QC Criteria: July 10, 2012
• First Posted (Estimate): July 12, 2012

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 20, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: 2011-A00167-34