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

Alzheimer Disease Clinical Trial

— COMPARSE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01639586
• Other study ID #: 2011-A00167-34
• Status: Completed
• Phase: N/A
• Start date: August 2011
• Est. completion date: April 2013

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: April 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Behavioral:
• respite platform
Impact of the respite platform patient care on health profit
• Day care
Impact of the day care on health profit of patient
• No access to a respite structure
Control group without access to a respite structure

Locations

Country	Name	City	State
France	Le Duff	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Department of Clinical Research and Innovation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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