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

NCT ID: NCT01639586

Last Updated: 2023-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-04-30

Brief Summary

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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).

Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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D

Impact of the day care on health profit of patient

Group Type ACTIVE_COMPARATOR

Day care

Intervention Type BEHAVIORAL

Impact of the day care on health profit of patient

C

No access to a respite structure

Group Type ACTIVE_COMPARATOR

No access to a respite structure

Intervention Type BEHAVIORAL

Control group without access to a respite structure

B

Respite platform

Group Type ACTIVE_COMPARATOR

respite platform

Intervention Type BEHAVIORAL

Impact of the respite platform patient care on health profit

Interventions

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respite platform

Impact of the respite platform patient care on health profit

Intervention Type BEHAVIORAL

Day care

Impact of the day care on health profit of patient

Intervention Type BEHAVIORAL

No access to a respite structure

Control group without access to a respite structure

Intervention Type BEHAVIORAL

Eligibility Criteria

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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


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Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Department of Clinical Research and Innovation

OTHER

Sponsor Role lead

Responsible Party

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Department of Clinical Research and Innovation

Department of Clinical Research and Innovation (drc)

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Christian Pradier, PHD MD

Role: PRINCIPAL_INVESTIGATOR

Département de Santé Publique - CHU de Nice

Locations

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Le Duff

Nice, , France

Site Status

Countries

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France

Other Identifiers

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2011-A00167-34

Identifier Type: -

Identifier Source: org_study_id

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