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

This study is currently recruiting participants.
Verified July 2012 by Centre Hospitalier Universitaire de Nice
Sponsor:
Information provided by (Responsible Party):
Department of Clinical Research and Innovation, Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01639586
First received: March 23, 2012
Last updated: July 10, 2012
Last verified: July 2012
  Purpose

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).


Condition Intervention
Alzheimer Disease
Behavioral: respite platform
Behavioral: Day care
Behavioral: No access to a respite structure

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • Analysis of the perceived and diagnosed health evolution of the patient [ Time Frame: at baseline, one month and nine month ] [ Designated as safety issue: No ]
    Realize neuropsychological evaluation and satisfaction degree evaluation of the patient and the informal caregiver to compare different types of respite care structures


Secondary Outcome Measures:
  • Efficacity of the different structures [ Time Frame: at baseline, one month and nine month ] [ Designated as safety issue: No ]
    Assess autonomy level of patient Realize sociological qualitative analysis and economic evaluation by comparing differents structures


Estimated Enrollment: 360
Study Start Date: August 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01639586

Contacts
Contact: Franck Le Duff, MD 04 92 03 47 70 leduff.f@chu-nice.fr
Contact: Lauriane Garcia, Clinical Research Associate 04 92 03 47 70 garcia.l@chu-nice.fr

Locations
France
Le Duff Recruiting
Nice, France, 06000
Principal Investigator: Franck Le Duff, MD         
Sponsors and Collaborators
Department of Clinical Research and Innovation
Investigators
Principal Investigator: Christian Pradier, PHD MD Département de Santé Publique - CHU de Nice
  More Information

No publications provided

Responsible Party: Department of Clinical Research and Innovation, Department of Clinical Research and Innovation (drc), Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01639586     History of Changes
Other Study ID Numbers: 2011-A00167-34
Study First Received: March 23, 2012
Last Updated: July 10, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes
France: French Data Protection Authority

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014