Comparison for the Patient With Alzheimer Disease the Impact of Three Different Groups of Patient Care (COMPARSE)
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
respite platform
Day care
No access to a respite structure
Sponsored by
About this trial
This is an interventional health services research trial for Alzheimer Disease
Eligibility 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:
-
Sites / Locations
- Le Duff
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
D
C
B
Arm Description
Impact of the day care on health profit of patient
No access to a respite structure
Respite platform
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Efficacity of the different structures
Assess autonomy level of patient Realize sociological qualitative analysis and economic evaluation by comparing differents structures
Full Information
NCT ID
NCT01639586
First Posted
March 23, 2012
Last Updated
March 20, 2023
Sponsor
Department of Clinical Research and Innovation
1. Study Identification
Unique Protocol Identification Number
NCT01639586
Brief Title
Comparison for the Patient With Alzheimer Disease the Impact of Three Different Groups of Patient Care
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 2011 (Actual)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Department of Clinical Research and Innovation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
360 (Actual)
8. Arms, Groups, and Interventions
Arm Title
D
Arm Type
Active Comparator
Arm Description
Impact of the day care on health profit of patient
Arm Title
C
Arm Type
Active Comparator
Arm Description
No access to a respite structure
Arm Title
B
Arm Type
Active Comparator
Arm Description
Respite platform
Intervention Type
Behavioral
Intervention Name(s)
respite platform
Intervention Description
Impact of the respite platform patient care on health profit
Intervention Type
Behavioral
Intervention Name(s)
Day care
Intervention Description
Impact of the day care on health profit of patient
Intervention Type
Behavioral
Intervention Name(s)
No access to a respite structure
Intervention Description
Control group without access to a respite structure
Primary Outcome Measure Information:
Title
Analysis of the perceived and diagnosed health evolution of the patient
Description
Realize neuropsychological evaluation and satisfaction degree evaluation of the patient and the informal caregiver to compare different types of respite care structures
Time Frame
at baseline, one month and nine month
Secondary Outcome Measure Information:
Title
Efficacity of the different structures
Description
Assess autonomy level of patient Realize sociological qualitative analysis and economic evaluation by comparing differents structures
Time Frame
at baseline, one month and nine month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Pradier, PHD MD
Organizational Affiliation
Département de Santé Publique - CHU de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Le Duff
City
Nice
ZIP/Postal Code
06000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Comparison for the Patient With Alzheimer Disease the Impact of Three Different Groups of Patient Care
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