NCT01639586

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable alzheimer-disease

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 12, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

1.2 years

First QC Date

March 23, 2012

Last Update Submit

March 20, 2023

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Efficacity of the different structures

    at baseline, one month and nine month

Study Arms (3)

D

ACTIVE COMPARATOR

Impact of the day care on health profit of patient

Behavioral: Day care

C

ACTIVE COMPARATOR

No access to a respite structure

Behavioral: No access to a respite structure

B

ACTIVE COMPARATOR

Respite platform

Behavioral: respite platform

Interventions

respite platformBEHAVIORAL

Impact of the respite platform patient care on health profit

B
Day careBEHAVIORAL

Impact of the day care on health profit of patient

D
No access to a respite structureBEHAVIORAL

Control group without access to a respite structure

C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Le Duff

Nice, 06000, France

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Day Care, Medical

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Christian Pradier, PHD MD

    Département de Santé Publique - CHU de Nice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Department of Clinical Research and Innovation (drc)

Study Record Dates

First Submitted

March 23, 2012

First Posted

July 12, 2012

Study Start

August 1, 2011

Primary Completion

October 1, 2012

Study Completion

April 1, 2013

Last Updated

March 22, 2023

Record last verified: 2023-03

Locations

FR(1)