Sensory Support Care for Elderly Patients Suffering From Alzheimer'S-type Neurodegenerative Disease

Not Applicable

Completed

• Conditions: Alzheimer Disease

• Registration Number: NCT01819714
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

The main objective of this study is to evaluate the effect of 3 months of "Snoezelen-type" multi-sensory care sessions on NeuroPsychiatric Inventory Questionnaire (NPI-Q) scores for patients with Alzheimer's-type neurodegenerative disease.

Detailed Description

The secondary objectives of this study are to study the following elements in relationship to the implementation of a "Snoezelen-type" multi-sensory care strategy for patients with Alzheimer's-type neurodegenerative disease:

A. to evaluate the effects on NPI-Q scores at 1 month, 6 months and 12 months .

B. evaluate the effects on quality of life (questionnaire QOL-AD) at 0 and 12 months.

C. assess changes in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire over 0, 1, 3, 6 and 12 months.

D. assess changes in drug consumption (anxiolytics, antidepressants, hypnotics, neuroleptics)over the study period

Study Timeline

• Study First Submitted: 2013-03-25
• Study First Submitted QC: 2013-03-25
• Study First Posted: 2013-03-28
• Study Start: 2013-06
• Primary Completion: 2014-05
• Study Completion: 2015-02
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-28
• Last Update Posted: 2015-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• The patient's legal representative must have given his/her informed and signed consent (or the patient if he/she is judged competent)
• The patient must be insured or beneficiary of a health insurance plan
• Alzheimer's-type neurodegenerative pathology
• The patient has been living in the participating center for > 2 months

Exclusion Criteria

• The patient's legal representative refuses to sign the consent (or the patient if he/she is judged competent)
• It is impossible to correctly inform the patient's legal representative
• The patient has already has Snoezelen-therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change from baseline in NPI-Q scores	3 months

Secondary Outcome Measures

Name	Time	Method
Change from baseline in NPI-Q scores	12 months
Change in drug consumption from baseline	12 months
Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire	12 months
Change from baseline in the Quality-of-life-Alzheimer's Disease questionnaire (QOL-AD)	12 months

Trial Locations

Locations (1)

CHU de Nîmes - Centre de Gérontologie de Serre Cavalier; 🇫🇷 Nîmes, France