Clinical trial NCT01819714: Sensory Support Care for Elderly Patients Suffering From Alzheimer'S-type Neurodegenerative Disease
Official title: Evaluation of the Impact of Care Based on Sensory Support for Elderly Patients Suffering From Alzheimer'S-type Neurodegenerative Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Keywords: Snoezelen
Multi-sensorial care session
Alzheimer's-type neurodegenerative disease
Dementia
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2013-03-28
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in NPI-Q scores
timeFrame: 3 months
Secondary outcomes:
measure: Change from baseline in NPI-Q scores
timeFrame: 1 month
measure: Change from baseline in NPI-Q scores
timeFrame: 6 months
measure: Change from baseline in NPI-Q scores
timeFrame: 12 months
measure: Change from baseline in the Quality-of-life-Alzheimer's Disease questionnaire (QOL-AD)
timeFrame: 12 months
measure: Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire
timeFrame: 1 month
measure: Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire
timeFrame: 3 months
measure: Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire
timeFrame: 6 months
measure: Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire
timeFrame: 12 months
measure: Change in drug consumption from baseline
timeFrame: 1 month
measure: Change in drug consumption from baseline
timeFrame: 3 months
measure: Change in drug consumption from baseline
timeFrame: 6 months
measure: Change in drug consumption from baseline
timeFrame: 12 months
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nîmes - Centre de Gérontologie de Serre Cavalier
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Jane Debuysschere, IDE
role: STUDY_DIRECTOR
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Jean-Marie Cros, MD
role: PRINCIPAL_INVESTIGATOR
References: