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

NCT ID: NCT01819714

Last Updated: 2015-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-02-28

Brief Summary

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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

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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

Conditions

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Alzheimer Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Study population

Patients hospitalized at the Serre-Cavalier centre and who have Alzheimer's-type neurodegenerative disease (see inclusion criteria).

Group Type EXPERIMENTAL

Multi-sensory supportive care

Intervention Type OTHER

The Serre-Cavalier center will implement Snoezelen-type multisensory care sessions for included patients; these care sessions correspond with the patients' daily hygiene/toilette care.

The impact of this multisensory strategy will be evaluated using a before-after design.

Interventions

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Multi-sensory supportive care

The Serre-Cavalier center will implement Snoezelen-type multisensory care sessions for included patients; these care sessions correspond with the patients' daily hygiene/toilette care.

The impact of this multisensory strategy will be evaluated using a before-after design.

Intervention Type OTHER

Other Intervention Names

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Snoezelen-type care Snoezelen toilette

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jane Debuysschere, IDE

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire de Nîmes

Jean-Marie Cros, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

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CHU de Nîmes - Centre de Gérontologie de Serre Cavalier

Nîmes, , France

Site Status

Countries

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France

Other Identifiers

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2013-A00005-40

Identifier Type: OTHER

Identifier Source: secondary_id

PHRIP/2012/JD

Identifier Type: -

Identifier Source: org_study_id

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