Completed

SensiCareEvaluation of the Impact of Care Based on Sensory Support for Elderly Patients Suffering From Alzheimer'S-type Neurodegenerative Disease

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What is being tested

Multi-sensory supportive care

Other
Who is being recruted

Mental Disorders+6

+ Brain Diseases

+ Central Nervous System Diseases

Over 18 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: June 2013
See protocol details

Summary

Principal SponsorCentre Hospitalier Universitaire de Nīmes
Last updated: April 29, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2013

Actual date on which the first participant was enrolled.

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

NCT01819714
Principal SponsorCentre Hospitalier Universitaire de Nīmes
Last updated: April 29, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

31 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurodegenerative DiseasesNeurocognitive DisordersTauopathiesAlzheimer DiseaseDementia

Criteria

4 inclusion criteria required to participate
Alzheimer's-type neurodegenerative pathology
The patient has been living in the participating center for > 2 months
The patient must be insured or beneficiary of a health insurance plan
The patient's legal representative must have given his/her informed and signed consent (or the patient if he/she is judged competent)
3 exclusion criteria prevent from participating
It is impossible to correctly inform the patient's legal representative
The patient has already has Snoezelen-therapy
The patient's legal representative refuses to sign the consent (or the patient if he/she is judged competent)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

CHU de Nîmes - Centre de Gérontologie de Serre Cavalier

Nîmes, FranceOpen CHU de Nîmes - Centre de Gérontologie de Serre Cavalier in Google Maps
CompletedOne Study Center