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

April 28, 2015 updated by: Centre Hospitalier Universitaire de Nīmes

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nîmes, France, 30029
        • CHU de Nîmes - Centre de Gérontologie de Serre Cavalier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study population
Patients hospitalized at the Serre-Cavalier centre and who have Alzheimer's-type neurodegenerative disease (see inclusion criteria).
Other: 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.

Other Names:
  • Snoezelen-type care
  • Snoezelen toilette

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in NPI-Q scores
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in NPI-Q scores
Time Frame: 1 month
1 month
Change from baseline in NPI-Q scores
Time Frame: 6 months
6 months
Change from baseline in NPI-Q scores
Time Frame: 12 months
12 months
Change from baseline in the Quality-of-life-Alzheimer's Disease questionnaire (QOL-AD)
Time Frame: 12 months
12 months
Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire
Time Frame: 1 month
1 month
Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire
Time Frame: 3 months
3 months
Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire
Time Frame: 6 months
6 months
Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire
Time Frame: 12 months
12 months
Change in drug consumption from baseline
Time Frame: 1 month
1 month
Change in drug consumption from baseline
Time Frame: 3 months
3 months
Change in drug consumption from baseline
Time Frame: 6 months
6 months
Change in drug consumption from baseline
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Investigators

  • Study Director: Jane Debuysschere, IDE, Centre Hospitalier Universitaire de Nîmes
  • Principal Investigator: Jean-Marie Cros, MD, Centre Hospitalier Universitaire de Nîmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

March 25, 2013

First Submitted That Met QC Criteria

March 25, 2013

First Posted (Estimate)

March 28, 2013

Study Record Updates

Last Update Posted (Estimate)

April 29, 2015

Last Update Submitted That Met QC Criteria

April 28, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHRIP/2012/JD
  • 2013-A00005-40 (Other Identifier: RCB number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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