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

Primary Purpose

Alzheimer Disease

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Multi-sensory supportive care

About this trial

This is an interventional supportive care trial for Alzheimer Disease focused on measuring Snoezelen, Multi-sensorial care session, Alzheimer's-type neurodegenerative disease, Dementia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CHU de Nîmes - Centre de Gérontologie de Serre Cavalier

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study population

Arm Description

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

Outcomes

Primary Outcome Measures

Change from baseline in NPI-Q scores

Secondary Outcome Measures

Change from baseline in NPI-Q scores

Change from baseline in the Quality-of-life-Alzheimer's Disease questionnaire (QOL-AD)

Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire

Change in drug consumption from baseline

Full Information

NCT ID

NCT01819714

First Posted

March 25, 2013

Last Updated

April 28, 2015

Sponsor

Centre Hospitalier Universitaire de Nīmes

1. Study Identification

Unique Protocol Identification Number

NCT01819714

Brief Title

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

Acronym

SensiCare

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

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

June 2013 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Nīmes

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease

Keywords

Snoezelen, Multi-sensorial care session, Alzheimer's-type neurodegenerative disease, Dementia

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study population

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Multi-sensory supportive care

Other Intervention Name(s)

Snoezelen-type care, Snoezelen toilette

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change from baseline in NPI-Q scores

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Change from baseline in NPI-Q scores

Time Frame

1 month

Title

Change from baseline in NPI-Q scores

Time Frame

6 months

Title

Change from baseline in NPI-Q scores

Time Frame

12 months

Title

Change from baseline in the Quality-of-life-Alzheimer's Disease questionnaire (QOL-AD)

Time Frame

12 months

Title

Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire

Time Frame

1 month

Title

Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire

Time Frame

3 months

Title

Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire

Time Frame

6 months

Title

Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire

Time Frame

12 months

Title

Change in drug consumption from baseline

Time Frame

1 month

Title

Change in drug consumption from baseline

Time Frame

3 months

Title

Change in drug consumption from baseline

Time Frame

6 months

Title

Change in drug consumption from baseline

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jane Debuysschere, IDE

Organizational Affiliation

Centre Hospitalier Universitaire de Nîmes

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Jean-Marie Cros, MD

Organizational Affiliation

Centre Hospitalier Universitaire de Nîmes

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU de Nîmes - Centre de Gérontologie de Serre Cavalier

City

Nîmes

ZIP/Postal Code

30029

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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