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

Alzheimer Disease Clinical Trial

— SensiCare  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01819714
• Other study ID #: PHRIP/2012/JD
• Secondary ID: 2013-A00005-40
• Status: Completed
• Phase: N/A
• First received: March 25, 2013
• Last updated: April 28, 2015
• Start date: June 2013
• Est. completion date: February 2015

Study information

• Verified date: April 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Alzheimer Disease
• Neurodegenerative Diseases

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Nîmes - Centre de Gérontologie de Serre Cavalier	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in NPI-Q scores		3 months	No
Secondary	Change from baseline in NPI-Q scores		1 month	No
Secondary	Change from baseline in NPI-Q scores		6 months	No
Secondary	Change from baseline in NPI-Q scores		12 months	No
Secondary	Change from baseline in the Quality-of-life-Alzheimer's Disease questionnaire (QOL-AD)		12 months	No
Secondary	Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire		1 month	No
Secondary	Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire		3 months	No
Secondary	Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire		6 months	No
Secondary	Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire		12 months	No
Secondary	Change in drug consumption from baseline		1 month	No
Secondary	Change in drug consumption from baseline		3 months	No
Secondary	Change in drug consumption from baseline		6 months	No
Secondary	Change in drug consumption from baseline		12 months	No