NCT01819714

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable alzheimer-disease

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

April 29, 2015

Status Verified

April 1, 2015

Enrollment Period

11 months

First QC Date

March 25, 2013

Last Update Submit

April 28, 2015

Conditions

Alzheimer Disease

Keywords

SnoezelenMulti-sensorial care sessionAlzheimer's-type neurodegenerative diseaseDementia

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in NPI-Q scores

    3 months

Secondary Outcomes (12)

  • Change from baseline in NPI-Q scores

    1 month

  • Change from baseline in NPI-Q scores

    6 months

  • Change from baseline in NPI-Q scores

    12 months

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

    12 months

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

    1 month

  • +7 more secondary outcomes

Study Arms (1)

Study population

EXPERIMENTAL

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

Other: Multi-sensory supportive care

Interventions

Multi-sensory supportive careOTHER

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.

Also known as: Snoezelen-type care, Snoezelen toilette
Study population

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nîmes - Centre de Gérontologie de Serre Cavalier

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Alzheimer DiseaseDementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Jane Debuysschere, IDE

    Centre Hospitalier Universitaire de Nîmes

    STUDY DIRECTOR

  • Jean-Marie Cros, MD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2013

First Posted

March 28, 2013

Study Start

June 1, 2013

Primary Completion

May 1, 2014

Study Completion

February 1, 2015

Last Updated

April 29, 2015

Record last verified: 2015-04

Locations

FR(1)