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

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ClinicalTrials.gov Identifier: NCT01819714
Recruitment Status : Completed
First Posted : March 28, 2013
Last Update Posted : April 29, 2015
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Alzheimer Disease Other: Multi-sensory supportive care

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of the Impact of Care Based on Sensory Support for Elderly Patients Suffering From Alzheimer'S-type Neurodegenerative Disease
Study Start Date : June 2013
Primary Completion Date : May 2014
Study Completion Date : February 2015


Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Change from baseline in NPI-Q scores [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Change from baseline in NPI-Q scores [ Time Frame: 1 month ]
  2. Change from baseline in NPI-Q scores [ Time Frame: 6 months ]
  3. Change from baseline in NPI-Q scores [ Time Frame: 12 months ]
  4. Change from baseline in the Quality-of-life-Alzheimer's Disease questionnaire (QOL-AD) [ Time Frame: 12 months ]
  5. Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire [ Time Frame: 1 month ]
  6. Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire [ Time Frame: 3 months ]
  7. Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire [ Time Frame: 6 months ]
  8. Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire [ Time Frame: 12 months ]
  9. Change in drug consumption from baseline [ Time Frame: 1 month ]
  10. Change in drug consumption from baseline [ Time Frame: 3 months ]
  11. Change in drug consumption from baseline [ Time Frame: 6 months ]
  12. Change in drug consumption from baseline [ Time Frame: 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01819714


Locations
France
CHU de Nîmes - Centre de Gérontologie de Serre Cavalier
Nîmes, France, 30029
Sponsors and Collaborators
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
More Information

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01819714     History of Changes
Other Study ID Numbers: PHRIP/2012/JD
2013-A00005-40 ( Other Identifier: RCB number )
First Posted: March 28, 2013    Key Record Dates
Last Update Posted: April 29, 2015
Last Verified: April 2015

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Snoezelen
Multi-sensorial care session
Alzheimer's-type neurodegenerative disease
Dementia

Additional relevant MeSH terms:
Alzheimer Disease
Neurodegenerative Diseases
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurocognitive Disorders
Mental Disorders