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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01819714
First received: March 25, 2013
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

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 Intervention
Alzheimer Disease
Other: Multi-sensory supportive care

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Change from baseline in NPI-Q scores [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in NPI-Q scores [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Change from baseline in NPI-Q scores [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in NPI-Q scores [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in the Quality-of-life-Alzheimer's Disease questionnaire (QOL-AD) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in drug consumption from baseline [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Change in drug consumption from baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Change in drug consumption from baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in drug consumption from baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: June 2013
Estimated Study Completion Date: February 2015
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01819714     History of Changes
Other Study ID Numbers: PHRIP/2012/JD, 2013-A00005-40
Study First Received: March 25, 2013
Last Updated: June 10, 2014
Health Authority: France: Committee for the Protection of Personnes
France: Agence Nationale de Sécurité du Médicament et des produits de santé

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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 22, 2014