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Completed

NCT Number: NCT01819714

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

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nîmes - Centre de Gérontologie de Serre Cavalier

Nîmes, 30029, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multi-sensory supportive care

Other

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

Primary outcomes

  1. Change from baseline in NPI-Q scores

    Time frame: 3 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: SensiCare

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Mar 28, 2013
Registry last updated
Apr 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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