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Non Pharmacological Management of Behavioural Symptoms in Nursing Home
This study is ongoing, but not recruiting participants.
First Received: January 16, 2009   No Changes Posted
Sponsored by: Centre Hospitalier Universitaire de Nice
Information provided by: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT00824967
  Purpose

Background: Behavioural and psychological symptoms of dementia (BPSD) are often reported in institutions for the elderly.

Objective: To evaluate the effectiveness of a staff education intervention to manage BPSD in older people with a diagnosis of dementia.


Condition Intervention
Alzheimer Disease
Other: Training and valuation of the treating personnel

Genetics Home Reference related topics: Alzheimer disease
MedlinePlus related topics: Alzheimer's Disease Dementia
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Open Label, Uncontrolled, Parallel Assignment
Official Title: Not Pharmacologic Treatment Has Illness of Alzheimer and Pathologies Related. Application in Disturbances of Behaviour in EHPAD

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

Primary Outcome Measures:
  • Changes at the behavioural assessment (CMAI, OS, NPI) after 8 weeks of intervention [ Time Frame: 8 weeks after intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes at the behavioural assessment (CMAI, OS, NPI) 16 weeks after the end of the intervention [ Time Frame: 16 weeks after intervention ] [ Designated as safety issue: No ]

Enrollment: 306
Study Start Date: October 2007
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1- The reference group: No Intervention
one will take care of the patient in a habitual way: no consultation additional, step of exam on top of that...
2- The intervention group
Training and valuation of the treating personnel
Other: Training and valuation of the treating personnel
Training and valuation of the treating personnel

Detailed Description:

Background: Behavioural and psychological symptoms of dementia (BPSD) are often reported in institutions for the elderly.

Objective: To evaluate the effectiveness of a staff education intervention to manage BPSD in older people with a diagnosis of dementia.

Methods: The trial was conducted in 16 nursing homes; 306 patients with a diagnosis of dementia and presenting BPSD were selected. Nursing homes were randomly allocated to an intervention group or a control group. An eight-week staff education and training programme was conducted in the nursing homes in the intervention group. The main outcome measures were the Cohen-Mansfield Agitation Inventory (CMAI) and an observation scale score. Assessments were done at baseline (W0), at the end of the 'intervention' period (W8) and 12 weeks after (W20).

  Eligibility

Ages Eligible for Study:   60 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Alzheimer disease

Exclusion Criteria:

  • Not alzheimer disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00824967

Locations
France, Alpes-Maritimes
CHU de Nice - 4 avenue Reine Victoria
Nice, Alpes-Maritimes, France, 06001
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Philippe ROBERT, PhD CHU de Nice - CM2R - Hôpital de Cimiez - 4 avenue reine victoria - 06 003 Nice cedex 1
  More Information

No publications provided

Responsible Party: CHU de Nice ( CAILLON )
Study ID Numbers: 07-PP-03
Study First Received: January 16, 2009
Last Updated: January 16, 2009
ClinicalTrials.gov Identifier: NCT00824967     History of Changes
Health Authority: France: National Consultative Ethics Committee for Health and Life Sciences

Study placed in the following topic categories:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium
Behavioral Symptoms

Additional relevant MeSH terms:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on May 07, 2009