Non Pharmacological Management of Behavioural Symptoms in Nursing Home

ALZHEIMER Disease Clinical Trial

Official title:

Not Pharmacologic Treatment Has Illness of Alzheimer and Pathologies Related. Application in Disturbances of Behaviour in EHPAD

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00824967
• Other study ID #: 07-PP-03
• Status: Terminated
• Phase: N/A
• First received: January 16, 2009
• Last updated: March 23, 2012
• Start date: October 2007
• Est. completion date: October 2009

Study information

• Verified date: January 2009
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: National Consultative Ethics Committee for Health and Life Sciences
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 306
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 90 Years

Eligibility

Inclusion Criteria:

• Alzheimer disease

Exclusion Criteria:

• Not alzheimer disease

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• ALZHEIMER Disease

Intervention

Other:
• Training and valuation of the treating personnel
Training and valuation of the treating personnel

Locations

Country	Name	City	State
France	CHU de Nice - 4 avenue Reine Victoria	Nice	Alpes-Maritimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes at the behavioural assessment (CMAI, OS, NPI) after 8 weeks of intervention		8 weeks after intervention	No
Secondary	Changes at the behavioural assessment (CMAI, OS, NPI) 16 weeks after the end of the intervention		16 weeks after intervention	No