NCT00824967

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
306

participants targeted

Target at P75+ for not_applicable alzheimer-disease

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 19, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

March 26, 2012

Status Verified

January 1, 2009

Enrollment Period

2 years

First QC Date

January 16, 2009

Last Update Submit

March 23, 2012

Conditions

ALZHEIMER Disease

Outcome Measures

Primary Outcomes (1)

  • Changes at the behavioural assessment (CMAI, OS, NPI) after 8 weeks of intervention

    8 weeks after intervention

Secondary Outcomes (1)

  • Changes at the behavioural assessment (CMAI, OS, NPI) 16 weeks after the end of the intervention

    16 weeks after intervention

Study Arms (2)

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

OTHER

Training and valuation of the treating personnel

Other: Training and valuation of the treating personnel

Interventions

Training and valuation of the treating personnelOTHER

Training and valuation of the treating personnel

2- The intervention group

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Alzheimer disease

You may not qualify if:

  • Not alzheimer disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice - 4 avenue Reine Victoria

Nice, Alpes-Maritimes, 06001, France

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Philippe ROBERT, PhD

    CHU de Nice - CM2R - Hôpital de Cimiez - 4 avenue reine victoria - 06 003 Nice cedex 1

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2009

First Posted

January 19, 2009

Study Start

October 1, 2007

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

March 26, 2012

Record last verified: 2009-01

Locations

FR(1)