Non Pharmacological Management of Behavioural Symptoms in... | NCT00824967

Studies
Non Pharmacological Management of Behavioural Symptoms in Nursing Home

NCT00824967

Sponsor

Centre Hospitalier Universitaire de Nice

Status

Terminated

Last Update Posted

Mar 26, 2012Estimated

Enrollment

306Actual

Phase

Not Applicable

Conditions

ALZHEIMER Disease

Interventions

Training and valuation of the treating personnel

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Oct 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

Jan 16, 2009

First Submission Date that Met QC Criteria

Jan 16, 2009

First Posted Date

Jan 19, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2012

Last Update Posted Date

Mar 26, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

306Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Training and valuation of the treating personnel	Other	Training and valuation of the treating personnel	2- The intervention group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes at the behavioural assessment (CMAI, OS, NPI) after 8 weeks of intervention		8 weeks after intervention

Secondary Outcomes

Measure	Description	Time Frame
Changes at the behavioural assessment (CMAI, OS, NPI) 16 weeks after the end of the intervention		16 weeks after intervention

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Alzheimer disease

Exclusion Criteria:

Not alzheimer disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Philippe ROBERT, PhD	CHU de Nice - CM2R - Hôpital de Cimiez - 4 avenue reine victoria - 06 003 Nice cedex 1	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Nice - 4 avenue Reine Victoria		Nice	Alpes-Maritimes	06001	France

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided