Non Pharmacological Treatment in Alzheimer's Disease and Associated Disorders

NCT ID: NCT01143350

Last Updated: 2011-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-03-31

Brief Summary

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The STIM-EHPAD study (for stimulation in nursing home) aims to evaluate the short and medium term effectiveness of staff education as a non-pharmacological intervention to manage apathy in older people with a diagnosis of dementia.

* Primary efficacy criteria: Apathy Inventory clinician score changes
* Secondary efficacy criteria: Apathy Inventory patient and caregiver version changes, Observation scale changes, frequency and severity of the other BPSD using the NPI, qualitative analysis of the nursing home staff behavioural changes

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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EHPAD Training and Stimulation

EHPAD of the group of Training / Stimulation will benefit:

* after a training in behaviours to be held or in methods of stimulation aiming at the reduction of disturbances of behaviour at type of apathy. This information will be transmitted in l 'ensemble of l 'équipe of l 'EHPAD by a training officer.
* of a structuring of the activities of animation offered to the inhabitants, This information will be regrouped in chips worked out like TNM - EHPAD.

Group Type EXPERIMENTAL

Bras A (EHPAD Training and stimulation)

Intervention Type OTHER

EHPAD of the group of Training / Stimulation will benefit:

* after a training in behaviours to be held or in methods of stimulation aiming at the reduction of disturbances of behaviour at type of apathy. This information will be transmitted in l 'ensemble of l 'équipe of l 'EHPAD by a training officer.
* of a structuring of the activities of animation offered to the inhabitants, This information will be regrouped in chips worked out like TNM - EHPAD.

2- EHPAD control

EHPAD of the reference group, will have their habitual functioning

Group Type PLACEBO_COMPARATOR

EHPAD Control

Intervention Type OTHER

EHPAD of the reference group, will have their habitual functioning

Interventions

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Bras A (EHPAD Training and stimulation)

EHPAD of the group of Training / Stimulation will benefit:

* after a training in behaviours to be held or in methods of stimulation aiming at the reduction of disturbances of behaviour at type of apathy. This information will be transmitted in l 'ensemble of l 'équipe of l 'EHPAD by a training officer.
* of a structuring of the activities of animation offered to the inhabitants, This information will be regrouped in chips worked out like TNM - EHPAD.

Intervention Type OTHER

EHPAD Control

EHPAD of the reference group, will have their habitual functioning

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients older than 65 years
* A diagnosis of dementia according to the ICD 10 criteria
* MMSE score ≤ 24
* Presenting the diagnostic criteria of apathy (cf page ??)
* An Apathy Inventory clinician total score \>3 (with at least a score higher than 1 at one of the 3 dimensions; lack of initiative, lack of interest, emotional blunting)

Exclusion Criteria

* Patients more than 65 years
* MMSE score \> 24
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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DRCI du CHU de Nice

Principal Investigators

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Philippe Ph ROBERT, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Robert

Nice, Alpes-Maritimes, France

Site Status

Countries

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France

Other Identifiers

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09-PP-09

Identifier Type: -

Identifier Source: org_study_id

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