Non Pharmacological Treatment in Alzheimer's Disease and Associated Disorders

Not Applicable

Terminated

• Conditions: Alzheimer's Disease
• Interventions: Other: Bras A (EHPAD Training and stimulation); Other: EHPAD Control

• Registration Number: NCT01143350
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2010-02-25
• Status Verified: 2010-03
• Study Start: 2010-03
• Primary Completion: 2010-03
• Study First Submitted QC: 2010-06-11
• Study First Posted: 2010-06-14
• Study Completion: 2011-03
• Last Update Submitted: 2011-05-31
• Last Update Posted: 2011-06-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EHPAD Training and Stimulation	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.
2- EHPAD control	EHPAD Control	EHPAD of the reference group, will have their habitual functioning

Primary Outcome Measures

Name	Time	Method
Identification of yet unknown enzymes involved in the processing of Ab, especially on those responsible for the exoproteasic truncation of Ab at its N-terminus.	1 year	Identification of yet unknown enzymes involved in the processing of Ab, especially on those responsible for the exoproteasic truncation of Ab at its N-terminus.

Secondary Outcome Measures

Name	Time	Method
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	1 year

Trial Locations

Locations (1)

Robert; 🇫🇷 Nice, Alpes-Maritimes, France