Non Pharmacological Treatment in Alzheimer's Disease and Associated Disorders

Centre Hospitalier Universitaire de Nice

Status: Terminated

Conditions: Alzheimer's Disease

Treatments: Other: EHPAD Control; Other: Bras A (EHPAD Training and stimulation)

Study type: Interventional

Funder types: Other

Identifiers

NCT01143350

09-PP-09

Details and patient eligibility

About

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

Enrollment: 300 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups, including a placebo group

EHPAD Training and Stimulation

Experimental group

Description:

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.

Treatment:

Other: Bras A (EHPAD Training and stimulation)

2- EHPAD control

Placebo Comparator group

Description:

EHPAD of the reference group, will have their habitual functioning

Treatment:

Other: EHPAD Control