Clinical trial NCT01314131: Use of Autobiographical and Interest Assessment for a Better Stimulation of Patients in Nursing Home
Official title: Use of Autobiographical and Interest Assessment for a Better Stimulation of Patients in Nursing Home
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer's Disease
Lead sponsor: Association Recherche Méthodologie Evaluation Psychiatrique
Sponsor class: OTHER
First posted: 2011-03-14
Enrollment: 48
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose is to evaluate patients' interests (patients in nursing home). Moreover the study aims to evaluate whether an activity for which the patient is interested in, allows a better involvement and stimulation.

Detailed description: Context :

Behavioral and Psychological Symptoms of Dementia (BPSD) arouse researchers' interest because they are frequent manifestations responsible for a large share of the suffering of patients and caregivers. Apathy is the most frequent of them.

Systematic literature reviews on non-pharmacological treatment for BPSD indicates that some technique and more particularly residential care staff training program appear to have promising results, even if the level of evidence of efficacy remains moderate partly because of the paucity of scientific quality research in this area.

The most of them comes from Anglo-Saxon country. In France, the TNM en EHPAD study demonstrated the staff training program efficacy regarding to the management of behavioral positive symptoms such as agitation or aggressiveness compared to a control group

Aims of the study :

The aims of the study is to evaluate the short and medium term effectiveness of staff training program to manage and stimulate patients with a diagnosis of Alzheimer's disease or associated disorders and presenting BPSD of the apathy type and living in nursing homes.

Description :

A Randomized controlled trial (randomization by nursing home) presents as a routine clinical procedure according to the French regulation. Raters and our statistician are unaware and blind to the randomization. The trial takes place in 4 nursing homes.

To be included, patients are older than 65 years with a diagnosis of Alzheimer's disease or associated disorder and present the diagnostic criteria of apathy, within a moderate to severe stage of the disease.

Data are collected at baseline, month 1 and at month 4, namely 3 months after the end of the training programme thanks to the Apathy Inventory Clinician version (AI-C), the Neuropsychiatric Inventory for the staff members (NPI-ES), the AD QOL, an Observation Scale and a qualitative analysis of the official caregiver's knowledge and perception about BPSD especially apathy and their expectations concerning the training program.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Alzheimer's disease
* MMSE score between 12 and 24
* Patient involved in organized activities in nursing home

Exclusion Criteria:

Patients:

* Who are not able to understand and answer to questions for the study
* \< 60 years of age
* Who are not able to sit
* Aphasic

Primary outcomes:
measure: The primary outcome is the engagement duration for an activity, measured by the OME (Observational Measurement of Engagement) scale.
timeFrame: 10 times during two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Centre Mémoire de Ressources et de Recherche
Study officials:
affiliation: Centre Mémoire de Ressources et de Recherche
name: Philippe ROBERT, PhD
role: PRINCIPAL_INVESTIGATOR
References: