Use of Autobiographical and Interest Assessment for a Better Stimulation of Patients in Nursing Home

Alzheimer's Disease Clinical Trial

Official title:

Use of Autobiographical and Interest Assessment for a Better Stimulation of Patients in Nursing Home

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01314131
• Other study ID #: ARMEP-01
• Status: Recruiting
• Phase: N/A
• First received: March 11, 2011
• Last updated: April 28, 2011
• Start date: March 2011
• Est. completion date: June 2012

Study information

• Verified date: January 2011
• Source: Association Recherche Méthodologie Evaluation Psychiatrique
• Contact: Philippe ROBERT, PhD
• Phone: +33492034770
• Email: robert.ph[@]chu-nice.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: June 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Behavioral:
• Stimulation group
Patients living in nursing home can be enrolled in the study by giving their verbal consent. The trial lasts two weeks for each patients and it will be performed in three parts : a cognitive and behaviour assessment : MMSE, BREF, NPI, IA an interest questionnaire for patients. It contains 40 questions about activities. the intervention : patients will be propose 5 activities. 4 of them are activities that patients are interested in. Each activity have to last 15 minutes and the stimulation is measured by a scale named "Observational Measurement of Engagement ".

Locations

Country	Name	City	State
France	Centre Mémoire de Ressources et de Recherche	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Association Recherche Méthodologie Evaluation Psychiatrique

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is the engagement duration for an activity, measured by the OME (Observational Measurement of Engagement) scale.	First, a cognitive and behaviour assessment (specially autobiographical memory) is performed to patients.; Then, the patient is proposed to do 5 activities. 4 of them correpond to activities for which he is interested in (depending on the assessment results). The therapist assesses if the patient is stimulated, by measuring the time for which he is involved in doing the activity (with OME Scale)	10 times during two weeks	Yes