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

April 28, 2011 updated by: Association Recherche Méthodologie Evaluation Psychiatrique
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Nice, France, 06000
        • Recruiting
        • Centre Mémoire de Ressources et de Recherche
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
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 ".
Other Names:
  • interest
  • autobiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary outcome is the engagement duration for an activity, measured by the OME (Observational Measurement of Engagement) scale.
Time Frame: 10 times during two weeks

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association Recherche Méthodologie Evaluation Psychiatrique

Investigators

  • Principal Investigator: Philippe ROBERT, PhD, Centre Mémoire de Ressources et de Recherche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

September 1, 2011

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

March 11, 2011

First Submitted That Met QC Criteria

March 11, 2011

First Posted (Estimate)

March 14, 2011

Study Record Updates

Last Update Posted (Estimate)

April 29, 2011

Last Update Submitted That Met QC Criteria

April 28, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARMEP-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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