Trial record 11 of 45 for:    Open Studies | "Nursing Homes"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Association Recherche Méthodologie Evaluation Psychiatrique.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Association Recherche Méthodologie Evaluation Psychiatrique
ClinicalTrials.gov Identifier:
NCT01314131
First received: March 11, 2011
Last updated: April 28, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention
Alzheimer's Disease
Behavioral: Stimulation group

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Use of Autobiographical and Interest Assessment for a Better Stimulation of Patients in Nursing Home

Resource links provided by NLM:


Further study details as provided by Association Recherche Méthodologie Evaluation Psychiatrique:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

    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)



Estimated Enrollment: 48
Study Start Date: March 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01314131

Contacts
Contact: Philippe ROBERT, PhD +33492034770 robert.ph@chu-nice.fr

Locations
France
Centre Mémoire de Ressources et de Recherche Recruiting
Nice, France, 06000
Contact: Philippe ROBERT, PhD    +33492034770    robert.ph@chu-nice.fr   
Principal Investigator: Philippe ROBERT, PhD         
Sponsors and Collaborators
Association Recherche Méthodologie Evaluation Psychiatrique
Investigators
Principal Investigator: Philippe ROBERT, PhD Centre Mémoire de Ressources et de Recherche
  More Information

No publications provided

Responsible Party: Pr ROBERT Philippe, Centre Mémoire de Ressources et de Recherche
ClinicalTrials.gov Identifier: NCT01314131     History of Changes
Other Study ID Numbers: ARMEP-01
Study First Received: March 11, 2011
Last Updated: April 28, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014