Use of Autobiographical and Interest Assessment for a Better Stimulation of Patients in Nursing Home
Recruitment status was: Recruiting
|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|
- 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)
|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)|
|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 :
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01314131
|Centre Mémoire de Ressources et de Recherche|
|Nice, France, 06000|
|Principal Investigator:||Philippe ROBERT, PhD||Centre Mémoire de Ressources et de Recherche|