Non Pharmacological Treatment in Alzheimer's Disease and Associated Disorders

May 31, 2011 updated by: Centre Hospitalier Universitaire de Nice

The STIM-EHPAD study (for stimulation in nursing home) aims to evaluate the short and medium term effectiveness of staff education as a non-pharmacological intervention to manage apathy in older people with a diagnosis of dementia.

  • Primary efficacy criteria: Apathy Inventory clinician score changes
  • Secondary efficacy criteria: Apathy Inventory patient and caregiver version changes, Observation scale changes, frequency and severity of the other BPSD using the NPI, qualitative analysis of the nursing home staff behavioural changes

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

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 Locations

  • France
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06001
        • Robert

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients older than 65 years
  • A diagnosis of dementia according to the ICD 10 criteria
  • MMSE score ≤ 24
  • Presenting the diagnostic criteria of apathy (cf page ??)
  • An Apathy Inventory clinician total score >3 (with at least a score higher than 1 at one of the 3 dimensions; lack of initiative, lack of interest, emotional blunting)

Exclusion Criteria:

  • Patients more than 65 years
  • MMSE score > 24

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

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EHPAD Training and Stimulation

EHPAD of the group of Training / Stimulation will benefit:

  • after a training in behaviours to be held or in methods of stimulation aiming at the reduction of disturbances of behaviour at type of apathy. This information will be transmitted in l 'ensemble of l 'équipe of l 'EHPAD by a training officer.
  • of a structuring of the activities of animation offered to the inhabitants, This information will be regrouped in chips worked out like TNM - EHPAD.
Other: Bras A (EHPAD Training and stimulation)

EHPAD of the group of Training / Stimulation will benefit:

  • after a training in behaviours to be held or in methods of stimulation aiming at the reduction of disturbances of behaviour at type of apathy. This information will be transmitted in l 'ensemble of l 'équipe of l 'EHPAD by a training officer.
  • of a structuring of the activities of animation offered to the inhabitants, This information will be regrouped in chips worked out like TNM - EHPAD.
Placebo Comparator: 2- EHPAD control
EHPAD of the reference group, will have their habitual functioning
Other: EHPAD Control
EHPAD of the reference group, will have their habitual functioning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of yet unknown enzymes involved in the processing of Ab, especially on those responsible for the exoproteasic truncation of Ab at its N-terminus.
Time Frame: 1 year
Identification of yet unknown enzymes involved in the processing of Ab, especially on those responsible for the exoproteasic truncation of Ab at its N-terminus.
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary efficacy criteria: Apathy Inventory patient and caregiver version changes, Observation scale changes, frequency and severity of the other BPSD using the NPI, qualitative analysis of the nursing home staff behavioural changes
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: Philippe Ph ROBERT, PhD, CHU de Nice - CM2R - Hôpital de Cimiez - 4 avenue reine victoria - 06 003 Nice cedex 1

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, 2010

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

February 25, 2010

First Submitted That Met QC Criteria

June 11, 2010

First Posted (Estimate)

June 14, 2010

Study Record Updates

Last Update Posted (Estimate)

June 1, 2011

Last Update Submitted That Met QC Criteria

May 31, 2011

Last Verified

March 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-PP-09

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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