Non Pharmacological Treatment in Alzheimer's Disease and Associated Disorders
1 other identifier
interventional
300
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2010
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedFirst Posted
Study publicly available on registry
June 14, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedJune 1, 2011
March 1, 2010
Same day
February 25, 2010
May 31, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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.
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 Outcomes (1)
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
1 year
Study Arms (2)
EHPAD Training and Stimulation
EXPERIMENTALEHPAD 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.
2- EHPAD control
PLACEBO COMPARATOREHPAD of the reference group, will have their habitual functioning
Interventions
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.
EHPAD of the reference group, will have their habitual functioning
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Patients more than 65 years
- MMSE score \> 24
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Robert
Nice, Alpes-Maritimes, 06001, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philippe Ph ROBERT, PhD
CHU de Nice - CM2R - Hôpital de Cimiez - 4 avenue reine victoria - 06 003 Nice cedex 1
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 25, 2010
First Posted
June 14, 2010
Study Start
March 1, 2010
Primary Completion
March 1, 2010
Study Completion
March 1, 2011
Last Updated
June 1, 2011
Record last verified: 2010-03