- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02518243
Safe & Easy for Alzheimer's Disease and Related Pathologies (SaFEE2)
All over the world the increasing prevalence of chronic disorders and its impact on functional decline is challenging the sustainability of health care systems. Older individuals also frequently experience the reversible "frailty syndrome", which overlaps with chronic diseases, increasing incidence of disability.
Building a global system aiming to take in charge all causes leading to loss of autonomy is a rather complicated task involving numerous Information and Communication technologies (ICT) solutions which are not always easy to use in everyday life.
The SafEE (Safe Easy Environment) project aim is to improve the safety, autonomy and quality of life of older people at risk.
The SafEE2 project develop non pharmacological therapeutic through diferent ICT (stimulation aromatherapy automatic fragrance ...) .
The goal of this study is to validate the acceptability, sensitivity and efficacy of the systems.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The non pharmacological therapeutic will be install at hospital room :
- aromatherapy,
- music therapy,
- cognitive training in multimedia application offering cognitive games.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Nice, France, 06100
- Ehpad Valrose
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Subjects with a diagnosis of Alzheimer's disease according to NINCDS-ADRDA (McKhann, Drachman et al. 1984) or typical or atypical Alzheimer's disease (Dubois B. et al. 2007).
- Score at Mini Mental Test (MMSE) ≥16.
- Subjects residing in nursing homes.
- Subjects beneficiaries of a social security scheme.
- Signature of free and informed consent.
Exclusion Criteria:
- Failure to pass the neuropsychological tests because of a sensory or motor deficit.
- Sensory deficit (olfactory or visual) preventing the patient made perfectly meet the therapeutic solutions.
- Prescription of a new treatment psychotropic (hypnotic, anxiolytic, antidepressant, antipsychotic) in the week before the evaluation;
- Persons deprived of liberty (administrative or judicial).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Alzheimer's Disease
|
Installation at patient's home of :
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tolerance of the systems set up and use frequency evaluated using the Caregiver Questionnaire
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Investigators
- Study Director: Renaud DAVID, MD, Centre Hospitalier Universitaire de Nice
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 14-PP-08
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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