Safe & Easy Environment at Home for Patients Presenting a Frail Syndrome

Study Overview
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Brief Summary
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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 SafEE project develop non pharmacological therapeutic through diferent ICT (stimulation aromatherapy automatic fragrance, training interface based on Kinect sensor...) . The goal of this study is to validate the acceptability, sensitivity and efficacy of the systems.

Detailed Description
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The non pharmacological therapeutic will be install at patient's home : aromatherapy, music therapy, cognitive training in multimedia application offering cognitive games. Also smart phone will be given to the patient : to help him move with a geolocation application, to remind him of his daily needs (shopping lists, people to call, etc ...) with an alert apllication.

Official Title
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SafEE : Safe & Easy Environment at Home for Patients Presenting a Frail Syndrome

Conditions
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Cognitive Deterioration

Intervention / Treatment
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* Other: Patient's answer with non pharmacological therapeutic
* Other: Patient's answer without non pharmacological therapeutic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female age ≥ 60 years with memory complaint Score at the Mini Mental Test (MMSE) ≥ 26. Score at the Clinical Dementia Rating Scale (CDR) ≤ 0.5. Exclusion Criteria: Sensory defect (visual or olfactory) preventing the patient to perfectly meet therapeutic solutions. Prescription new psychotropic medication (hypnotic, anxiolytic, antidepressant, antipsychotic) in the week preceding the assessment. Subject epileptic. Subject vulnerable

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: With non pharmacological therapeutic<br>Installation of ICT at patient's home | Other: Patient's answer with non pharmacological therapeutic<br>* Installation at patient's home of : aromatherapy music therapy cognitive training in multimedia application offering cognitive games<br>|
| Active Comparator: Without non pharmacological therapeutic<br>No change at patient's home | Other: Patient's answer without non pharmacological therapeutic<br>* No installation at patient's home<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time spent by the patient using the non-therapeutic solutions |  | 6 months |