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

Centre Hospitalier Universitaire de Nice

Status: Terminated

Conditions: Cognitive Deterioration

Treatments: Other: Patient's answer with non pharmacological therapeutic; Other: Patient's answer without non pharmacological therapeutic

Study type: Interventional

Funder types: Other

Identifiers

NCT02288221

14-PP-04

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 4 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

With non pharmacological therapeutic

Experimental group

Description:

Installation of ICT at patient's home

Treatment:

Other: Patient's answer with non pharmacological therapeutic

Without non pharmacological therapeutic

Active Comparator group

Description:

No change at patient's home

Treatment:

Other: Patient's answer without non pharmacological therapeutic