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

Not Applicable

Completed

• Conditions: Cognitive Deterioration
• Interventions: Other: Patient's answer without non pharmacological therapeutic; Other: Patient's answer with non pharmacological therapeutic

• Registration Number: NCT02288221
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-08-19
• Study First Submitted QC: 2014-11-07
• Study First Posted: 2014-11-11
• Study Start: 2015-06-04
• Primary Completion: 2017-07-05
• Study Completion: 2017-07-05
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Without non pharmacological therapeutic	Patient's answer without non pharmacological therapeutic	No change at patient's home
With non pharmacological therapeutic	Patient's answer with non pharmacological therapeutic	Installation of ICT at patient's home

Primary Outcome Measures

Name	Time	Method
Time spent by the patient using the non-therapeutic solutions	6 months

Trial Locations

Locations (1)

Institut Claude Pompidou; 🇫🇷 Nice, France