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

November 25, 2025 updated by: Centre Hospitalier Universitaire de Nice

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nice, France, 06000
        • Institut Claude Pompidou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: With non pharmacological therapeutic
Installation of ICT at patient's home
Other: Patient's answer with non pharmacological therapeutic

Installation at patient's home of :

  • aromatherapy
  • music therapy
  • cognitive training in multimedia application offering cognitive games
Active Comparator: Without non pharmacological therapeutic
No change at patient's home
Other: Patient's answer without non pharmacological therapeutic
No installation at patient's home

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Study Director: Renaud DAVID, Dr, Centre Hospitalier Universitaire De Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 4, 2015

Primary Completion (Actual)

July 5, 2017

Study Completion (Actual)

July 5, 2017

Study Registration Dates

First Submitted

August 19, 2014

First Submitted That Met QC Criteria

November 7, 2014

First Posted (Estimated)

November 11, 2014

Study Record Updates

Last Update Posted (Estimated)

December 2, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 14-PP-04

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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