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

NCT ID: NCT02288221

Last Updated: 2025-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-04

Study Completion Date

2017-07-05

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.

Conditions

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Cognitive Deterioration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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With non pharmacological therapeutic

Installation of ICT at patient's home

Group Type EXPERIMENTAL

Patient's answer with non pharmacological therapeutic

Intervention Type OTHER

Installation at patient's home of :

* aromatherapy
* music therapy
* cognitive training in multimedia application offering cognitive games

Without non pharmacological therapeutic

No change at patient's home

Group Type ACTIVE_COMPARATOR

Patient's answer without non pharmacological therapeutic

Intervention Type OTHER

No installation at patient's home

Interventions

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Patient's answer with non pharmacological therapeutic

Installation at patient's home of :

* aromatherapy
* music therapy
* cognitive training in multimedia application offering cognitive games

Intervention Type OTHER

Patient's answer without non pharmacological therapeutic

No installation at patient's home

Intervention Type OTHER

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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Renaud DAVID, Dr

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire de Nice

Locations

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Institut Claude Pompidou

Nice, , France

Site Status

Countries

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France

Other Identifiers

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14-PP-04

Identifier Type: -

Identifier Source: org_study_id

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