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

NCT02288221 | Terminated

• 1 other identifier: 14-PP-04
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Deterioration

Outcome Measures

Primary Outcomes (1)

• Time spent by the patient using the non-therapeutic solutions

  6 months

Study Arms (2)

With non pharmacological therapeutic

EXPERIMENTAL

Installation of ICT at patient's home

Other: Patient's answer with non pharmacological therapeutic

Without non pharmacological therapeutic

ACTIVE COMPARATOR

No change at patient's home

Other: Patient's answer without non pharmacological therapeutic

Interventions

Patient's answer with non pharmacological therapeutic OTHER

Installation at patient's home of : * aromatherapy * music therapy * cognitive training in multimedia application offering cognitive games

With non pharmacological therapeutic

Patient's answer without non pharmacological therapeutic OTHER

No installation at patient's home

Without non pharmacological therapeutic

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Institut Claude Pompidou

Nice, 06000, France

Location

Study Officials

• Renaud DAVID, Dr

  Centre Hospitalier Universitaire de Nice

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2014
• First Posted: November 11, 2014
• Study Start: June 4, 2015
• Primary Completion: July 5, 2017
• Study Completion: July 5, 2017
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

FR (1)