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

Cognitive Deterioration Clinical Trial

— SafEE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02288221
• Other study ID #: 14-PP-04
• Status: Completed
• Phase: N/A
• Start date: June 4, 2015
• Est. completion date: July 5, 2017

Study information

• Verified date: November 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: July 5, 2017
• Est. primary completion date: July 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Deterioration

Intervention

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
• Patient's answer without non pharmacological therapeutic
No installation at patient's home

Locations

Country	Name	City	State
France	Institut Claude Pompidou	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time spent by the patient using the non-therapeutic solutions		6 months