Cognitive Deterioration Clinical Trial
— SafEEOfficial title:
SafEE : Safe & Easy Environment at Home for Patients Presenting a Frail Syndrome
NCT number | NCT02288221 |
Other study ID # | 14-PP-04 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 4, 2015 |
Est. completion date | July 5, 2017 |
Verified date | November 2023 |
Source | Centre Hospitalier Universitaire de Nice |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | Institut Claude Pompidou | Nice |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nice |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time spent by the patient using the non-therapeutic solutions | 6 months |
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