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Safe & Easy for Alzheimer's Disease and Related Pathologies

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02518243
Acronym
SaFEE2
Enrollment
7
Registered
2015-08-07
Start date
2015-06-30
Completion date
2017-03-22
Last updated
2023-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Deterioration

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 SafEE2 project develop non pharmacological therapeutic through diferent ICT (stimulation aromatherapy automatic fragrance ...) . The goal of this study is to validate the acceptability, sensitivity and efficacy of the systems.

Detailed description

The non pharmacological therapeutic will be install at hospital room : * aromatherapy, * music therapy, * cognitive training in multimedia application offering cognitive games.

Interventions

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

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Subjects with a diagnosis of Alzheimer's disease according to NINCDS-ADRDA (McKhann, Drachman et al. 1984) or typical or atypical Alzheimer's disease (Dubois B. et al. 2007). * Score at Mini Mental Test (MMSE) ≥16. * Subjects residing in nursing homes. * Subjects beneficiaries of a social security scheme. * Signature of free and informed consent.

Exclusion criteria

* Failure to pass the neuropsychological tests because of a sensory or motor deficit. * Sensory deficit (olfactory or visual) preventing the patient made perfectly meet the therapeutic solutions. * Prescription of a new treatment psychotropic (hypnotic, anxiolytic, antidepressant, antipsychotic) in the week before the evaluation; * Persons deprived of liberty (administrative or judicial).

Design outcomes

Primary

MeasureTime frame
Tolerance of the systems set up and use frequency evaluated using the Caregiver Questionnaire3 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026