Safe & Easy for Alzheimer's Disease and Related Pathologies

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.

Completed

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Key information

Conditions

Cognitive Deterioration

Age range

60 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ehpad Valrose

Nice, 06100, France

About this study

The non pharmacological therapeutic will be install at hospital room :

aromatherapy,
music therapy,
cognitive training in multimedia application offering cognitive games.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Primary outcomes

Tolerance of the systems set up and use frequency evaluated using the Caregiver Questionnaire

Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: SaFEE2

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Aug 7, 2015
Registry last updated: Nov 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed