Safe & Easy for Alzheimer's Disease and Related Pathologies (SaFEE2)

November 13, 2023 updated by: Centre Hospitalier Universitaire de Nice

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The non pharmacological therapeutic will be install at hospital room :

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

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nice, France, 06100
        • Ehpad Valrose

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alzheimer's Disease
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tolerance of the systems set up and use frequency evaluated using the Caregiver Questionnaire
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Study Director: Renaud DAVID, MD, Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

March 22, 2017

Study Completion (Actual)

March 22, 2017

Study Registration Dates

First Submitted

July 7, 2015

First Submitted That Met QC Criteria

August 5, 2015

First Posted (Estimated)

August 7, 2015

Study Record Updates

Last Update Posted (Estimated)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 13, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 14-PP-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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