Safe & Easy for Alzheimer's Disease and Related Pathologies

NCT02518243 | Completed

• 1 other identifier: 14-PP-08
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Deterioration

Outcome Measures

Primary Outcomes (1)

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

  3 months

Study Arms (1)

Alzheimer's Disease

EXPERIMENTAL

Other: Patient's answer with non pharmacological therapeutic

Interventions

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

Alzheimer's Disease

Eligibility Criteria

• Age: 60 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Ehpad Valrose

Nice, 06100, France

Location

Study Officials

• Renaud DAVID, MD

  Centre Hospitalier Universitaire de Nice

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2015
• First Posted: August 7, 2015
• Study Start: June 1, 2015
• Primary Completion: March 22, 2017
• Study Completion: March 22, 2017
• Last Updated: November 14, 2023

Record last verified: 2023-11

Locations

FR (1)