Validation of a Scale of Well-Being Assessment (SIWA) in Patients With Alzheimer’s Disease or a Related Disease.

Overview

Current scales are not suited to a direct measure for the elderly with cognitive disorders and are difficult to handle for the care teams. In this context, a visual analog scale was created to answer a single question "How are you feeling now, immediately?" with the help of pictograms. This study aims to assess the validity and reliability of the Scale of Well-Being Assessment (SIWA) (in french : Echelle d'Evaluation Instantanée du Bien-Etre (EVIBE)) in people with Alzheimer's disease or a related disease.

Full Title of Study: “Validation of a Scale of Well-Being Assessment (SIWA) in Patients With Alzheimer’s Disease or a Related Disease.”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 27, 2017

Interventions

  • Other: SIWA
    • To investigate the scale reliability over time, SIWA are assessed twice, ten minutes apart. To investigate the validity of the tool, SIWA is correlated with another quality of life questionnaire (QoL-AD), a quality of health scale including an analog portion (EQ 5D), and a behavioral disorder scale (Neuropsychiatric Inventory, NPI).

Arms, Groups and Cohorts

  • Patient living in nursing home
    • Patient with an Alzheimer Disease or related disorder living in nursing home.

Clinical Trial Outcome Measures

Primary Measures

  • Correlation between SIWA and an other quality of life scale (Qol-AD)
    • Time Frame: the Qol-AD is collected once. (Day 1)
    • In the Qol-Ad, the patient assesses the quality of life (bad / average / good / excellent) on five areas: relationships with friends and family, concerns about finances, physical condition, mood, and an overall assessment of life quality through 13 questions.

Secondary Measures

  • Stability over time of SIWA
    • Time Frame: The SIWA is collected twice at ten minute intervals (Day 1)
    • The SIWA is a visual analogue scale for reporting the status of the patient’s well-being at a specific time. On a graduated scale from 0 to 5, the caregiver should position a cursor : position from the left corresponding to the lowest feeling of well, position from the right corresponding to the highest feeling of well-being.
  • Correlation between SIWA and an health scale (EQ-5D)
    • Time Frame: the EQ-5D is collected once. (Day 1)
    • In the EQ 5D, the patient evaluates his state of health on 5 dimensions: mobility, human autonomy, common activities, pain / discomfort and anxiety / depression based on 3 levels “no problems”, “some problems” and “severe problems”. Then the patient is asked to distinguish his general state of health on an analog scale from 0 (worst imaginable health state) to 100 (best imaginable health state).
  • Correlation between SIWA and behavioral and psychological symptom of dementia (BPSD) (NPI)
    • Time Frame: the NPI is collected once. (Day 1)
    • Each of the 12 BPSD (delusions, hallucinations, agitation, depression, anxiety, excitement, apathy, disinhibition, depression, aberrant motor behavior, sleep and appetite) is evaluated from 0 to 12, depending on its frequency and severity.

Participating in This Clinical Trial

Inclusion Criteria

  • Enrolled patients must have given themselves, or through a trusted person referred to the Article L. 1111-6 of the Code of Public Health, failing thereof, by the family, or, a person maintaining close and stable ties. For adults under guardianship, permission must be given by the legal representative of the person. The research will benefit from the backing of persons Protection Committee (PPC) prior to its implementation. – Patient living in one of the nursing home or hospital services in the project; – Patient with Alzheimer's or a related disease Exclusion Criteria:

  • severe, progressive or unstable pathology, which may interfere with the evaluation variables; – deafness or blindness may compromise patient assessment

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospices Civils de Lyon
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pierre Krolak-Salmon, Pr, Principal Investigator, Hospices Civils de Lyon

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.