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

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Well-Being

Intervention / Treatment
-----------------
* Other: SIWA


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient living in nursing home<br>Patient with an Alzheimer Disease or related disorder living in nursing home. | Other: SIWA<br>* 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between SIWA and an other quality of life scale (Qol-AD) | 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. | the Qol-AD is collected once. (Day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stability over time of SIWA | 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. | The SIWA is collected twice at ten minute intervals (Day 1) | 
| Correlation between SIWA and an health scale (EQ-5D) | 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). | the EQ-5D is collected once. (Day 1) | 
| Correlation between SIWA and behavioral and psychological symptom of dementia (BPSD) (NPI) | 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. | the NPI is collected once. (Day 1) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dementia, Alzheimer, Well-Being