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

Well-Being Clinical Trial

— SIWA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02838563
• Other study ID #: 69HCL16_0441
• Status: Terminated
• Phase: N/A
• First received: July 18, 2016
• Last updated: July 11, 2017
• Start date: January 13, 2016
• Est. completion date: April 27, 2017

Study information

• Verified date: February 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 135
• Est. completion date: April 27, 2017
• Est. primary completion date: April 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Well-Being

Intervention

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).

Locations

Country	Name	City	State
France	Centre de Recherche Clinique " Vieillissement-Cerveau-Fragilité ", Hôpital des Charpennes, Hospices Civils de Lyon	Villeurbanne

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)