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

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02838563
Acronym
SIWA
Enrollment
135
Registered
2016-07-20
Start date
2016-01-13
Completion date
2017-04-27
Last updated
2017-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Well-Being

Keywords

Dementia, Alzheimer, Well-Being

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.

Interventions

OTHERSIWA

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).

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation between SIWA and an other quality of life scale (Qol-AD)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

MeasureTime frameDescription
Stability over time of SIWAThe 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)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)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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026