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

NCT ID: NCT02838563

Last Updated: 2017-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

135 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-13

Study Completion Date

2017-04-27

Brief Summary

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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.

Detailed Description

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Conditions

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Well-Being

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient living in nursing home

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

SIWA

Intervention Type OTHER

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).

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre Krolak-Salmon, Pr

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Centre de Recherche Clinique " Vieillissement-Cerveau-Fragilité ", Hôpital des Charpennes, Hospices Civils de Lyon

Villeurbanne, , France

Site Status

Countries

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France

Other Identifiers

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69HCL16_0441

Identifier Type: -

Identifier Source: org_study_id

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