NCT02838563

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2017

Completed
Last Updated

July 13, 2017

Status Verified

February 1, 2017

Enrollment Period

1.3 years

First QC Date

July 18, 2016

Last Update Submit

July 11, 2017

Conditions

Well-Being

Keywords

DementiaAlzheimerWell-Being

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Stability over time of SIWA

    The SIWA is collected twice at ten minute intervals (Day 1)

  • Correlation between SIWA and an health scale (EQ-5D)

    the EQ-5D is collected once. (Day 1)

  • Correlation between SIWA and behavioral and psychological symptom of dementia (BPSD) (NPI)

    the NPI is collected once. (Day 1)

Study Arms (1)

Patient living in nursing home

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

Other: SIWA

Interventions

SIWAOTHER

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).

Patient living in nursing home

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Villeurbanne, 69100, France

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Pierre Krolak-Salmon, Pr

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2016

First Posted

July 20, 2016

Study Start

January 13, 2016

Primary Completion

April 27, 2017

Study Completion

April 27, 2017

Last Updated

July 13, 2017

Record last verified: 2017-02

Locations

FR(1)