Psychometric Validation of the "Antillanisée" Version of the Mini Mental State Examination (MMSEa) (MMENSEA)
Primary Purpose
Elderly Patients, Cognitive Disorder, Alzheimer Disease
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
"Antillanisée" Mini Mental State Examination (MMSEa)
Sponsored by
About this trial
This is an interventional other trial for Elderly Patients focused on measuring Cognitive disorders, Alzheimer's disease, Mini Mental State Examination, Geriatry
Eligibility Criteria
Inclusion Criteria:
- Subject of 65 years old and over
- Subject admitted in a geriatric day hospital
- Patients of creole culture
- Subject having French and/or Creole as mother tongue
- Subject able to undergo neuropsychological tests
- Subject having given informed consent or, informed consent given by his or her primary caregiver
- Subject affiliated to a social security scheme
Exclusion Criteria:
- Subject with a disability seriously compromising oral communication (understanding and expression)
- Subject with behavioral disorder that does not allow for testing
- Subject in general condition not allowing its participation in the tests
- Subject involved in another study including an exclusion period still in progress at the time of inclusion
Sites / Locations
- CHU de Martinique
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Elderly patient (65 and more)
Arm Description
Ederly patients seen in geriatric day hospital, from creole culture.
Outcomes
Primary Outcome Measures
Evaluation of the psychometric properties of the questionnaire MMSEa
The following will be measured:
feasibility and acceptability;
validity of structure;
discriminant validity;
predictive validity;
validity of convergence;
reliability (internal consistency,reproducibility (test-retest)).
Secondary Outcome Measures
Evaluation of the psychometric properties of questionnaire SPPB
The following will be measured:
feasibility and acceptability;
validity of structure;
discriminant validity;
predictive validity;
reliability (internal consistency,reproducibility (test-retest)).
Full Information
NCT ID
NCT03324711
First Posted
January 11, 2017
Last Updated
February 22, 2022
Sponsor
University Hospital Center of Martinique
1. Study Identification
Unique Protocol Identification Number
NCT03324711
Brief Title
Psychometric Validation of the "Antillanisée" Version of the Mini Mental State Examination (MMSEa)
Acronym
MMENSEA
Official Title
Psychometric Validation of the "Antillanisée" Version of the Mini Mental State Examination
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
Departure of the Principal Investigator
Study Start Date
November 15, 2016 (Actual)
Primary Completion Date
April 11, 2019 (Actual)
Study Completion Date
July 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Center of Martinique
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main objective of the study is to analyze the psychometric properties of the "antillanisée" version of the Mini Mental State Examination (MMSEa).
The methodology used will permit to explore the feasibility, acceptability, validity and reliability of the tool.
The psychometric validation of a version adapted transculturally will increase the value of the results obtained with this test and will make it possible to refine the screening of existing cognitive disorders for elderly subjects with Alzheiner's disease or related disorders.
Detailed Description
Patients will be recruited at the Geriatric Day Hospital.
These patients came to a geriatric day hospital for examination without restriction on the reason for the hospitalization.
They are referred by their general practitionner or referred by a specialist physician, live at home or in an institution and are representative of the geriatric population addressed by the MMSEa.
The main objective of the study is to analyze the psychometric properties of the "antillanisée" version of the Mini Mental State Examination (MMSEa).
The ancillary objective of this study will be to carry out the psychometric validation of the Short Physical Performance Battery (SPPB) in people aged 65 years or older.
It is an instrument for measuring the physical performance of subjects whose transcultural adaptation and psychometric validation have already been performed in subjects aged 65 to 74 years.
SPPB is used routinely in our routine practice in a day hospital, with no psychometric validation performed on this population. This ancillary objective will not modify the course of the MMSEa validation study since the SPPB is part of the evaluation tools.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elderly Patients, Cognitive Disorder, Alzheimer Disease
Keywords
Cognitive disorders, Alzheimer's disease, Mini Mental State Examination, Geriatry
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Elderly patient (65 and more)
Arm Type
Other
Arm Description
Ederly patients seen in geriatric day hospital, from creole culture.
Intervention Type
Diagnostic Test
Intervention Name(s)
"Antillanisée" Mini Mental State Examination (MMSEa)
Other Intervention Name(s)
MMSEa
Intervention Description
"Antillanisée" version of the Mini Mental State Examination (MMSEa), is a version adaptated to the French West Indies creole culture.
Primary Outcome Measure Information:
Title
Evaluation of the psychometric properties of the questionnaire MMSEa
Description
The following will be measured:
feasibility and acceptability;
validity of structure;
discriminant validity;
predictive validity;
validity of convergence;
reliability (internal consistency,reproducibility (test-retest)).
Time Frame
12 month (+/- 15 days)
Secondary Outcome Measure Information:
Title
Evaluation of the psychometric properties of questionnaire SPPB
Description
The following will be measured:
feasibility and acceptability;
validity of structure;
discriminant validity;
predictive validity;
reliability (internal consistency,reproducibility (test-retest)).
Time Frame
12 month (+/- 15 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject of 65 years old and over
Subject admitted in a geriatric day hospital
Patients of creole culture
Subject having French and/or Creole as mother tongue
Subject able to undergo neuropsychological tests
Subject having given informed consent or, informed consent given by his or her primary caregiver
Subject affiliated to a social security scheme
Exclusion Criteria:
Subject with a disability seriously compromising oral communication (understanding and expression)
Subject with behavioral disorder that does not allow for testing
Subject in general condition not allowing its participation in the tests
Subject involved in another study including an exclusion period still in progress at the time of inclusion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lidvine GODAERT-SIMON, MD
Organizational Affiliation
CHU of Martinique
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Martinique
City
Fort-de-France
State/Province
Martinique
ZIP/Postal Code
97200
Country
France
12. IPD Sharing Statement
Learn more about this trial
Psychometric Validation of the "Antillanisée" Version of the Mini Mental State Examination (MMSEa)
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