- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03324711
Psychometric Validation of the "Antillanisée" Version of the Mini Mental State Examination (MMSEa) (MMENSEA)
Psychometric Validation of the "Antillanisée" Version of the Mini Mental State Examination
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Martinique
-
Fort-de-France, Martinique, France, 97200
- CHU de Martinique
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
OTHER: Elderly patient (65 and more)
Ederly patients seen in geriatric day hospital, from creole culture.
|
"Antillanisée" version of the Mini Mental State Examination (MMSEa), is a version adaptated to the French West Indies creole culture.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of the psychometric properties of the questionnaire MMSEa
Time Frame: 12 month (+/- 15 days)
|
The following will be measured:
|
12 month (+/- 15 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of the psychometric properties of questionnaire SPPB
Time Frame: 12 month (+/- 15 days)
|
The following will be measured:
|
12 month (+/- 15 days)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lidvine GODAERT-SIMON, MD, CHU of Martinique
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15/B/26
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