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Psychometric Validation of the "Antillanisée" Version of the Mini Mental State Examination (MMSEa) (MMENSEA)

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ClinicalTrials.gov Identifier: NCT03324711
Recruitment Status : Recruiting
First Posted : October 30, 2017
Last Update Posted : October 30, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital Center of Martinique

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.


Condition or disease Intervention/treatment Phase
Elderly Patients Cognitive Disorder Alzheimer Disease Diagnostic Test: "Antillanisée" Mini Mental State Examination (MMSEa) Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Psychometric Validation of the "Antillanisée" Version of the Mini Mental State Examination
Study Start Date : November 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Elderly patient (65 and more)
Ederly patients seen in geriatric day hospital, from creole culture.
Diagnostic Test: "Antillanisée" Mini Mental State Examination (MMSEa)
"Antillanisée" version of the Mini Mental State Examination (MMSEa), is a version adaptated to the French West Indies creole culture.
Other Name: MMSEa




Primary Outcome Measures :
  1. Evaluation of the psychometric properties of the questionnaire MMSEa [ Time Frame: 12 month (+/- 15 days) ]

    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 :
  1. Evaluation of the psychometric properties of questionnaire SPPB [ Time Frame: 12 month (+/- 15 days) ]

    The following will be measured:

    • feasibility and acceptability;
    • validity of structure;
    • discriminant validity;
    • predictive validity;
    • reliability (internal consistency,reproducibility (test-retest)).



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03324711


Contacts
Contact: Lidvine GODAERT-SIMON, MD lidvine.godaert-simon@chu-martinique.fr
Contact: Yann MOPSUS yann.mopsus@chu-martinique.fr

Locations
France
CHU de Martinique Recruiting
Fort-de-France, Martinique, France, 97200
Contact: Yann MOPSUS       yann.mopsus@chu-martinique.fr   
Principal Investigator: Lidvine GODAERT-SIMON, MD         
Sponsors and Collaborators
University Hospital Center of Martinique
Investigators
Principal Investigator: Lidvine GODAERT-SIMON, MD CHU of Martinique

Responsible Party: University Hospital Center of Martinique
ClinicalTrials.gov Identifier: NCT03324711     History of Changes
Other Study ID Numbers: 15/B/26
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017

Keywords provided by University Hospital Center of Martinique:
Cognitive disorders
Alzheimer's disease
Mini Mental State Examination
Geriatry

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders