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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03324711
Other study ID # 15/B/26
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date November 15, 2016
Est. completion date July 2019

Study information

Verified date February 2022
Source University Hospital Center of Martinique
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 75
Est. completion date July 2019
Est. primary completion date April 11, 2019
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
France CHU de Martinique Fort-de-France Martinique

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Center of Martinique

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)).
12 month (+/- 15 days)
Secondary 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)).
12 month (+/- 15 days)
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