Elderly PatientsMMENSEANCT03324711
Psychometric Validation of the "Antillanisée" Version of the Mini Mental State Examination (MMSEa)
A study testing "Antillanisée" Mini Mental State Examination (MMSEa) in people with Elderly Patients and Cognitive Disorder, run by University Hospital Center of Martinique at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Elderly Patients, Cognitive Disorder, Alzheimer Disease
- What is being tested?
- "Antillanisée" Mini Mental State Examination (MMSEa)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2016to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Elderly Patients, Cognitive Disorder, Alzheimer Disease
- Being tested
- "Antillanisée" Mini Mental State Examination (MMSEa)
- Keywords
- Cognitive disorders, Alzheimer's disease, Mini Mental State Examination, Geriatry
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Antillanisée" Mini Mental State Examination (MMSEa)Diagnostic test
Also called MMSEa
"Antillanisée" version of the Mini Mental State Examination (MMSEa), is a version adaptated to the French West Indies creole culture.
| Study group | Role | What they receive |
|---|---|---|
| Elderly patient (65 and more) | Other | Ederly patients seen in geriatric day hospital, from creole culture. Receives: Diagnostic Test: "Antillanisée" Mini Mental State Examination (MMSEa) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)).
Measured: 12 month (+/- 15 days)
Secondary outcomes (1)
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)).
Measured: 12 month (+/- 15 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start15 Nov 2016
- Primary completion11 Apr 2019
- Study completionJul 2019
Why it stopped: Departure of the Principal Investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lidvine GODAERT-SIMON, MD, Principal investigator, CHU of Martinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03324711
- Sponsor's protocol ID
- 15/B/26
- Acronym
- MMENSEA
- Status last verified
- Feb 2022
- First submitted
- 11 Jan 2017
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Validation of the "Antillanisée" Version of the Mini Mental State Examination
- ClinicalTrials.gov ID
- NCT03324711
- Acronym / sponsor ID
- MMENSEA / 15/B/26
- Conditions
- Elderly Patients, Cognitive Disorder, Alzheimer Disease
- Keywords
- Cognitive disorders, Alzheimer's disease, Mini Mental State Examination, Geriatry
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Departure of the Principal Investigator
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Study start
- 15 Nov 2016 (actual)
- Primary completion
- 11 Apr 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 30 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly patient (65 and more) | Other | Diagnostic Test: "Antillanisée" Mini Mental State Examination (MMSEa)Ederly patients seen in geriatric day hospital, from creole culture. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Antillanisée" Mini Mental State Examination (MMSEa)Also: MMSEa"Antillanisée" version of the Mini Mental State Examination (MMSEa), is a version adaptated to the French West Indies creole culture. | Diagnostic test | Elderly patient (65 and more) |
Primary outcome
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)).
1 secondary outcome
Evaluation of the psychometric properties of questionnaire SPPB
Time frame: 12 month (+/- 15 days)
Results and safety
The study was stopped early (reason given: Departure of the Principal Investigator). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lidvine GODAERT-SIMON, MD principal investigator
CHU of Martinique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Antillanisée" Mini Mental State Examination (MMSEa) in people with Elderly Patients and Cognitive Disorder, run by University Hospital Center of Martinique at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Departure of the Principal Investigator). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the psychometric properties of the questionnaire MMSEa (time frame: 12 month (+/- 15 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.