Self-screening of Cognitive Impairment in Primary Care (OCEANE)
Primary Purpose
Cognition Disorder, Alzheimer Disease
Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MMSE (mini mental state examination)
SAGE (Self-Administered Gerocognitive Exam)
Sponsored by
About this trial
This is an interventional other trial for Cognition Disorder focused on measuring Cognition Disorder, Alzheimer Disease, MMSE, SAGE
Eligibility Criteria
Inclusion Criteria:
- Subjects from three Picard general practitioner's practice
- 60 years old or more
- patients who accept to complete the tests
- with ou without cognitive complaint
- patients able to read and write
- affiliated to social security system
Exclusion Criteria:
- major visual disorders
- legal safeguard
- diagnosis of neuro-cognitive disorder
Sites / Locations
- CHU Amiens
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
SAGE and MMSE score
Arm Description
Outcomes
Primary Outcome Measures
MMSE Score at general or post emergency geriatric consultation
The Mini-Mental State Exam (MMSE) is a widely used test of cognitive function among the elderly; it includes tests of orientation, attention, memory, language and visual-spatial skills. The Mini-Mental State Examination (MMSE) or Folstein test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment.
Sage test done at home
SAGE (Self-Administered Gerocognitive Exam) test, and was developed by the Ohio State University Wexner Medical Center. Average time to complete the test is 15 minutes. The maximum score is 22. A score of 17 and above is considered normal.
Concordance between the MMSE test score done at consultation and the sage test core done at home
The Mini-Mental State Exam (MMSE) is a widely used test of cognitive function among the elderly; it includes tests of orientation, attention, memory, language and visual-spatial skills. The Mini-Mental State Examination (MMSE) or Folstein test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. SAGE (Self-Administered Gerocognitive Exam) test, and was developed by the Ohio State University Wexner Medical Center. Average time to complete the test is 15 minutes. The maximum score is 22. A score of 17 and above is considered normal.
Secondary Outcome Measures
Full Information
NCT ID
NCT04019665
First Posted
July 11, 2019
Last Updated
March 21, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT04019665
Brief Title
Self-screening of Cognitive Impairment in Primary Care
Acronym
OCEANE
Official Title
Self-screening of Cognitive Impairment in Primary Care: a Comparative Study Between a Test Based on SAGE at Home and MMSE at Doctor's Office in Picardie
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Withdrawn
Why Stopped
no participants enrolled
Study Start Date
May 27, 2020 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
According to 2011 HAS recommendations, early detection of Alzheimer disease is the major objective in order to allow an earlier care and support. These recommendations strengthen general practitioner role, who plays a key role in the identification of cognitively impaired patients. HAS recommendations are the use of MMSE like test (Mini Mental State Examination) at general practitioner office. A self-screening test, without medical presence, would allow a self-administered cognitive assessment by the patient. A review of the literature about self-administered cognitive tests has been realized. The Self-Administered Gerocognitive Examination (SAGE) has been chosen. It is a brief, valid and reliable cognitive assessment tool, rated on 22 points, which allows an early detection of cognitive impairment, with a sensitivity close to the MMSE test. Nevertheless, SAGE has never been tested at home without medical supervision. In this study, the investigators will determine if SAGE scores at home correlates with MMSE scores at general practitioner office.
Patients with inclusion criteria will be recruited during the general practitioner consultation and will have a clinical assessment included MMSE and clinical data collection. Then, SAGE will be given to the patient in order to be completed at home without medical supervision and send to the general practitioner.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognition Disorder, Alzheimer Disease
Keywords
Cognition Disorder, Alzheimer Disease, MMSE, SAGE
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SAGE and MMSE score
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
MMSE (mini mental state examination)
Intervention Description
mini mental state examination takes place during the consultation. The consultation is a general or post-emergency geriatric consultation.
Intervention Type
Other
Intervention Name(s)
SAGE (Self-Administered Gerocognitive Exam)
Intervention Description
SAGE test contains a series of questions that assess the cognitive functioning. Sage was developed by the Ohio State University Wexner Medical Center. it's an online, at-home, self-screening dementia tool that has been scientifically evaluated, and it's demonstrated good results in accurately identifying cognitive deficits.
Primary Outcome Measure Information:
Title
MMSE Score at general or post emergency geriatric consultation
Description
The Mini-Mental State Exam (MMSE) is a widely used test of cognitive function among the elderly; it includes tests of orientation, attention, memory, language and visual-spatial skills. The Mini-Mental State Examination (MMSE) or Folstein test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment.
Time Frame
day 0
Title
Sage test done at home
Description
SAGE (Self-Administered Gerocognitive Exam) test, and was developed by the Ohio State University Wexner Medical Center. Average time to complete the test is 15 minutes. The maximum score is 22. A score of 17 and above is considered normal.
Time Frame
10 days
Title
Concordance between the MMSE test score done at consultation and the sage test core done at home
Description
The Mini-Mental State Exam (MMSE) is a widely used test of cognitive function among the elderly; it includes tests of orientation, attention, memory, language and visual-spatial skills. The Mini-Mental State Examination (MMSE) or Folstein test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. SAGE (Self-Administered Gerocognitive Exam) test, and was developed by the Ohio State University Wexner Medical Center. Average time to complete the test is 15 minutes. The maximum score is 22. A score of 17 and above is considered normal.
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects from three Picard general practitioner's practice
60 years old or more
patients who accept to complete the tests
with ou without cognitive complaint
patients able to read and write
affiliated to social security system
Exclusion Criteria:
major visual disorders
legal safeguard
diagnosis of neuro-cognitive disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Federspiel, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Deschamps, MD
Organizational Affiliation
Montdidier
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Briat-Lagache, MD
Organizational Affiliation
Hangest-en-Santerre
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80480
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Self-screening of Cognitive Impairment in Primary Care
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