Self-screening of Cognitive Impairment in Primary Care

Alzheimer Disease Clinical Trial

— 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04019665
• Other study ID #: PI2018_843_0024
• Status: Withdrawn
• Phase: N/A
• Start date: May 27, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognition Disorder
• Cognition Disorders
• Cognitive Dysfunction

Intervention

Other:
• MMSE (mini mental state examination)
mini mental state examination takes place during the consultation. The consultation is a general or post-emergency geriatric consultation.
• SAGE (Self-Administered Gerocognitive Exam)
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.

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	day 0
Primary	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.	10 days
Primary	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.	10 days