Self-screening of Cognitive Impairment in Primary Care

Not Applicable

Withdrawn

• Conditions: Cognition Disorder; Alzheimer Disease
• Interventions: Other: MMSE (mini mental state examination); Other: SAGE (Self-Administered Gerocognitive Exam)

• Registration Number: NCT04019665
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-11
• Study First Submitted QC: 2019-07-12
• Study First Posted: 2019-07-15
• Study Start: 2020-05-27
• Primary Completion: 2020-11-01
• Study Completion: 2020-12-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SAGE and MMSE score	MMSE (mini mental state examination)	-
SAGE and MMSE score	SAGE (Self-Administered Gerocognitive Exam)	-

Primary Outcome Measures

Name	Time	Method
MMSE Score at general or post emergency geriatric consultation	day 0	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	10 days	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	10 days	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.

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France