Self-screening of Cognitive Impairment in Primary Care (OCEANE)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Alzheimer Disease; Cognition Disorder
• Intervention / Treatment: Other: MMSE (mini mental state examination); Other: SAGE (Self-Administered Gerocognitive Exam)

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guillaume Deschasse, MD; Phone Number: (33)322088000; Email: deschasse.guillaume@chu-amiens.fr

Study Locations

• France
  • Amiens, France, 80480
    • CHU Amiens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: SAGE and MMSE score

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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Investigators: Principal Investigator: Federspiel, MD, CHU Amiens; Principal Investigator: Deschamps, MD, Montdidier; Principal Investigator: Briat-Lagache, MD, Hangest-en-Santerre

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2020
• Primary Completion (Actual): November 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: July 11, 2019
• First Submitted That Met QC Criteria: July 12, 2019
• First Posted (Actual): July 15, 2019

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Alzheimer Disease; SAGE; Cognition Disorder; MMSE
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Cognitive Dysfunction; Cognition Disorders
• Other Study ID Numbers: PI2018_843_0024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No