Self-screening of Cognitive Impairment in Primary Care

NCT04019665 | Withdrawn

• 1 other identifier: PI2018_843_0024
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognition Disorder; Alzheimer Disease

Keywords

Cognition Disorder; Alzheimer Disease; MMSE; SAGE

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

SAGE and MMSE score

OTHER

Other: MMSE (mini mental state examination); Other: SAGE (Self-Administered Gerocognitive Exam)

Interventions

MMSE (mini mental state examination) OTHER

mini mental state examination takes place during the consultation. The consultation is a general or post-emergency geriatric consultation.

SAGE and MMSE score

SAGE (Self-Administered Gerocognitive Exam) OTHER

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.

SAGE and MMSE score

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects from three Picard general practitioner's practice
• 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

You may not qualify if:

• major visual disorders
• legal safeguard
• diagnosis of neuro-cognitive disorder

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

MeSH Terms

Conditions

Cognition Disorders; Alzheimer Disease

Interventions

Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Federspiel, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Deschamps, MD

  Montdidier

  PRINCIPAL INVESTIGATOR

• Briat-Lagache, MD

  Hangest-en-Santerre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 15, 2019
• Study Start: May 27, 2020
• Primary Completion: November 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)