Identification of Neurocognitive Disorders by General Practitioners in Primary Care

NCT ID: NCT03678376

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1018 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-17
• Study Completion Date: 2024-08-17

Brief Summary

Neurocognitive disorders (NCD) are today often largely underdiagnosed or diagnosed in late stages in France. Indeed the ALzheimer COoperative Valuation in Europe (ALCOVE) study stated that about 50% of people living with NCD remain undiagnosed until late severe stages with a deep autonomy loss inducing at risk behaviours and/or behavioural crisis. The French High Authority of Health (Haute Autorité de Santé - HAS) and ALCOVE recommend a timely diagnosis at a time when the specific intervention help to implement secondary or tertiary prevention dynamics that would delay severe complications and help to maintain a reasonable quality of life for both the patient and the caregiver. Moreover, the representatives of the National College of General Practitioners, the French Federation of Memory Centres, the French Federation of Gerontology and Geriatrics, the French Federation of Neurology, the French Society of Psychogeriatrics and the National Plan on Neurodegenerative Diseases designed a hierarchized and tailored diagnosis strategy of NCD promoting a shared diagnosis between the General Practitioner (GP) and specialists of NCD. It therefore appears crucial to determine the diagnosis value of a short duration strategy assessing the complaint, cognition and autonomy in primary care to detect NCD and referring to a specialist to perform the etiological diagnosis. The identification of NCD by GP in primary care (TROCOMEGE) study aims at assessing the positive and negative predictive values of a NCD diagnosis strategy through the assessment of the subjective memory complaint, the cognitive status and the autonomy level in primary care. It relies on the clinical impression of the GP, a cognitive complaint interview for complaint and functional assessment thanks to the General Practitioner assessment of Cognition (GP-Cog, part 2) tool and the cognitive assessment thanks to the Six-Item Cognitive Impairment test (6-CIT).

Conditions

Neurocognitive Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

complaint, cognitive and functional assessments

All patients will be included in a single arm. They will complete an evaluation with their General Practitioner, followed by an evaluation at the Memory Clinic with a specialist (neurologist, geriatrician or psychiatrist).

Group Type: OTHER

complaint, cognitive and functional assessments

Intervention Type: OTHER

The evaluation with their GP is composed of (1-) Clinical impression, (2-) GP-Cog part 2 with patient or their informal caregiver and (3-) 6-CIT test.

The identification of patients at risk of NCD with the new strategy applied by the GP will be compared to the gold standard for diagnosis of NCD at the Memory Clinic, established according to Diagnosis and Statistical Manual of mental disorders (DSM-5) criteria and based on a clinical, neuropsychological evaluation and functional abilities. If needed, a secondary etiological diagnosis procedure will be undertaken following the HAS 2011 recommendation including brain MRI and biology.

Interventions

complaint, cognitive and functional assessments

The evaluation with their GP is composed of (1-) Clinical impression, (2-) GP-Cog part 2 with patient or their informal caregiver and (3-) 6-CIT test.

The identification of patients at risk of NCD with the new strategy applied by the GP will be compared to the gold standard for diagnosis of NCD at the Memory Clinic, established according to Diagnosis and Statistical Manual of mental disorders (DSM-5) criteria and based on a clinical, neuropsychological evaluation and functional abilities. If needed, a secondary etiological diagnosis procedure will be undertaken following the HAS 2011 recommendation including brain MRI and biology.

Intervention Type: OTHER

Other Intervention Names

Evaluation of a new rapid diagnostic strategy for general practitioners assessing complaint, cognition and autonomy in primary care to identify neurocognitive disorders at different stages

Eligibility Criteria

Inclusion Criteria

• Patient aged 65 and over,
• Patient expressing a cognitive complaint (memory, language, sense of time and place disorientation for example) to his/her general practitioner; the complaint can be provided by an informal caregiver and /or, presenting with "at risk" behaviour* possibly related to a NCD (mistaking medicine or forgetting medical consultation, forgetting hot meals, losing him/herself for example…),
• Patients able to understand the specifications of the study and to realize it (vision, audition, language…)
• Patient who has been informed and has consented to the study (himself/herself and by a trusted person/a family member if applicable) as established by the "article L. 1121-8 du Code de la Santé Publique".
• Registered with a social security system

Exclusion Criteria

• Institutionalized patients
• Patients unable to understand the purpose of the study,
• Patients with neurocognitive disorders already diagnosed
• Patients under legal protection
• Patients with auditory or visual disorders which do not allow to perform the assessment
• Patients who do not want to go to the Memory Clinic
• Patients with severe disease commit the prognosis in relatively short term
• Participation to another trial that would interfere with the present study
• Patient with severe anxiety or depression preventing from any reliable neuropsychological assessment.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre Krolak Salmon, Pr

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Hôpital des Charpennes

Villeurbanne, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Pierre Krolak Salmon, Pr

Role: CONTACT

pierre.krolak-salmon@chu-lyon.fr

4 72 43 20 50 ext. +33

Facility Contacts

Pierre Krolak Salmon, Pr

Role: primary

pierre.krolak-salmon@chu-lyon.fr

4 72 43 20 50 ext. +33

Other Identifiers

69HCL18_0041

Identifier Type: -

Identifier Source: org_study_id