Identification of Neurocognitive Disorders by General Practitioners in Primary Care

Study Overview
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Brief Summary
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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).

Official Title
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Identification of Neurocognitive Disorders by General Practitioners in Primary Care

Conditions
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Neurocognitive Disorders

Intervention / Treatment
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* Other: complaint, cognitive and functional assessments


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: complaint, cognitive and functional assessments<br>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). | Other: complaint, cognitive and functional assessments<br>* 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.<br>* Other 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;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NCD diagnosis established by the GP by clinical impresson | the GP will have to respond to the following issues 1- Does he think the patient presents a suspect cognitive complaint (Yes/No) 2- does he think the patient presents with a NCD (Yes/No), | At inclusion | 
| NCD diagnosis established by the GP using the GP-Cog part 2 | a GP-cog score of 0-3 means no significant cognitive impairment a GP-cog score of 4-6 means significant cognitive complaint | At inclusion | 
| NCD diagnosis established by the GP using the 6-CIT test | a 6-CIT score between 0 and 7 means normal, referral not indicated at present a 6-CIT score between 8 and 28 means mild or significant cognitive impairment | At inclusion | 
| NCD diagnosis established in the memory clinics as reference by the Neuropsychologist using the DSM-5 |  | at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| minor or major NCD diagnosis established by the GP |  | At inclusion | 
| minor or major NCD diagnosis established by the neuropsychologist using the DSM-5 |  | At 3 months | 
| diagnosis value of each components of the GP strategy solely or in combination | Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value, likelihood ratios will be calculated. | At inclusion | 
| level of cognitive performance established with the Mini Mental State Examination (MMSE) | A MMSE<18 being is considered as abnormal, MMSE between 18-23 is considered as questionable and MMSE >=24 is considered as normal) | At 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diagnostic strategy, Neurocognitive disorders, Primary Care