Clinical trial NCT03678376: Identification of Neurocognitive Disorders by General Practitioners in Primary Care
Official title: Identification of Neurocognitive Disorders by General Practitioners in Primary Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neurocognitive Disorders
Keywords: Diagnostic strategy
Neurocognitive disorders
Primary Care
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-09-19
Enrollment: 1018
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).


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.

Primary outcomes:
measure: NCD diagnosis established by the GP by clinical impresson
timeFrame: At inclusion
measure: NCD diagnosis established by the GP using the GP-Cog part 2
timeFrame: At inclusion
measure: NCD diagnosis established by the GP using the 6-CIT test
timeFrame: At inclusion
measure: NCD diagnosis established in the memory clinics as reference by the Neuropsychologist using the DSM-5
timeFrame: at 3 months
Secondary outcomes:
measure: minor or major NCD diagnosis established by the GP
timeFrame: At inclusion
measure: minor or major NCD diagnosis established by the neuropsychologist using the DSM-5
timeFrame: At 3 months
measure: diagnosis value of each components of the GP strategy solely or in combination
timeFrame: At inclusion
measure: level of cognitive performance established with the Mini Mental State Examination (MMSE)
timeFrame: At 3 months
Other outcomes:
Locations:
city: Villeurbanne
country: France
facility: Hôpital des Charpennes
Study officials:
affiliation: Hospices Civils de Lyon
name: Pierre Krolak Salmon, Pr
role: PRINCIPAL_INVESTIGATOR
References: