Identification of Neurocognitive Disorders by General Practitioners in Primary Care (TROCOMEGE)

September 26, 2023 updated by: Hospices Civils de Lyon
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).

Study Overview

Status

Recruiting

Study Type

Interventional

Enrollment (Estimated)

1018

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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).

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.

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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NCD diagnosis established by the GP by clinical impresson
Time Frame: At inclusion
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
Time Frame: At inclusion
  • 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
Time Frame: At inclusion
  • 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
Time Frame: at 3 months
at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
minor or major NCD diagnosis established by the GP
Time Frame: At inclusion
At inclusion
minor or major NCD diagnosis established by the neuropsychologist using the DSM-5
Time Frame: At 3 months
At 3 months
diagnosis value of each components of the GP strategy solely or in combination
Time Frame: At inclusion
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)
Time Frame: At 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Pierre Krolak Salmon, Pr, Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2020

Primary Completion (Estimated)

August 17, 2024

Study Completion (Estimated)

August 17, 2024

Study Registration Dates

First Submitted

September 11, 2018

First Submitted That Met QC Criteria

September 18, 2018

First Posted (Actual)

September 19, 2018

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL18_0041

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neurocognitive Disorders

Clinical Trials on complaint, cognitive and functional assessments

3
Subscribe