Identification of Neurocognitive Disorders by General Practitioners in Primary Care (TROCOMEGE)
Primary Purpose
Neurocognitive Disorders
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
complaint, cognitive and functional assessments
Sponsored by
About this trial
This is an interventional diagnostic trial for Neurocognitive Disorders focused on measuring Diagnostic strategy, Neurocognitive disorders, Primary Care
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.
Sites / Locations
- Hôpital des CharpennesRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
complaint, cognitive and functional assessments
Arm Description
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).
Outcomes
Primary Outcome Measures
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),
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
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
NCD diagnosis established in the memory clinics as reference by the Neuropsychologist using the DSM-5
Secondary Outcome Measures
minor or major NCD diagnosis established by the GP
minor or major NCD diagnosis established by the neuropsychologist using the DSM-5
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.
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)
Full Information
NCT ID
NCT03678376
First Posted
September 11, 2018
Last Updated
September 26, 2023
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT03678376
Brief Title
Identification of Neurocognitive Disorders by General Practitioners in Primary Care
Acronym
TROCOMEGE
Official Title
Identification of Neurocognitive Disorders by General Practitioners in Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 17, 2020 (Actual)
Primary Completion Date
August 17, 2024 (Anticipated)
Study Completion Date
August 17, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurocognitive Disorders
Keywords
Diagnostic strategy, Neurocognitive disorders, Primary Care
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1018 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
complaint, cognitive and functional assessments
Arm Type
Other
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
complaint, cognitive and functional assessments
Other Intervention Name(s)
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
Intervention Description
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.
Primary Outcome Measure Information:
Title
NCD diagnosis established by the GP by clinical impresson
Description
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),
Time Frame
At inclusion
Title
NCD diagnosis established by the GP using the GP-Cog part 2
Description
a GP-cog score of 0-3 means no significant cognitive impairment
a GP-cog score of 4-6 means significant cognitive complaint
Time Frame
At inclusion
Title
NCD diagnosis established by the GP using the 6-CIT test
Description
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
Time Frame
At inclusion
Title
NCD diagnosis established in the memory clinics as reference by the Neuropsychologist using the DSM-5
Time Frame
at 3 months
Secondary Outcome Measure Information:
Title
minor or major NCD diagnosis established by the GP
Time Frame
At inclusion
Title
minor or major NCD diagnosis established by the neuropsychologist using the DSM-5
Time Frame
At 3 months
Title
diagnosis value of each components of the GP strategy solely or in combination
Description
Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value, likelihood ratios will be calculated.
Time Frame
At inclusion
Title
level of cognitive performance established with the Mini Mental State Examination (MMSE)
Description
A MMSE<18 being is considered as abnormal, MMSE between 18-23 is considered as questionable and MMSE >=24 is considered as normal)
Time Frame
At 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre Krolak Salmon, Pr
Phone
4 72 43 20 50
Ext
+33
Email
pierre.krolak-salmon@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Krolak Salmon, Pr
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital des Charpennes
City
Villeurbanne
ZIP/Postal Code
69100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Krolak Salmon, Pr
Phone
4 72 43 20 50
Ext
+33
Email
pierre.krolak-salmon@chu-lyon.fr
12. IPD Sharing Statement
Learn more about this trial
Identification of Neurocognitive Disorders by General Practitioners in Primary Care
We'll reach out to this number within 24 hrs