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The Study of Reliability and Validity of Pattern Identifications Tool for Cognitive Disorders(PIT-C)

Status Approved

  • First Submitted Date

    2018/01/02

  • Registered Date

    2019/01/10

  • Last Updated Date

    2018/11/16

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0003419
    Unique Protocol ID DJDS NP _16_08
    Public/Brief Title The Study of Reliability and Validity of Pattern Identifications Tool for Cognitive Disorders(PIT-C)
    Scientific Title The Study of Reliability and Validity of Pattern Identifications Tool for Cognitive Disorders(PIT-C)
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number DJDSKH-17-BM-29
    Approval Date 2018-08-31
    Institutional Review Board Name Daejeon University, Dunsan Medical Center, Institutional Review Board
    Institutional Review Board Address 75, Daedeok-daero 176beon-gil, Seo-gu, Daejeon, Republic of Korea
    Institutional Review Board Telephone 042-470-9488
    Data Monitoring Committee
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name In chul Jung
    Title Professor
    Telephone +82-42-470-9129
    Affiliation Daejeon University
    Address Daejeon Dong-gu Daehaglo 62
    Contact Person for Public Queries
    Name Jiyoon Lee
    Title Resident
    Telephone +82-42-470-9561
    Affiliation Dunsan Korean Medicine Hospital of Daejeon University
    Address Daedeogdaelo 176beongil 75, Seo-gu, Daejeon, Korea
    Contact Person for Updating Information
    Name Jiyoon Lee
    Title Resident
    Telephone +82-42-470-9561
    Affiliation Dunsan Korean Medicine Hospital of Daejeon University
    Address Daedeogdaelo 176beongil 75, Seo-gu, Daejeon, Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Multi-center Number of center : 3
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2018-10-17 Actual
    Target Number of Participant 60
    Primary Completion Date
    Study Completion Date
    Recruitment Status by Participating Study Site 1
    Name of Study Daejeon Korean Medicine Hospital of Daejeon University
    Recruitment Status Recruiting
    Date of First Enrollment 2018-10-17 ,
    Recruitment Status by Participating Study Site 2
    Name of Study Wonkwang University Sanbon Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2018-10-17 ,
    Recruitment Status by Participating Study Site 3
    Name of Study Wonkwang University Oriental Medical Hospital, Jeonju
    Recruitment Status Recruiting
    Date of First Enrollment 2018-10-17 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Ministry of Health & Welfare
    Organization Type Government
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Daejeon Korean Medicine Hospital of Daejeon University
    Organization Type Medical Institute
    2. Sponsor Organization
    Organization Name Wonkwang University Sanbon Hospital
    Organization Type Medical Institute
    3. Sponsor Organization
    Organization Name Wonkwang University Oriental Medical Hospital, Jeonju
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    This study is a clinical study to evaluate the reliability and validity of the cognitive impairment assessment tool.
    Early diagnosis and treatment of dementia are particularly important diseases because dementia has not yet been shown to be a fundamental therapeutic agent and has been reported to delay the progress of the disease.
    In Oriental medicine, there is no disease name that accurately responds to modern dementia disease. However, the characteristic memory impairment and cognitive dysfunction in dementia, psychological behavior problems, dementia, dementia, amnesia, epilepsy, hunger, )) And so on.
    Based on the literature review and the expert opinion survey, the self - diagnosis scale of the dementia diagnosed by four types of divergence such as 气虛, 虚虛, 火 热 and 痰) is established, Reliability evaluation Clinical studies were conducted to confirm validity and reliability.
    However, an amendment was made to reflect the results of the clinical study and additional clinical studies were conducted to apply it to mild cognitive impairment other than dementia.
    The evaluators of this study should be two study doctors A and B who have studied and practiced enough to understand the purpose of the research evaluation tool, examination and scoring method. In Screening and Visit 1, after the applicant A judges the appropriateness of the selection criteria and the exclusion criterion for the applicants, the oriental medical practitioners A and B respectively implement the evaluation tool for cognitive impairment. The visit 2 is performed within 7 ± 3 days after screening and visit 1, and the oriental doctor A re-examines the cognitive-dysfunctional assessment tool, the diagnostic tool for the diagnosis of dementia, and the Mini-Mental State Examination-Dementia Screening. The subjects are also screened, pulse test, body composition test, Electroencephalography, and brain oxygen saturation test.
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Case-only
    Time Perspective Prospective  
    Target Number of Participant 60
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    Observation group

    Cohort/Group Description

    In Screening and Visit 1, after the applicant A judges the appropriateness of the selection criteria and the exclusion criterion for the applicants, the oriental medical practitioners A and B respectively implement the evaluation tool for cognitive impairment. The visit 2 is performed within 7±3 days after screening and visit 1, and the doctor A examines the cognitive dysfunction evaluation tool and the dementia
    And the Mini-Mental State Examination-Dementia Screening. The subjects are also screened, pulse test, body composition test, Electroencephalography, and Brain oxygen saturation test.
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    Male and female adults aged 45 to under 85 years who visited for cognitive impairment
    Sampling Method
    This study uses non-random sampling method which is one of the widely used sampling methods in clinical studies.
    We select all the subjects who satisfy the selection criteria at a specific time interval or patients, and draw a random sample of the participants voluntarily participating in the experiment.
    Probabilistic sampling is a time- and cost-intensive method of collecting the entire list of probabilistic probes from the sampling list itself in order to ensure that all members of the population are equally selected. we don't use that method because it is not suitable for extraction method.
    Condition(s)/Problem(s) * (F00-F99)Mental and behavioural disorders 
       (F03)Unspecified dementia 
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    45Year~84Year

    Description

    1) Aged 45 to under 85 old, male and female adults
    2) Those diagnosed with major or mild neurological dysfunction according to the DSM-5 standard
    3) Clinical Dementia Rating 0.5 or 1 person
    4) Korean version of the Montreal Cognitive Assessment Below 22 points
    5) The caregiver or caregiver who cares for the patient or the patient understands the contents of the questionnaire.
    A person
    6) If the patient or his / her legal representative voluntarily agrees to the clinical study consent in writing
    Exclusion Criteria
    1) In cases of dementia due to systemic diseases such as endocrine, infection (eg hypothyroidism, thiamin, rain Thymine B12 deficiency, neurosyphilis, human immunodeficiency virus, encephalitis, etc.)
    2) Psychiatric disorders diagnosed by The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition: schizophrenia, delusional disorder, bipolar disorder Those with a history of major psychiatric disorders such as mental or substance abuse disorders
    3) Those with a seriously unstable medical condition (such as clinical laboratory tests, vital signs, etc. By the judgment of the doctor in charge)
    4) Malignant tumor patients who were not cured
    5) History of head injury that causes loss of consciousness for more than 1 hour
    6) History of traumatic brain hemorrhage, brain tumor, subarachnoid hemorrhage
    7) Those who are at risk of suicide
    8) If the applicant or legal representative does not understand the consent, Occation
    9) Those who are not eligible to participate in this clinical study at the discretion of other researchers
    10) If you participated in other clinical studies within the first month of the study or during the test period If you plan to participate in other clinical studies
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome /Safety/Efficacy
    Primary Outcome(s) 1
    Outcome
    Pattern identification tool for Cognitive Disorders
    Timepoint
    day 0, day 7
    Secondary Outcome(s) 1
    Outcome
    Korean diagnostic tool of dementia
    Timepoint
    day 7
    Secondary Outcome(s) 2
    Outcome
    Pattern identification inventory of Cold, Heat, Deficiency and Excess
    Timepoint
    day 7
    Secondary Outcome(s) 3
    Outcome
    Korean Version of Montreal Cognitive Assessment
    Timepoint
    Screnning
    Secondary Outcome(s) 4
    Outcome
    Korean Version of Expanded Clinical Dementia Rating
    Timepoint
    Screnning
    Secondary Outcome(s) 5
    Outcome
    Neuropsychiatric Inventory–Questionnaire
    Timepoint
    day 7
    Secondary Outcome(s) 6
    Outcome
    Korean Instrumental Activities of Daily Living
    Timepoint
    day 7
    Secondary Outcome(s) 7
    Outcome
    Mini-Mental State Examination-Dementia Screening
    Timepoint
    day 7
    Secondary Outcome(s) 8
    Outcome
    Tongue Diagnosis Examination
    Timepoint
    day 7
    Secondary Outcome(s) 9
    Outcome
    Pulse Diagnosis Examination
    Timepoint
    day 7
    Secondary Outcome(s) 10
    Outcome
    Bioelectrical Impedance Analyzer
    Timepoint
    day 7
    Secondary Outcome(s) 11
    Outcome
    Electroencephalography
    Timepoint
    day 7
    Secondary Outcome(s) 12
    Outcome
    Brain oxygen saturation test
    Timepoint
    day 7
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Not provided at time of Registration
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