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
CRIS Registration Number |
KCT0003419 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Multi-center Number of center : 3 | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Ministry of Health & Welfare |
Organization Type | Government |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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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
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. |
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8. Study Design
Study Type | Observational Study |
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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
Study Population Description | Male and female adults aged 45 to under 85 years who visited for cognitive impairment |
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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)
Type of Primary Outcome | /Safety/Efficacy | |
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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
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Not provided at time of Registration |
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