UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042882 |
|---|---|
| Receipt number | R000048944 |
| Scientific Title | A comprehensive analysis of psychiatric symptoms after traffic accidents; a multicenter, prospective registry trial. |
| Date of disclosure of the study information | 2021/01/10 |
| Last modified on | 2025/01/17 16:20:55 |
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Basic information
Public title
A comprehensive analysis of psychiatric symptoms after traffic accidents; a multicenter, prospective registry trial.
Acronym
A comprehensive analysis of psychiatric symptoms after traffic accidents; a multicenter, prospective registry trial.
Scientific Title
A comprehensive analysis of psychiatric symptoms after traffic accidents; a multicenter, prospective registry trial.
Scientific Title:Acronym
A comprehensive analysis of psychiatric symptoms after traffic accidents; a multicenter, prospective registry trial.
Region
| Japan |
Condition
Condition
Injured patients due to traffic accidents
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify factors associated with psychiatric symptoms after traffic accident such as pottraumatic stress disorder or depression.
Basic objectives2
Others
Basic objectives -Others
to explore risk factors of outcomes
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Psychiatric disorders such as PTSD or depression at one year after traffic accident
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. patients transferred to hospital due to traffic accidents.
2. patients admitted to hospital.
3. Adults between 20 and 79 years old.
4. able to communicate in Japanese.
Key exclusion criteria
1.Those who are unable to be interviewed (including those with cognitive decline, MMSE < 24,or effects of trauma such as higher brain dysfunction due to severe head injuries).
2.Those who dose not give their consent to participate in the research.
3.Those who were injured by suicide attempt.
4.Those who were judged as inappropriate by the physician/psychologist in charge (e.g., when there is a situation in which conducting an interview may lead to deterioration of the patient's condition)
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takero |
| Middle name | |
| Last name | Terayama |
Organization
National Defense Medical College
Division name
Psychiatry department
Zip code
3590042
Address
Namiki3-2, Tokorozawa, Saitama, Japan
TEL
+81-4-2995-1211
takero.for.medical.journal@gmail.com
Public contact
Name of contact person
| 1st name | Takero |
| Middle name | |
| Last name | Terayama |
Organization
National Defense Medical College
Division name
Psychiatry Department
Zip code
359-0042
Address
Namiki 3-2, Tokorozawa, Saitama, Japan
TEL
+81-4-2995-1211
Homepage URL
takero.for.medical.journal@gmail.com
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Defense Medical College
Address
Namiki3-2, Tokorozawa, Saitama, Japan
Tel
+81-4-2995-1211
ins010@ndmc.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2021 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2030 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research Procedure
1.Date of patient emergency transport
Distribute research pamphlet to the patient or patient's family.
2.Within 1 week after admission
Patients who may meet the eligibility criteria will be given an explanation of the study using a video prepared for the study. Patients with an MMSE score of less than 24 will be excluded at this time. For other self-administered questionnaires, including psychological evaluation scales, responses will be obtained on paper or by using a research tablet (iPad).
3. During hospitalization
For patients who meet the eligibility criteria for fMRI, fMRI will be performed within 14 days from the date of injury.
4. 2,6, and 12 months after injury
Self-administered questionnaires including CAPS-5 and other psychological rating scales will be administered. If the patient is hospitalized, have them complete the questionnaire using the same instrument as within 2 days of admission. The CAPS-5 will be administered at home in the form of a web-based interview using a cell phone, tablet, or PC. The CAPS-5 will be conducted at home in the form of a web-based interview using a mobile phone, tablet, or PC. The psychologist in charge will coordinate the schedule in advance, allowing two weeks before and after the interview.
Management information
Registered date
| 2021 | Year | 01 | Month | 01 | Day |
Last modified on
| 2025 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048944
