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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042882
Receipt No. 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 2021/01/01

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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
Email 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
Email takero.for.medical.journal@gmail.com

Sponsor
Institute National Defense Medical College
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2021 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2021 Year 01 Month 15 Day
Last follow-up date
2023 Year 12 Month 31 Day
Date of closure to data entry
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
2021 Year 01 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048944

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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