UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038462 |
|---|---|
| Receipt number | R000043831 |
| Scientific Title | The study of evaluation the gatekeeper training program for improving radiation health anxiety |
| Date of disclosure of the study information | 2019/11/01 |
| Last modified on | 2020/05/02 09:35:39 |
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Basic information
Public title
The study of evaluation the gatekeeper training program for improving radiation health anxiety
Acronym
The study of evaluation the gatekeeper training program for improving radiation health anxiety
Scientific Title
The study of evaluation the gatekeeper training program for improving radiation health anxiety
Scientific Title:Acronym
The study of evaluation the gatekeeper training program for improving radiation health anxiety
Region
| Japan |
Condition
Condition
radiation health anxiety and mental disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Measuring the effectiveness of interventions using training programs that include skills necessary for dealing with radiation health anxiety and general mental disorders
Basic objectives2
Others
Basic objectives -Others
For counselors who provide consultation to evacuees due to the nuclear disaster
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) The understanding and maintaining level of the basic knowledge on how to deal with radiation health anxiety and mental health problems
(2) The confidence level of dealing with radiation health anxiety and mental health problems
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Intervention using the developed training program
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All counselors who have worked in the social welfare council in Minami-Soma city and Iitate Village
Key exclusion criteria
Disagreement with intervention
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Seiji |
| Middle name | |
| Last name | YASUMURA |
Organization
Fukushima Medical University
Division name
Department of Public Health School of Medicine
Zip code
960-1295
Address
1-Hikarigaoka, Fukushima City
TEL
024-547-1180
public-h@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Masatsugu |
| Middle name | |
| Last name | ORUI |
Organization
Fukushima Medical University
Division name
Department of Public Health School of Medicine
Zip code
960-1295
Address
1-Hikarigaoka, Fukushima City
TEL
024-547-1180
Homepage URL
oruima@fmu.ac.jp
Sponsor or person
Institute
Department of Mental Health, Graduate School of Medicine, The University of Tokyo.
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Environment, Japan
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
Fukushima Medical University, Department of Public Health School of Medicine
Address
1-Hikarigaoka, Fukushima city
Tel
024-547-1180
oruima@fmu.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
| 2019 | Year | 11 | Month | 01 | 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
Completed
Date of protocol fixation
| 2019 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 27 | Day |
Date of closure to data entry
| 2020 | Year | 02 | Month | 29 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 10 | Day |
Date analysis concluded
| 2020 | Year | 04 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 01 | Day |
Last modified on
| 2020 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043831
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
