UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032343 |
|---|---|
| Receipt number | R000036880 |
| Scientific Title | Development of Specific Care Strateigies to maintain and recover survivors' health after Disasters |
| Date of disclosure of the study information | 2018/04/22 |
| Last modified on | 2019/10/23 09:56:09 |
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Basic information
Public title
Development of Specific Care Strateigies to maintain and recover survivors' health after Disasters
Acronym
Intervention program to prevent PTSR and depression among nurses after Kumamoto earthquake.
Scientific Title
Development of Specific Care Strateigies to maintain and recover survivors' health after Disasters
Scientific Title:Acronym
Intervention program to prevent PTSR and depression among nurses after Kumamoto earthquake.
Region
| Japan |
Condition
Condition
PTSR and depressionstates
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to conduct a therapeutic intervention program among healthcare and social services providers affected by disasters,and to describe the feasibility,relevance and acceptability of the programme and draw the hypothesis about the programme's impact on the prevention of PTSD and depression.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
CES-D,DCTR,PRIMARY ptsd,sf-8
Key secondary outcomes
turon over rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
A therapeutic programme is dynamic grouptherapy and self-care intervention.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A person who meets all the condition below is considered as a participant of the research
a) A person has who have an official certification of LTC needs level 3 or more (60 years old or more and need supports for daily life) issued by a local municipality he/she is belong to.
b) A person who agrees and signs the informed consent of this research
Key exclusion criteria
A person who meets one or more condition below is considered as not-relevant for a participant of the research
c) A person diagnosed as dementia
d) A person who has cognitive decline or emotional instability and has difficulty to communicate with other people
e) A person considered who has serious mental or physical problem by the assessment by researchers (medical and mental health experts) at the time of obtaining informed consent
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shiori USAMI |
Organization
Faculty of Life Science,Kumamoto University
Division name
Deptment of nursing
Zip code
Address
4-24-1,Kuhonji,Kumamoto City,Kumamoto Prefecture
TEL
0963735470
susami@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shiori USAMI |
Organization
Kumamoto University
Division name
Faculty of life sciences,kumamoto university
Zip code
Address
4-24-1,kuhonji,chuo-ku,kumamoto city
TEL
0963735470
Homepage URL
susami@kumamoto-u.ac.jp
Sponsor or person
Institute
Faculty of life sciences,Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
WHO
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
WHO
Other related organizations
Co-sponsor
University of Hyogo
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 04 | Month | 22 | 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
| 2017 | Year | 11 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 23 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 22 | Day |
Last modified on
| 2019 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036880
