UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046273 |
|---|---|
| Receipt number | R000052799 |
| Scientific Title | The process and promotion of community formation in disaster prevention and prevention. |
| Date of disclosure of the study information | 2022/01/30 |
| Last modified on | 2023/06/07 07:20:24 |
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Basic information
Public title
The process and promotion of community formation in disaster prevention and prevention.
Acronym
The process and promotion of community formation in disaster prevention and prevention.
Scientific Title
The process and promotion of community formation in disaster prevention and prevention.
Scientific Title:Acronym
The process and promotion of community formation in disaster prevention and prevention.
Region
| Japan |
Condition
Condition
Healthy individual (Nurse)
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This paper discusses the promotion and inhibition factors in the process of forming a community of disaster prevention welfare through the utilization of human resources, including experts and non-experts living in the region, and the cooperation of residents.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
An interview survey (once after implementation) will be conducted to evaluate the five areas of the Integrated Framework (CFIR) for implementation research (intervention characteristics, external settings, internal settings, individual characteristics, and processes).
Key secondary outcomes
Implementation outcome indicators (acceptability, appropriateness, feasibility, adoption, adoption) by questionnaire survey (3 times during implementation, 1 time after implementation), group work record (1 time during implementation) and interview survey (1 time after implementation) Evaluate cost / fidelity / penetration / sustainability).
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
Implement using "town disaster mitigation nurse training" as a strategy for forming a district disaster prevention and welfare community.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
A candidate district was selected in consultation with the Regional Comprehensive Support Center in the flood inundation area in the city and the community / health and welfare support team in the city. Next, a nurse who lives or works in a school district that has been approved by the representative of the main community organization of the school district to cooperate in the development of disaster mitigation nurses in the town.
Key exclusion criteria
none
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | miyako |
| Middle name | |
| Last name | saito |
Organization
School Health Sience Yamaguchi University Graduate School of Medicine
Division name
Community/Gerontological Nursing
Zip code
755-8505
Address
1-1-1 Minami Kogushi , Ube Yamaguchi
TEL
0836-22-2826
msaito@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | miyako |
| Middle name | |
| Last name | saito |
Organization
School Health Sience Yamaguchi University Graduate School of Medicine
Division name
Community/Gerontological Nursing
Zip code
755-8505
Address
1-1-1 Minami Kogushi , Ube Yamaguchi
TEL
0836-22-2826
Homepage URL
msaito@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamaguchi University
Address
1-1-1 Minami Kogushi , Ube Yamaguchi
Tel
0836-22-2132
me202@yamaguchi-u.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
| 2022 | Year | 01 | Month | 30 | Day |
Related information
URL releasing protocol
https://www.radish-japan.org/files/conference/RADISH8_proceedings220704.pdf
Publication of results
Partially published
Result
URL related to results and publications
https://www.radish-japan.org/promoteResearch/academic/9thconf/index.html
Number of participants that the trial has enrolled
10
Results
The factors promoting disincentive were: belief in the effectiveness of the welfare community in peacetime for disaster prevention and mitigation (intervention characteristics), awareness of the need for daily interaction between residents (external setting), organisational structure of the voluntary disaster management organisation (internal setting), knowledge of the role of the voluntary disaster management organisation and the district disaster management planning system (individual characteristics).
Results date posted
| 2023 | Year | 06 | Month | 05 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
The publication of the results has been delayed due to the late timing of the original training and because it was before the publication of the results at the conference.
Date of the first journal publication of results
| 2023 | Year | 07 | Month | 01 | Day |
Baseline Characteristics
Nursing professionals such as assistant nurses, nurses, public health nurses and midwives who live or work in the target area.
Participant flow
Recruitment of participants is based on district (primary school unit) newsletters and calls from local comprehensive support centres, etc.
Adverse events
As the training will be held during a corona epidemic, a risk of infection is expected as the training will be held in a face-to-face group setting. Questionnaires and interviews will be time-constrained to 10 and 60 minutes respectively.
Outcome measures
Inhibiting and facilitating factors were assessed in terms of the structural properties of the integrated framework for implementation research: Intervention characteristics, External setting, Internal setting, Individual characteristics and Process. Processes.
Implementation outcome items were assessed in terms of acceptability, adoption, appropriateness, effectiveness, feasibility, fidelity, implementation costs, dissemination and sustainability.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 03 | Day |
Last modified on
| 2023 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052799
