UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051502 |
|---|---|
| Receipt number | R000058737 |
| Scientific Title | District disaster reduction welfare community formation process and implementation outcome evaluation through training of community disaster reduction nurses. |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2024/07/08 18:54:24 |
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Basic information
Public title
District disaster reduction welfare community formation process and implementation outcomes evaluation through training of community disaster reduction nurses.
Acronym
District disaster reduction welfare community formation process and implementation outcome evaluation through training of community disaster reduction nurses.
Scientific Title
District disaster reduction welfare community formation process and implementation outcome evaluation through training of community disaster reduction nurses.
Scientific Title:Acronym
District disaster reduction welfare community formation process and implementation outcome evaluation through training of community disaster reduction nurses.
Region
| Japan |
Condition
Condition
Healthy individual(Nurse)
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To implement the 'community disaster reduction nurse development training' in collaboration with district disaster reduction-related residents, and to identify the disaster reduction welfare community formation process and implementation outcomes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Modified RE-AIM model 'PAIREM'.
(1) Plan (2) Adoption (3) Implementation (4) Reach (5) Efficacy/Effectiveness (6) Maintenace
Key secondary outcomes
Implementation Outcome Indicators
(1) Acceptability (2) Adaptation (3) Adoption (4) Appropriateness (5) Feasibility (6) Fidelity (7) Maintenance (8) Penetration (9) 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 a three-session course (once a month) on 'Community Disaster Reduction Nurse Training' as an implementation strategy for the formation of district disaster reduction welfare communities.
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Select two or three districts (primary school zones) in the city that are in a flood-prone and landslide-prone districts shall be those that have agreed to collaborate in the 'Community Disaster Reduction Nurse Training' after consulting with disaster reduction officials and city officials in the districts concerned.
Nurses and disaster management personnel who live or work in the area and have attended the training should be targeted.
Key exclusion criteria
none
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Miyako |
| Middle name | |
| Last name | Saito |
Organization
Graduate School of Medicine, Yamaguchi University
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
Graduate School of Medicine, Yamaguchi University
Division name
Community/Gerontological Nursing
Zip code
755-8505
Address
1-1-1 Minami Kogushi Ube Yamaguchi
TEL
0836-22-2826
Homepage URL
https://ds0n.cc.yamaguchi-u.ac.jp/~cldpm/index.html
msaito@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University
Institute
Department
Personal name
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamaguchi University Medical School Hospital
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
| 2023 | Year | 09 | 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
12
Results
They were able to learn about 'the need for disaster reduction measures and specific measures according to regional characteristics' and 'the importance of daily human connections in the community'. 70% of the community disaster reduction nurses utilized the information in their activities. Face-to-face activities were found to be effective in terms of increasing motivation to work in the community and building friendships and relationships with the residents involved.
Results date posted
| 2024 | Year | 07 | Month | 03 | Day |
Results Delayed
Results Delay Reason
It is due to be published at the Japanese Society of Disaster Nursing in September 2024.
Date of the first journal publication of results
Baseline Characteristics
11 nurses, 1 assistant nurse, 7 nurses with more than 10 years of nursing experience, none had attended training in disaster nursing or had experience in support activities.
Participant flow
Adverse events
There is a time constraint of 10-15 minutes for the questionnaire survey. Due to face-to-face group training, a risk of infection is foreseen during infectious disease outbreaks.
Outcome measures
The six phases of the evaluation of the modified RE-AIM model "PAIRERM" are organized based on (1) planning, (2) adoption, (3) implementation, (4) achievement, (5) effectiveness and (6) continuation, and the five phases (1) to (5) are analyses to evaluate the implementation outcomes of district disaster prevention welfare community formation and training programmed evaluation at the end of training.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 07 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 02 | Day |
Last modified on
| 2024 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058737
