UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048421 |
|---|---|
| Receipt number | R000054818 |
| Scientific Title | Developing a program for public health nurses to enhance the implementation of public health projects |
| Date of disclosure of the study information | 2022/07/31 |
| Last modified on | 2024/01/16 13:36:02 |
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Basic information
Public title
Developing a program for public health nurses to enhance the implementation of public health projects
Acronym
Developing a program for public health nurses to enhance the implementation of public health projects (randomized controlled trial)
Scientific Title
Developing a program for public health nurses to enhance the implementation of public health projects
Scientific Title:Acronym
Developing a program for public health nurses to enhance the implementation of public health projects (randomized controlled trial)
Region
| Japan |
Condition
Condition
Implementation capabilities of public health nurses
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of job training program to build implementation capabilities for public health nurses who have under 6 year work experience
Basic objectives2
Others
Basic objectives -Others
Development of public health nursing competency
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Implementation Degree Assessment Sheet for
health program(IDAS)
Key secondary outcomes
Passing status of required passing points
Research Utilization Competency Scale
Simulation Design Scale Japanese Version(National League for Nursing Framework)
Utrecht Work Engagement Scale Japanese Version
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
participants in the intervention group have online training that helps them to acquire an
ability to implement public health projects
Interventions/Control_2
participants in the intervention group have online training that helps them to acquire an
ability to implement public health projects
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
a person who works a regular job as a public health nurse at public health section under
six years of experience as of April 2022
in addition,the person who is able to participate in all web based program
Key exclusion criteria
a person who is off on maternity leave or parental leave or sick leave
a person who is not available to participate in all online program
Target sample size
174
Research contact person
Name of lead principal investigator
| 1st name | Reiko |
| Middle name | |
| Last name | Okamoto |
Organization
Osaka University graduate school of medicine
Division name
Division of health sciences
Zip code
5650871
Address
1-7 yamadaoka, suita-shi, osaka-fu, Japan
TEL
06-6879-2550
reiko@sahs.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Reiko |
| Middle name | |
| Last name | Okamoto |
Organization
Osaka University graduate school of medicine
Division name
Division of health sciences
Zip code
5650871
Address
1-7 yamadaoka, suita-shi, osaka-fu, Japan
TEL
06-6879-2550
Homepage URL
reiko@sahs.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka university
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Clinical Research Review Committee
Address
Yamadaoka 2-15, Suita City, Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-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 | 07 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
194
Results
Total IDAS score in the intervention compared with the control groups at time3 was 97.98vs85.05(mean),p=0.01,Cohen's d=0.50(FAS),d=0.48(PPS). The RUC score at time 3 was36.77 vs 32.02(mean),p=0.00, d=0.56(FAS). The UWES score at time3 was 25.22vs 23.14,p=0.25,d=0.21(FAS). The results of the IDAS, the RUC and the UWES analyzed by ANCOVA were significant results(p<0.00). The result of level of understanding was at T3 was 42vs24(median),P<0.00 and Quede`s ANCOVA(p<0.00).
Results date posted
| 2024 | Year | 01 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Full analysis set (FAS) was 152 of participants( intervention; n=69, control;n=83). Per-protocol set(PPS) was 104 of those(intervention;n=44,control;n=60). Mean age was 29.4 years old in the intervention group and 28.6 years old in the control group (p=0.70 u-test). The experience of implementation project was that 18 of participants had the experience in the intervention group compared with 34 of those in control group (p=0.028 Fisher's exact test). Other categories of baseline characteristics, such as affiliation, years of experience as a public health nurse, academic history did not find significant differences between intervention and control groups.
Participant flow
A total of the 203 PHNs applied for the study and six people were not eligible for participation following conditions; three did not fulfill the include criteria, like without writing consent: others met an exclusion criterion, working part-time. 197 participants were divided into the intervention group (n=98) and the control group(n=99). After allocation of the groups, a participation in the intervention was excluded due to ineligible for this trial and one in the control enrolled twice times, and the other in the control declined due to technical issues. At the four weeks after intervention, there were 37of the participants in the intervention and 32 of those in the control who left the study without response.
Adverse events
None
Outcome measures
Main outcome:IDAS( implementation degree assessment sheet for health program).
Sub outcome :RUC(Research Utilization Competency scale), UWES(Utrecht Work Engagement Scale),the level of understanding,
total scores for satisfaction and confidence. comment, the number of days viewed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 07 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 21 | Day |
Last modified on
| 2024 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054818
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
