UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048037 |
|---|---|
| Receipt number | R000054750 |
| Scientific Title | Development of an educational program for public health nurses to promote local healthcare planning: a randomized controlled trial |
| Date of disclosure of the study information | 2022/07/01 |
| Last modified on | 2023/03/18 13:01:54 |
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Basic information
Public title
Development of an educational program for public health nurses to promote local healthcare planning: a randomized controlled trial
Acronym
Development of an educational program for public health nurses to promote local healthcare planning: a randomized controlled trial
Scientific Title
Development of an educational program for public health nurses to promote local healthcare planning: a randomized controlled trial
Scientific Title:Acronym
Development of an educational program for public health nurses to promote local healthcare planning: a randomized controlled trial
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to conduct an intervention study among administrative public health nurses nationwide to evaluate the effectiveness of a web-based program developed to improve the knowledge and skills of public health nurses in planning.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Competencies related to involvement in health policy
Key secondary outcomes
Knowledge, skills, and attitudes required for planning by public health nurses
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Intervention group: watching a web-based self-learning program (including six contents) regarding local healthcare planning.
Interventions/Control_2
Wait-list control group: after the intervention, they will receive the same educational program.
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
PHNs who are full-time public servants.
Key exclusion criteria
PHNs who do not have Internet access, are employed on a part-time basis.
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | Kyoko |
| Middle name | |
| Last name | Yoshioka |
Organization
The University of Tokyo
Division name
Department of Community Health Nursing, Graduate School of Medicine
Zip code
113-0033
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3597
kyokoy-tky@g.ecc.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Kyoko |
| Middle name | |
| Last name | Yoshioka |
Organization
The University of Tokyo
Division name
Department of Community Health Nursing, Graduate School of Medicine
Zip code
113-0033
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3597
Homepage URL
kyokoy-tky@g.ecc.u-tokyo.ac.jp
Sponsor or person
Institute
Department of Community Health Nursing, Graduate School of Medicine, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
University of Kyoto, University of Hyogo, Chiba Prefectural University of Health Sciences, Mejiro University, Doshisya University
Name of secondary funder(s)
Not applicable.
IRB Contact (For public release)
Organization
Research Ethics Committee of the Faculty of Medicine of the University of Tokyo
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033
Tel
03-5841-0818
ethics@m.u-tokyo.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
東京大学大学院（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://ss1.xrea.com/phn.s28.xrea.com/
Number of participants that the trial has enrolled
273
Results
There were 273 enrollees and 235 participants (118 in the intervention and 117 in the control group). The intervention group showed significantly greater improvement in nine items than the control group on the "A scale of competencies of public health nurses in public health policy (Suzuki, 2014). Among the items of "Knowledge, skills, and attitudes necessary for local healthcare planning," the intervention group significantly improved on 20 items (out of 28) more than the control group.
Results date posted
| 2023 | Year | 03 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Public health nurses who work in the local public governments.
Participant flow
A research explanation was sent to the director public health nurses and asked them to disseminate it to their staff members. Those who wanted to participate in the study registered their participation on the study website.
Adverse events
None.
Outcome measures
"A scale of competencies of public health nurses in public health policy (Suzuki, 2014) and 28 items of "Knowledge, skills, and attitudes necessary for local healthcare planning."
Plan to share IPD
NA.
IPD sharing Plan description
NA.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 01 | Month | 10 | Day |
Date trial data considered complete
| 2023 | Year | 01 | Month | 10 | Day |
Date analysis concluded
| 2023 | Year | 02 | Month | 27 | Day |
Other
Other related information
None.
Management information
Registered date
| 2022 | Year | 06 | Month | 12 | Day |
Last modified on
| 2023 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054750
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/03/18 | 研究変更申請20220728承認書類.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2023/03/18 | データ20230121.xlsx |
