UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051509 |
|---|---|
| Receipt number | R000058761 |
| Scientific Title | Development of ICT-based public health nurse activity algorithm and evaluation method and its application to human resource development by supervising public health nurses: Development of the ICT tool |
| Date of disclosure of the study information | 2023/08/01 |
| Last modified on | 2023/08/05 14:53:36 |
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Basic information
Public title
Development of ICT-based public health nurse activity algorithm and evaluation method and its application to human resource development by supervising public health nurses: Development of the ICT tool
Acronym
Development of a recording system for public health nurses' activities
Scientific Title
Development of ICT-based public health nurse activity algorithm and evaluation method and its application to human resource development by supervising public health nurses: Development of the ICT tool
Scientific Title:Acronym
Development of a recording system for public health nurses' activities
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the reliability and validity of the public health nurse activity evaluation index and algorithm
Develop a prototype version of the ICT tool and conduct conceptual validation
Basic objectives2
Others
Basic objectives -Others
Based on the results of the national survey conducted in FY2022, a pilot study using a prototype version of the ICT tool will be conducted in FY2023, and the main study will be conducted in FY2024, expanding to the target regions. Through this study, we aim to visualize and standardize tacit knowledge related to public health nurse activities, develop efficient and effective public health nurse activities that contribute to improving the quality of life of residents, extending healthy life expectancy, and reducing health disparities, and promote human resource development for public health nurses.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Necessity of public health nurse activity
Key secondary outcomes
System usability
Subjective work load
Public health nurse activity process evaluation index
Utilization of the recording system (qualitative)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Public health nurses working in the municipalities included in the study
Key exclusion criteria
Those who do not wish to participate in the study
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Kyoko |
| Middle name | |
| Last name | Yoshioka-Maeda |
Organization
The University of Tokyo
Division name
Graduate School of Medicine
Zip code
1130033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3597
chiiki-jim@m.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshige |
| Middle name | |
| Last name | Matsumoto |
Organization
The University of Tokyo
Division name
Graduate School of Medicine
Zip code
1130033
Address
Hongo7-3-1 Bunkyo-ku, Tokyo, Japan
TEL
03-5841-3597
Homepage URL
hiroshige-tky@g.ecc.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokyo, Clinical Research Review Board
Address
Hongo7-3-1 Bunkyo-ku, Tokyo, Japan
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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Longitudinal observational study of up to 1 year and 6 months
At the beginning of the study, participants' personal attributes, career ladder, system usability of the daily reporting system previously used, subjective workload, and public health nurse activity process evaluation index will be measured
During the study period, participants will record their daily activities using a prototype ICT tool (daily record system). The necessity score for public health nurse activities is automatically calculated in the record of individual support, and the recorder evaluates the validity of this score.
During the study period, qualitative interview survey will be conducted on the utilization of the recording system.
At the end of the study, system usability, subjective workload, and public health nurse activity process evaluation indicators of the daily reporting system will be measured
Management information
Registered date
| 2023 | Year | 07 | Month | 03 | Day |
Last modified on
| 2023 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058761
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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