UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049411 |
|---|---|
| Receipt number | R000056222 |
| Scientific Title | Development of digital recording systems to evaluate the necessity and the appropriate selection of public health nursing practices |
| Date of disclosure of the study information | 2022/12/01 |
| Last modified on | 2024/11/05 08:37:53 |
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Basic information
Public title
Development of digital recording systems to evaluate the necessity and the appropriate selection of public health nursing practices
Acronym
Development of digital recording systems to evaluate the necessity and the appropriate selection of public health nursing practices
Scientific Title
Development of digital recording systems to evaluate the necessity and the appropriate selection of public health nursing practices
Scientific Title:Acronym
Development of digital recording systems to evaluate the necessity and the appropriate selection of public health nursing practices
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the item validity of the public health nurses' activity record
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Necessity of public health nurse activities
Key secondary outcomes
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
supervisory public health nurses
mid-career public health nurses
Key exclusion criteria
Those who have already responded to the pilot survey
Target sample size
1000
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
Hongo7-3-1 Bunkyo-ku, Tokyo, Japan
TEL
03-5841-3597
kyokoy-tky@g.ecc.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
| 2022 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.researchprotocols.org/2023/1/e45342/
Publication of results
Partially published
Result
URL related to results and publications
https://mhlw-grants.niph.go.jp/project/166018
Number of participants that the trial has enrolled
459
Results
The number of municipalities (number of public health nurses) that responded to the nationwide survey was 177 (184) for supervisory public health nurses and 196 (275) for mid-career public health nurses.
Mental health and maternal and child health were among the target areas of individual support with a high level of need for support answered by mid-career public health nurses.
Results date posted
| 2024 | Year | 05 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The number of valid responses regarding individual care was 275 (4.8%). The majority of the respondents were female (n=248, 90.2%), 133 (48.4%) were in their 30s, and 97 (35.3%) were in their 40s. The most common position was that of chief director (n=178, 64.7%).
Participant flow
The nationwide survey will be conducted using a web-based form, and a URL or QR code for the survey will be distributed to supervisory and midcareer PHNs. We will ask the research participants to (1) select one highly necessary and one less necessary element of individual care, community-based activities, and project development that they have performed within the last month; and (2) enter select cases into our system and summarize them. The level of necessity of each activity will be measured using a 10-point Likert scale from 1 (very unnecessary) to 10 (highly necessary). Additionally, we will ask participants about the importance and incomprehensibility of each item and whether to include any additional items. Responses will be sent directly to the researcher (ie, they will not go through the supervisory PHNs).
Adverse events
No adverse events occurred.
Outcome measures
Assessment items and characteristics for the selected cases
Level of nursing need for each case (10-point Likert scale)
Importance and difficulty in understanding each item
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | 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 | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Municipal public health nurses will be asked to fill in the activity record items and enter their subjective level of need for the cases with high and low necessity among (1) individual support, (2) district activities, and (3) projects for which they are in charge. The importance and readability of each item will also be investigated.
Management information
Registered date
| 2022 | Year | 11 | Month | 02 | Day |
Last modified on
| 2024 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056222
