UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032971 |
|---|---|
| Receipt number | R000037572 |
| Scientific Title | Development of guidelines for Public Health Nurses working for communities with special attention on community characteristics - the development of tool "Community Chart" for effective activities and the evaluation of the tool- |
| Date of disclosure of the study information | 2018/06/15 |
| Last modified on | 2019/06/13 10:49:20 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development of guidelines for Public Health Nurses working for communities with special attention on community characteristics - the development of tool "Community Chart" for effective activities and the evaluation of the tool-
Acronym
Development and evaluation of the tool for Public Health Nurses working for community
Scientific Title
Development of guidelines for Public Health Nurses working for communities with special attention on community characteristics - the development of tool "Community Chart" for effective activities and the evaluation of the tool-
Scientific Title:Acronym
Development and evaluation of the tool for Public Health Nurses working for community
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Nursing | Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of the tool "Community Chart" for Public Health Nurses through actual usage of the tool by Public Health Nurses and to revise the tool by assessing the outcome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Public Health Nurses' recognition regarding their own activities (before intervention, after 3 months, after 6 months
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Full-time Public Health Nurses working for a local government and being in charge of a community.
Interventions/Control_2
Public Health Nurses will not join the training program. They will not utilize the tool. They continue to conduct usual Public Health activities.
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
Full-time Public Health Nurses working for a local government and being in charge of a community.
Key exclusion criteria
Public Health Nurses who are not eligible to the key inclusion criteria
Target sample size
125
Research contact person
Name of lead principal investigator
| 1st name | Kiyomi |
| Middle name | |
| Last name | ASAHARA |
Organization
St.Luke's International University
Division name
Graduate School of Nursing Science
Zip code
104-0044
Address
10-1, Akashi-cho, Chuo-ku, TOKYO
TEL
03-3543-6391
asahara@slcn.ac.jp
Public contact
Name of contact person
| 1st name | Maasa |
| Middle name | |
| Last name | KOBAYASHI |
Organization
St.Luke's International University
Division name
Graduate School of Nursing Science
Zip code
104-0044
Address
10-1, Akashi-cho, Chuo-ku, TOKYO
TEL
03-3543-6391
Homepage URL
maasa-kobayashi@slcn.ac.jp
Sponsor or person
Institute
St. Luke's International University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor 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
St.Luke's International University
Address
10-1, Akashi-cho, Chuo-ku, TOKYO
Tel
03-3543-6391
maasa-kobayashi@slcn.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
| 2018 | Year | 06 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
105
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
Completed
Date of protocol fixation
| 2018 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 05 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 13 | Day |
Last modified on
| 2019 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037572
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
