UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058543 |
|---|---|
| Receipt number | R000066942 |
| Scientific Title | Conducting randomized controlled trials in the evaluation of a program to support visiting nurses' competency development in making clinical judgments when responding to emergency telephone calls |
| Date of disclosure of the study information | 2025/07/22 |
| Last modified on | 2025/07/22 11:14:23 |
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Basic information
Public title
Conducting randomized controlled trials in the evaluation of a program to support visiting nurses' competency development in making clinical judgments when responding to emergency telephone calls
Acronym
Conducting randomized controlled trials in the evaluation of a program to support visiting nurses' competency development in making clinical judgments when responding to emergency telephone calls
Scientific Title
Conducting randomized controlled trials in the evaluation of a program to support visiting nurses' competency development in making clinical judgments when responding to emergency telephone calls
Scientific Title:Acronym
Conducting randomized controlled trials in the evaluation of a program to support visiting nurses' competency development in making clinical judgments when responding to emergency telephone calls
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Implement a program to support visiting nurses' competency development in making clinical judgments when responding to emergency telephone calls, and evaluate it through a randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Responses to the Japanese version of the Lasater Clinical Judgment Rubric two months after program implementation.
Key secondary outcomes
Responses to the Kuroda Intrinsic Intuition Scale and the scale to assess the critical thinking of clinical nurses two months after program implementation.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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
The intervention group will participate in the Program to Support Visiting Nurses' Competency Development in Making Clinical Judgments when Responding to Emergency Telephone Calls (two sessions, two hours each).
Interventions/Control_2
The control group will not undergo the intervention.
Only those who wish to participate will undergo the Program to Support Visiting Nurses' Competency Development in Making Clinical Judgments when Responding to Emergency Telephone Calls.
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
Inclusion criteria will be selected based on the following criteria 1 to 4.
1. Employed at a visiting nursing station and not holding a managerial or supervisory position.
2. Less than six years of experience in visiting nursing.
3. Currently responsible for responding to emergency calls.
4. Able to obtain research consent.
Key exclusion criteria
Exclusion criteria are any of the following 1 to 5.
1. Not working at a visiting nursing station.
2. Holding a managerial or senior position at a visiting nursing station.
3. Having more than 6 years of experience in visiting nursing.
4. Not being responsible for emergency telephone calls at a visiting nursing station.
5. Unable to obtain consent for research.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yasuko |
| Middle name | |
| Last name | Hosoda |
Organization
Osaka Metropolitan University
Division name
Graduate School of Nursing
Zip code
545-0051
Address
1-5-17 Asahimachi, Abeno-ku, Osaka
TEL
06-6645-3511
hosoday@omu.ac.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Tanaka |
Organization
Osaka Metropolitan University
Division name
Graduate School of Nursing, Doctoral Programs in Nursing Science
Zip code
545-0051
Address
1-5-17 Asahimachi, Abeno-ku, Osaka
TEL
06-6645-3511
Homepage URL
tanaka-y@kawasaki-cn.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University
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
Other related organizations
Co-sponsor
Name of secondary funder(s)
Kawasaki City College of Nursing
IRB Contact (For public release)
Organization
Osaka Metropolitan University
Address
1-5-17 Asahimachi, Abeno-ku, Osaka
Tel
06-6645-3511
gr-hab-rinri@omu.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
| 2025 | Year | 07 | Month | 22 | 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
80
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
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 12 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 22 | Day |
Last modified on
| 2025 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066942
