UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051083 |
|---|---|
| Receipt number | R000058255 |
| Scientific Title | Effectiveness of an Educational Program for Japanese Nurses to Work with Foreign Nurses: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2023/05/18 |
| Last modified on | 2024/05/27 19:30:21 |
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Basic information
Public title
Effectiveness of an Educational Program for Japanese Nurses to Work with Foreign Nurses: A Randomized Controlled Trial
Acronym
Effectiveness of an Educational Program for Japanese Nurses to Work with Foreign Nurses: A Randomized Controlled Trial
Scientific Title
Effectiveness of an Educational Program for Japanese Nurses to Work with Foreign Nurses: A Randomized Controlled Trial
Scientific Title:Acronym
Effectiveness of an Educational Program for Japanese Nurses to Work with Foreign Nurses: A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of educational programs for Japanese nurses to work with foreign nurses
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Knowledge, attitude, confidence, and skill scores on follow-up test
Key secondary outcomes
Knowledge, attitude, confidence, and skill scores on post test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Educational Program for Japanese Nurses to Work with Foreign Nurse. 85 minutes of prior learning using e-learning and 150 minutes of online workshop.
Interventions/Control_2
Nothing
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
1) Japanese as a first language
2) Those who have obtained a nursing license in Japan
3) Those who have received nursing education in Japan
4) Those who wish to participate in this program
Key exclusion criteria
Nothing
Target sample size
96
Research contact person
Name of lead principal investigator
| 1st name | Rina |
| Middle name | |
| Last name | Shoki |
Organization
St Lukes International University
Division name
Graduate School of Nursing Science
Zip code
104-0044
Address
10-1 Akashi-cho, Chuo-ku, Tokyo
TEL
080-6612-7757
21dn006@slcn.ac.jp
Public contact
Name of contact person
| 1st name | Rina |
| Middle name | |
| Last name | Shoki |
Organization
St Lukes International University
Division name
Global Health Nursing, Graduate School of Nursing Science
Zip code
104-0044
Address
10-1 Akashi-cho, Chuo-ku, Tokyo
TEL
080-6612-7757
Homepage URL
21dn006@slcn.ac.jp
Sponsor or person
Institute
St Lukes International University
Institute
Department
Personal name
Funding Source
Organization
Fumiko Yamaji Fund for Professional Nursing Education and Research
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St Lukes International University Research Ethics Review Committee
Address
10-1 Akashi-cho, Chuo-ku, Tokyo
Tel
03-5550-2423
kenkyukikaku@luke.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 | 05 | Month | 18 | 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
120
Results
For the intervention group the mean change from pre-test to post-test, significantly increased for knowledge (p =< .001), skills (p = 0.001), and confidence (p =< .001) scores, but there was no significant difference in attitude score (p = 0.15). Likewise, for the mean change from pre-test to follow-up test, the intervention group significantly increased their attitude (p = <.001), knowledge (p = < .001), skills (p = 0.008) and confidence (p = < .001).
Results date posted
| 2024 | Year | 05 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean number of years of nursing experience was 11.2 years in the intervention group and 12.2 years in the control group. Regarding experience working with foreign nurses, 13 (21.7%) in the intervention group and 21.7% in the control group in both groups were currently working together, and 7 (11.7%) in the intervention group and 8 (13.3%) in the control group had worked with them in the past. Eleven (18.3%) of the intervention group and 16 (26.7%) of the control group had taught foreign nurses, and 14 (23.3%) of the intervention group and 15 (25.0%) of the control group had lived abroad.
Participant flow
Through random assignment using the minimization method, 120 participants were assigned to the intervention and control groups.
Two of the intervention group participants did not attend the workshop and did not respond to the pre-test and beyond. One participant in the control group did not respond to the post-test and two did not respond to the follow-up test. No participants withdrew their consent to participate in the study.
Adverse events
No adverse event
Outcome measures
Change in attitude, knowledge, skills, and confidence scores in the follow-up test from the pre-test
Change in attitude, knowledge, skills, and confidence scores in the post-test from the pre-test
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 05 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 03 | 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
| 2023 | Year | 05 | Month | 17 | Day |
Last modified on
| 2024 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058255
