UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045661 |
|---|---|
| Receipt number | R000051526 |
| Scientific Title | Development of an e-learning-based educational program for nurses on nursing care of hemodialysis patients |
| Date of disclosure of the study information | 2021/10/15 |
| Last modified on | 2021/10/04 21:37:15 |
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Basic information
Public title
Development of an e-learning-based educational program for nurses on nursing care of hemodialysis patients
Acronym
Development of an e-learning-based educational program for nurses on nursing care of hemodialysis patients
Scientific Title
Development of an e-learning-based educational program for nurses on nursing care of hemodialysis patients
Scientific Title:Acronym
Development of an e-learning-based educational program for nurses on nursing care of hemodialysis patients
Region
| Japan |
Condition
Condition
hemodialysis
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop an e-learning program on professional knowledge and skills required by nurses to care for hemodialysis patients, and to conduct a process evaluation of the e-learning program by conducting a RCT (quasi-randomized controlled trial) study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The intervention group and the waiting group will be given a confirmation test and a questionnaire on confidence in nursing skills, and the change in scores before and after the program will be compared.
Key secondary outcomes
Conduct a process evaluation by conducting a questionnaire survey about the e-learning program.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Intervention group:
After taking the pre-test and answering the questionnaire on confidence in nursing practice, the participants will take the e-learning program within 2 weeks, and after taking the program, they will take the confirmation test, process evaluation questionnaire, and answer the questionnaire on confidence in nursing practice. After another two weeks, they will take the confirmation test again.
Interventions/Control_2
Waiting group:
After answering the pre-test and the questionnaire on confidence in nursing practice, the participants will take the confirmation test within 2 weeks, and then take the e-learning program within 2 weeks, and after taking the program, they will take the confirmation test, process evaluation questionnaire, and answer the questionnaire on confidence in nursing practice.
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
Nurses and assistant nurses who work at Hospital A and have no experience working in a dialysis unit
Key exclusion criteria
Nurses and assistant nurses who work at Hospital A and have experience working in a dialysis unit
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Naoko, Taisuke |
| Middle name | |
| Last name | Hashimoto, Togari |
Organization
The Open University of Japan
Division name
Life and Health Science Program, Graduate School of Cultural Studies, The Open University of Japan
Zip code
261-8586
Address
2 Chome-11 Wakaba, Mihama Ward, Chiba
TEL
043-276-5111
1928001990@campus.ouj.ac.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Hashimoto |
Organization
The Open University of Japan
Division name
Life and Health Science Program, Graduate School of Cultural Studies, The Open University of Japan
Zip code
261-8586
Address
2 Chome-11 Wakaba, Mihama Ward, Chiba
TEL
043-276-5111
Homepage URL
1928001990@campus.ouj.ac.jp
Sponsor or person
Institute
Life and Health Science Program, Graduate School of Cultural Studies, The Open University of Japan
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Open University of Japan
Address
2 Chome-11 Wakaba, Mihama Ward, Chiba
Tel
043-276-5111
rinrishinsa@ouj.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
| 2021 | Year | 10 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 02 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 09 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 04 | Day |
Last modified on
| 2021 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051526
