UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063611 |
|---|---|
| Receipt number | R000072775 |
| Scientific Title | Effect of an Educational Program on Nurses' Shared Decision-Making Competence in Renal Replacement Therapy Decision Support |
| Date of disclosure of the study information | 2026/11/13 |
| Last modified on | 2026/11/11 21:03:21 |
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Basic information
Public title
Effect of an Educational Program on Nurses' Shared Decision-Making Competence in Renal Replacement Therapy Decision Support
Acronym
Effect of an Educational Program on Nurses' Shared Decision-Making Competence in Renal Replacement Therapy Decision Support
Scientific Title
Effect of an Educational Program on Nurses' Shared Decision-Making Competence in Renal Replacement Therapy Decision Support
Scientific Title:Acronym
Effect of an Educational Program on Nurses' Shared Decision-Making Competence in Renal Replacement Therapy Decision Support
Region
| Japan |
Condition
Condition
Chronic Kidney Disease
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a shared decision-making educational program for nurses involved in renal replacement therapy decision support and evaluate its effectiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Shared decision-making competence (Japanese version of the SDM-C scale)
(Baseline, 1 month after intervention, 3 months after intervention)
Key secondary outcomes
Knowledge of shared decision-making
Knowledge of renal replacement therapy
Communication skills (ENDCOREs)
Interprofessional collaboration (AITCS-II-J)
(Baseline, 1 month after intervention, 3 months after intervention)
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
| Behavior,custom |
Interventions/Control_1
Intervention: SDM educational program
1. Viewing on-demand lectures
2. Participation in role-playing exercises
3. Participation in a follow-up session
Interventions/Control_2
No SDM educational program
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. Nurses working in nephrology departments (e.g., inpatient wards, outpatient clinics, or dialysis units) at healthcare institutions that have registered to provide renal replacement therapy guidance and management services under the Japanese medical reimbursement system.
2. Nurses who have received an explanation of the study and voluntarily provided informed consent to participate.
3. Nurses who have access to the internet and are able to view on-demand educational materials and complete web-based questionnaires.
Key exclusion criteria
1. Nurses who are scheduled to transfer, retire, or take extended leave during the study period, making it difficult to complete the 3-month follow-up.
2. Nurses with less than one year of experience in nephrology departments (e.g., inpatient wards, outpatient clinics, or dialysis units).
3. Nurses who have not been involved in renal replacement therapy decision support within the past four years.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | misa |
| Middle name | |
| Last name | iida |
Organization
Nagoya City University
Division name
Graduate School of Nursing
Zip code
4678601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku Nagoya
TEL
052-853-8841
iidamisa@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | misa |
| Middle name | |
| Last name | iida |
Organization
Nagoya City University
Division name
Graduate School of Nursing
Zip code
4678601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku Nagoya
TEL
052-853-8037
Homepage URL
iidamisa@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City 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
Shinshu University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City University Graduate School of Nursing Research Ethics Committee
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku Nagoya
Tel
052-853-8037
iidamisa@med.nagoya-cu.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
| 2026 | Year | 11 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 11 | Month | 02 | Day |
Date of IRB
| 2026 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 11 | Month | 12 | Day |
Last modified on
| 2026 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072775
