UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047331 |
|---|---|
| Receipt number | R000053981 |
| Scientific Title | Shared decision making on dialysis modality selection in Japan: a cross-sectional study |
| Date of disclosure of the study information | 2022/03/30 |
| Last modified on | 2024/08/21 10:38:23 |
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Basic information
Public title
Shared decision making on dialysis modality selection in Japan: a cross-sectional study
Acronym
Shared decision making on dialysis modality selection in Japan: a cross-sectional study
Scientific Title
Shared decision making on dialysis modality selection in Japan: a cross-sectional study
Scientific Title:Acronym
Shared decision making on dialysis modality selection in Japan: a cross-sectional study
Region
| Japan |
Condition
Condition
Chronic Kidney Disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to determine the degree of shared decision making and decision conflict among dialysis patients and physician in Japan.
Basic objectives2
Others
Basic objectives -Others
To improve the quality of care of chronic kidney disease
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Shared decision making questionnaire, Decision Conflict Scale
Key secondary outcomes
1)Relationship between above mentioned score
2) Relationship between Shared decision making score for patient and physician
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult over age of 18, who understand written Japanese.
Patients who newly started dialysis therapy, or Nephrologist who supported patients' decision making.
Key exclusion criteria
Those who do not meet inclusion criteria
Target sample size
720
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Komatsu |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Healthcare Quality and Safety
Zip code
371-8511
Address
3-39-22 Showamachi, Maebashi, Gunma Prefecture
TEL
027-220-8767
komayasu@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Komatsu |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Healthcare Quality and Safety
Zip code
371-8511
Address
3-39-22 Showamachi, Maebashi, Gunma Prefecture
TEL
027-220-8767
Homepage URL
komayasu@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Baxter Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Ethical Review Board for Medical Research Involving Human Subjects
Address
3-39-22 Showamachi, Maebashi, Gunma Prefecture
Tel
027-220-8740
hitotaisho-ciru@ml.gunma-u.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
| 2022 | Year | 03 | Month | 30 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study using survey questionnaire
Management information
Registered date
| 2022 | Year | 03 | Month | 30 | Day |
Last modified on
| 2024 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053981
