UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046041 |
|---|---|
| Receipt number | R000052550 |
| Scientific Title | Nationwide retrospective cohort study for Miawase approach to maintenance dialysis |
| Date of disclosure of the study information | 2022/07/01 |
| Last modified on | 2022/04/30 12:27:38 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Nationwide survey for Miawase approach to dialysis
Acronym
Nationwide survey for Miawase approach to dialysis
Scientific Title
Nationwide retrospective cohort study for Miawase approach to maintenance dialysis
Scientific Title:Acronym
Nationwide retrospective cohort study for Miawase approach to maintenance dialysis
Region
| Japan |
Condition
Condition
Maintenance dialysis patients who died after forgoing dialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the compliance of dialysis facilities nationwide with the 2020 recommendations on shared decision for the initiation and continuation of dialysis from the Japanese Society for dialysis Therapy, implementation status of advance care planning and shared decision making, and the actual status of Miawase approach to dialysis.
Basic objectives2
Others
Basic objectives -Others
To determine whether the person completing the statistical survey of of Japanese Society for Dialysis Therapy selects refusal of treatment, withholding of treatment, or complications (heart failure, uremia, etc.) as the cause of death in cases of Miawase approach to dialysis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Mortality due to discontinuation of dialysis per year 2. Selection on cause of death for patients dying from discontinuation of dialysis
Key secondary outcomes
1. The compliance of shared decision for the initiation and continuation of dialysis from the Japanese Society for dialysis Therapy 2. Implementation status of advance care planning 3. Implementation status of shared decision making 4. The actual status of Miawase approach to dialysis
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who died from January 1, 2021 to December 31, 2021 after forgoing dialysis
Key exclusion criteria
Nothing
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Okada |
Organization
Social medical corporation Kawashimakai
Division name
Blood purification management center
Zip code
770-0011
Address
6-1 Kitasako ichiban-cho, Tokushima-shi, Tokushima,Japan
TEL
088-631-0110
kokada@minos.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Sasaka |
Organization
Social medical corporation Kawashimakai, Kawashima hospital
Division name
General affair section
Zip code
770-0011
Address
6-1 Kitasako ichiban-cho, Tokushima-shi, Tokushima,Japan
TEL
088-631-0110
Homepage URL
sasaka@khg.or.jp
Sponsor or person
Institute
The 66th Annual Meeting of the Japanese Society for Dialysis Therapy
Institute
Department
Personal name
Funding Source
Organization
The 66th Annual Meeting of the Japanese Society for Dialysis Therapy
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawashima hospital, Research Ethics Review Committee
Address
6-1 Kitasako ichiban-cho, Tokushima-shi, Tokushima, Japan
Tel
088-631-0110
sasaka@khg.or.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 | 07 | Month | 01 | 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
Completed
Date of protocol fixation
| 2021 | Year | 10 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing
Management information
Registered date
| 2021 | Year | 11 | Month | 11 | Day |
Last modified on
| 2022 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052550
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
