UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028665 |
|---|---|
| Receipt number | R000032813 |
| Scientific Title | Changes in QOL of patients with end stage renal failure and their families after initiation of peritoneal dialysis |
| Date of disclosure of the study information | 2017/08/16 |
| Last modified on | 2017/08/15 11:29:41 |
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Basic information
Public title
Changes in QOL of patients with end stage renal failure and their families after initiation of peritoneal dialysis
Acronym
PDQOL study
Scientific Title
Changes in QOL of patients with end stage renal failure and their families after initiation of peritoneal dialysis
Scientific Title:Acronym
PDQOL study
Region
| Japan |
Condition
Condition
end stage renal failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate changes in QOL of patients and their families before initiation of peritoneal dialysis to one year after
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of QOL of patients with end stage renal failure and their families before and after initiation of peritoneal dialysis
Key secondary outcomes
Factors related to QOL of peritoneal dialysis patients and their families
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
End stage renal failure patients, going to introduce peritoneal dialysis at St. Marianna Hospital or other institution at 65 years old or older, and their families
Key exclusion criteria
The patients scheduled foe kidney transplantation by one year.
The patients judged inappropriate by a doctor.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsutomu Sakurada |
Organization
St. Marianna University
Division name
Division of Nephrology and Hypertension
Zip code
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki-city, Kanagawa, Japan
TEL
044-977-8111
sakurda@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsutomu Sakurada |
Organization
St. Marianna University
Division name
Division of Nephrology and Hypertension
Zip code
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki-city, Kanagawa, Japan
TEL
044-977-8111
Homepage URL
sakurada@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
| 2017 | Year | 08 | Month | 16 | 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
| 2015 | Year | 04 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is Multicenter Collaborative Prospective Registration Research.
We studied end stage renal failure patients, going to initiate peritoneal dialysis at 65 years old or older, and their families.
We register them from 4 Feb. 2016 to 31 Mar. 2019.
Management information
Registered date
| 2017 | Year | 08 | Month | 15 | Day |
Last modified on
| 2017 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032813
