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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028665
Receipt No. 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

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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
Email 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
Email sakurada@marianna-u.ac.jp

Sponsor
Institute St. Marianna University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032813

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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