UMIN-CTR Clinical Trial

Basic information
Public title	Study on post-dialysis fatigue in home hemodialysis patents
Acronym	Study on post-dialysis fatigue in home hemodialysis patents
Scientific Title	Study on post-dialysis fatigue in home hemodialysis patents
Scientific Title:Acronym	Study on post-dialysis fatigue in home hemodialysis patents
Region	Japan

Condition
Condition	Chronic kidney disease
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study, we investigated post-dialysis fatigue in home dialysis patients using the post-dialysis fatigue self-assessment scale to understand the factors affecting QOL.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The primary end point of this study is to compare post-dialysis fatigue in home hemodialysis and outpatient maintenance dialysis patients, and to clarify the current status of post-dialysis fatigue and the factors affecting QOL. PDF scale is performed 3 times a month from the first time.
Key secondary outcomes	Physical functioning, recovery time, fatigue scale, self-rated health, fatigue symptoms before dialysis, basic patient information (age, sex, dialysis history, past history), nutritional evaluation (serum Evaluate albumin concentration), dialysis efficiency (Kt / V), and changes in systolic blood pressure before and after 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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The PDF scale is implemented for 30 home hemodialysis patients residing in Fujimino medical home that has received written consent.
Key exclusion criteria	Hemodialysis patients are excluded from this study when they discontinue dialysis, transition to peritoneal dialysis, combined with peritoneal dialysis, or receive kidney transplantation.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Akira Middle name Last name Tsuji
Organization	Fuke Home Medical Rehabilitation Care Center
Division name	Medical division
Zip code	356-0051
Address	1839-4 Kamekubo, Fujimino Saitama, Japan
TEL	049-293-8222
Email	atsuji@fukekai.com

Public contact
Name of contact person	1st name Akira Middle name Last name Tsuji
Organization	Fuke Home Medical Rehabilitation Care Center
Division name	Medical division
Zip code	356-0051
Address	1839-4 Kamekubo, Fujimino Saitama, Japan
TEL	049-293-8222
Homepage URL	http://www.fuke-zaitaku.com/
Email	atsuji@fukekai.com

Sponsor
Institute	Fuke Home Medical Rehabilitation Care Center Medical division
Institute
Department

Funding Source
Organization	Fuke hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethical Committee of Fuke hospital
Address	2197 Kamekubo, Fujimino Saitama, Japan
Tel	049-264-8811
Email	t-futaesaku@fukekai.com

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	富家在宅リハビリテーションケアセンター / Fuke Home Medical Rehabilitation Care Center

Other administrative information
Date of disclosure of the study information	2019 Year 10 Month 15 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	Enrolling by invitation
Date of protocol fixation	2019 Year 09 Month 15 Day
Date of IRB	2020 Year 09 Month 30 Day
Anticipated trial start date	2019 Year 10 Month 15 Day
Last follow-up date	2021 Year 10 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

This is an observational study of cases. The subject is a dialysis patient occupying the Fujimino medical home from Octorber 2019 to September 2020. PDF scale is performed 3 times a month from the first time. Physical function, recovery time, fatigue scale, self-rated health, fatigue symptoms before dialysis, basic patient information (age, gender, dialysis history, past history), nutritional evaluation (serum albumin concentration), Evaluate changes in dialysis efficiency and systolic blood pressure before and after dialysis.

Management information
Registered date	2019 Year 10 Month 01 Day
Last modified on	2020 Year 01 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042986