UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038170 |
|---|---|
| Receipt number | R000042986 |
| Scientific Title | Study on post-dialysis fatigue in home hemodialysis patents |
| Date of disclosure of the study information | 2019/10/15 |
| Last modified on | 2020/01/09 15:06:54 |
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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
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/
atsuji@fukekai.com
Sponsor or person
Institute
Fuke Home Medical Rehabilitation Care Center
Medical division
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042986
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
