UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038460 |
|---|---|
| Receipt number | R000043828 |
| Scientific Title | Establishment of interactive communication system in home medical care for peritoneal dialysis patients |
| Date of disclosure of the study information | 2019/11/01 |
| Last modified on | 2023/06/08 14:22:22 |
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Basic information
Public title
Establishment of interactive communication system in home medical care for peritoneal dialysis patients
Acronym
Establishment of interactive communication system in home medical care for peritoneal dialysis patients
Scientific Title
Establishment of interactive communication system in home medical care for peritoneal dialysis patients
Scientific Title:Acronym
Establishment of interactive communication system in home medical care for peritoneal dialysis patients
Region
| Japan |
Condition
Condition
chronic renal failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The need for regional collaboration in the treatment of peritoneal dialysis patients is obvious in Japan, which is facing an aging society. Participation such as visiting medical care and visiting nursing that are unfamiliar with peritoneal dialysis is inevitable for the regional cooperation. Under such circumstances, instead of the traditional collaboration with visiting nursing instructions and reports, we established a system that allows constant contact with the visiting nursing station 24 hours a day, 365 days a year. The purpose of this study is to strengthen regional collaboration and improve peritoneal dialysis practice. The outcome of this study is an assessment of the incidence of peritonitis, exit / tunnel infection, and heart failure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The outcome of this study is an assessment of the incidence of peritonitis, exit / tunnel infection, and heart failure.
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Uremia is controlled by peritoneal dialysis
2) No signs of fluid retention due to severe heart failure or lack of dialysis
3) Age is between 20 and 85
4) Understand the significance of home-visit nursing and introduce home-visit nursing
Key exclusion criteria
1) Does not meet the above selection criteria
2) Patients who are judged unsuitable for registration in this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yukinao |
| Middle name | |
| Last name | Sakai |
Organization
Nippon Medical School
Division name
Department of Nephrology
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
y-sakai@nms.ac.jp
Public contact
Name of contact person
| 1st name | Yukinao |
| Middle name | |
| Last name | Sakai |
Organization
Nippon Medical School
Division name
Department of Nephrology
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
Homepage URL
y-sakai@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
IKIIKI SUN Visiting Nursing Rehabilitation Station
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medical School Hospital Ethics Committee
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
Tel
03-3822-2131
nms_fuzokurinri@nms.ac.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
| 2019 | Year | 11 | 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
| 2019 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study analyzes changes in patients' quality of life, the incidence of peritonitis, the incidence of heart failure, and the frequency of hospitalization by introducing a constant contact system with a home-visit nursing station.
Management information
Registered date
| 2019 | Year | 11 | Month | 01 | Day |
Last modified on
| 2023 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043828
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
