UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058641 |
|---|---|
| Receipt number | R000067024 |
| Scientific Title | Implementation Study of a Collaborative Care Package Between a Core Hospital and Visiting Nurses for Home-Based Support of Peritoneal Dialysis Patients |
| Date of disclosure of the study information | 2025/07/30 |
| Last modified on | 2026/01/15 23:23:00 |
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Basic information
Public title
Implementation Study of a Collaborative Care Package Between a Core Hospital and Visiting Nurses for Home-Based Support of Peritoneal Dialysis Patients
Acronym
Nikko Peritoneal Dialysis Connect Study
Scientific Title
Implementation Study of a Collaborative Care Package Between a Core Hospital and Visiting Nurses for Home-Based Support of Peritoneal Dialysis Patients
Scientific Title:Acronym
Implementation Study of a Collaborative Care Package Between a Core Hospital and Visiting Nurses for Home-Based Support of Peritoneal Dialysis Patients
Region
| Japan |
Condition
Condition
Chronic kidney disease patients undergoing peritoneal dialysis therapy
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to implement a collaborative care package between a core hospital and visiting nurses in Nikko City, Tochigi Prefecture, Japan, in order to establish a home-based care support system for patients receiving peritoneal dialysis, and to evaluate its implementation outcomes. Implementation outcomes will be assessed using indicators such as the Organizational Readiness for Implementing Change (ORIC) score, as well as measures of acceptability, feasibility, and appropriateness, through a mixed-methods approach to achieve a comprehensive evaluation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Organizational Readiness for Implementing Change (ORIC) Scale among Visiting Nurses and Dialysis Nurses
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
An implementation program to strengthen collaboration between hospital dialysis nurses and visiting nurses, including
1. a training session on peritoneal dialysis nursing
2. joint home visits to PD patients
3. standardized nursing practice based on an observation checklist
4. information sharing via the Medical Care Station(MCS) platform
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Visiting Nurses
1) Nurses who are employed at a home-visit nursing station located in Nikko City, Tochigi Prefecture.
2) Nurses who may be involved in providing home-visit nursing care to peritoneal dialysis patients during the study period.
Key exclusion criteria
Those who are scheduled to take long-term leave or be transferred during the research period and are deemed unable to continue participating in the research.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | daisuke |
| Middle name | |
| Last name | mimura |
Organization
Dokkyo Medical University Nikko Medical Center
Division name
nursing department
Zip code
321-1298
Address
145-1 Moritomo, Nikko City, Tochigi Prefecture
TEL
0288-23-7000
mimura-d@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | daisuke |
| Middle name | |
| Last name | mimura |
Organization
Dokkyo Medical University Nikko Medical Center
Division name
nursing department
Zip code
321-1298
Address
145-1 Moritomo, Nikko City, Tochigi Prefecture
TEL
0288-23-7000
Homepage URL
mimura-d@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University Nikko Medical Center
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University Nikko Medical Center
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
Dokkyo Medical University Nikko Medical Center Life Ethics Committee
Address
145-1 Moritomo, Nikko City, Tochigi Prefecture
Tel
0288-23-7000
mimura-d@dokkyomed.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
| 2025 | Year | 07 | Month | 30 | 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
| 2025 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 29 | Day |
Last modified on
| 2026 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067024
