UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018136 |
|---|---|
| Receipt number | R000021005 |
| Scientific Title | Building self care system to support transitions for liver transplant children |
| Date of disclosure of the study information | 2015/06/30 |
| Last modified on | 2019/07/03 10:16:53 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Building self care system to support transitions for liver transplant children
Acronym
Building self care system for liver transplant children
Scientific Title
Building self care system to support transitions for liver transplant children
Scientific Title:Acronym
Building self care system for liver transplant children
Region
| Japan |
Condition
Condition
Pediatric Liver transplant recipients
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Pediatrics |
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to increase self care ability for children who recieved liver transplant through out-door educational activities.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
IKR Evaluation Sheet
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Outdoor Educational Activities
(2-3 days)
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
| 9 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1, 9 years of age or older
2, Out-patients who are in stable condition.
(No event of rejection/infection within 6 months.)
3, Both a patient and his/her legal guardian agree to participate this study
4, Insured
Key exclusion criteria
Patients who do not meet inclusion criteria 1-4.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Etsuko |
| Middle name | |
| Last name | Soeda |
Organization
Keio University
Division name
Faculty of Nursing and Medical Care
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-ku Tokyo Japan
TEL
03-5363-3341
soeda@sfc.keio.ac.jp
Public contact
Name of contact person
| 1st name | Etsuko |
| Middle name | |
| Last name | Soeda |
Organization
Keio University
Division name
Faculty of Nursing and Medical Care
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-ku Tokyo Japan
TEL
03-5363-3341
Homepage URL
soeda@sfc.keio.ac.jp
Sponsor or person
Institute
Keio University Faculty of Nursing and Medical Care
Institute
Department
Personal name
Funding Source
Organization
KAKENHI
Grant-in-Aid for Scientific Research
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
Ethics Committee, Keio University, School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
+81-3-3353-1211
med-bemoc-office@adst.keio.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
| 2015 | Year | 06 | 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
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 09 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 30 | Day |
Last modified on
| 2019 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021005
