UMIN-CTR Clinical Trial

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
Email	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
Email	soeda@sfc.keio.ac.jp

Sponsor
Institute	Keio University Faculty of Nursing and Medical Care
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021005