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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018136
Receipt No. 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

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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/ctr_e/ctr_view.cgi?recptno=R000021005

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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