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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014507
Receipt No. R000016804
Scientific Title Effect of an educational program by a transplant physician and a transplant recipient on attitudes towards deceased organ donation among Japanese nursing students: Randomized controlled trial
Date of disclosure of the study information 2014/08/01
Last modified on 2014/11/19

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Basic information
Public title Effect of an educational program by a transplant physician and a transplant recipient on attitudes towards deceased organ donation among Japanese nursing students: Randomized controlled trial
Acronym Effect of an educational program on attitudes towards deceased organ donation
Scientific Title Effect of an educational program by a transplant physician and a transplant recipient on attitudes towards deceased organ donation among Japanese nursing students: Randomized controlled trial
Scientific Title:Acronym Effect of an educational program on attitudes towards deceased organ donation
Region
Japan

Condition
Condition healthy individuals
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess whether or not a systematic educational program on ESKD, deceased organ donation, and transplantation provided by a transplant physician and a transplant recipient increases the number of organ donation sign-ups among Japanese nursing students compared with distribution of information booklets alone
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes commitment to deceased organ donation by signing a donor card (22 days later after the intervention)
Key secondary outcomes willingness to sign a donor card (22 days later after the intervention)
family's signature on the donor card signed by students
family's commitment for deceased organ donation by signing a donor card
change in knowledge about deceased organ donation and transplantation
willingness to donate organs after brain death
willingness to donate organs after cardiac death
willingness to donate a deceased family member's organs when a family member indicates willingness to donate organs
willingness to donate a deceased family member's organs when willingness of a family member is not known
discussion with their family about deceased organ donation

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 a classroom lecture by a transplant physician and a kidney transplant recipient about ESKD, kidney replacement therapy, deceased organ donation, and transplantation (90 min)
a small group discussion about deceased organ donation and transplantation (90 min)
a brief information booklet about deceased organ donation and transplantation
Interventions/Control_2 a brief information booklet about deceased organ donation and transplantation
a detail information booklet about deceased organ donation and transplantation
an information booklet about ESKD
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria nursing students who do not have a signed donor card
Key exclusion criteria nursing students who are absent for the initial questionnaire survey or withhold consent
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shunichi Fukuhara
Organization School of Public Health in the Graduate School of Medicine, Kyoto University
Division name Department of Healthcare Epidemiology
Zip code
Address Yoshida Konoemachi, Sakyo-ku, Kyoto, 606 8501, Japan
TEL 075-753-4646
Email fukuhara.shunichi.6m@kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Minoru Murakami
Organization School of Public Health in the Graduate School of Medicine, Kyoto University
Division name Department of Healthcare Epidemiology
Zip code
Address Yoshida Konoemachi, Sakyo-ku, Kyoto, 606 8501, Japan
TEL 075-753-4646
Homepage URL
Email murakami11108510@yahoo.co.jp

Sponsor
Institute Department of Healthcare Epidemiology, School of Public Health in the Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization Saku Central Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Nephrology, Saku Central Hospital
Saku Central Hospital Nursing School
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 佐久総合病院看護専門学校(長野県)

Other administrative information
Date of disclosure of the study information
2014 Year 08 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
2014 Year 07 Month 07 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 25 Day
Last follow-up date
2014 Year 10 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 07 Month 08 Day
Last modified on
2014 Year 11 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016804

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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