UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014507
Receipt number 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 09:48:44

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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