UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039641
Receipt number R000045207
Scientific Title Verification of imformed-consent using tablet app
Date of disclosure of the study information 2020/03/01
Last modified on 2020/02/28 19:51:07

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Basic information

Public title

Verification of imformed-consent using tablet app

Acronym

Tablet app for imformed-consent

Scientific Title

Verification of imformed-consent using tablet app

Scientific Title:Acronym

Tablet app for imformed-consent

Region

Japan


Condition

Condition

chronic kidney disease

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

verification of a newly developed tablet app (Dr.Visual, GONOSEN Inc. Tokyo) that provides medical information for CKD patients who are planned renal biopsy, blood access surgery, peritoneal dialysis catheter insertion, and peritoneal dialysis catheter removal.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

patients level of understanding with imformation

Key secondary outcomes

patients level of satisfaction with imformation


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

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

Other

Interventions/Control_1

control group: Explained in the traditional way using Imformed-Consent documents.

Interventions/Control_2

intervention group: Explained using new tablet app (Dr. Visual). The material is printed and a copy is given to the patient. Email delivery is also available . The original material will be scanned and stored on patients medical record.

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

20 years-old <=

Age-upper limit

100 years-old >

Gender

Male and Female

Key inclusion criteria

CKD patients who are planned renal biopsy, blood access surgery, peritoneal dialysis catheter insertion, and peritoneal dialysis catheter removal in Jikei University School of medicine hospital.

Key exclusion criteria

none

Target sample size

240


Research contact person

Name of lead principal investigator

1st name Takashi
Middle name
Last name Yokoo

Organization

The Jikei University School of Medicine

Division name

Nephrology and Hypertension

Zip code

105-8461

Address

3-25-8, Nishi-shimbashi, Minato-ku, Tokyo

TEL

0334331111

Email

tyokoo@jikei.ac.jp


Public contact

Name of contact person

1st name Nanae
Middle name
Last name Matsuo

Organization

The Jikei University School of Medicine

Division name

Nephrology and Hypertension

Zip code

105-8461

Address

3-25-8, Nishi-shimbashi, Minato-ku, Tokyo

TEL

0334331111

Homepage URL


Email

nana77m@jikei.ac.jp


Sponsor or person

Institute

Division of Nephrology and Hypertension, department of internal medicine, Nephrology and Hypertension

Institute

Department

Personal name



Funding Source

Organization

Division of Nephrology and Hypertension, department of internal medicine, Nephrology and Hypertension

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Clinical Research Support Center, The JIkei University School of Medicine

Address

3-25-8, Nishi-shimbashi, Minato-ku, Tokyo

Tel

0334331111

Email

clresuce@jikei.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

2020 Year 03 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

Preinitiation

Date of protocol fixation

2020 Year 01 Month 17 Day

Date of IRB

2020 Year 02 Month 10 Day

Anticipated trial start date

2020 Year 04 Month 01 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 02 Month 28 Day

Last modified on

2020 Year 02 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045207


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name