UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033719
Receipt number R000038448
Scientific Title Pilot study of educational program based on IMCHB for people with diabetic nephropathy
Date of disclosure of the study information 2018/09/01
Last modified on 2019/08/29 19:19:35

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Basic information

Public title

Pilot study of educational program based on IMCHB for people with diabetic nephropathy

Acronym

Pilot study of educational program based on IMCHB for people with diabetic nephropathy

Scientific Title

Pilot study of educational program based on IMCHB for people with diabetic nephropathy

Scientific Title:Acronym

Pilot study of educational program based on IMCHB for people with diabetic nephropathy

Region

Japan


Condition

Condition

diabetic nephropathy

Classification by specialty

Endocrinology and Metabolism Nephrology Nursing
Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this research is to confirm the effect and correction points of the educational program for dialysis prevention of diabetic nephropathy patients developed based on the Interaction Model of Client Health Behavior (IMCHB) by a pilot study.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

eGFR at the end of the educational program

Key secondary outcomes

HbA1c at the end of the educational program, blood pressure, self-efficacy, mastery of knowledge necessary to prevent the progress of diabetic nephropathy


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

Interventions/Control_1

A total of 6 times (one intervention time is around 30 minutes) on the same day as outpatient visit examination day, do Diabetes Dialysis Preventive Outpatient Program.

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Outpatients (HbA1c (NGSP value) of 6.5% or more, nephropathy 2 or more) who recognized doctors needing patient education for diabetes dialysis prevention

Key exclusion criteria

People with vision disorders such as severe diabetic retinopathy
People with dementia

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Michiyo
Middle name
Last name Oka

Organization

Gunma University

Division name

Graduate School of Health Sciences

Zip code

371-8514

Address

3-39-22 Showa-machi, Maebashi, Gunma, 371-8514 Japan

TEL

027-220-8926

Email

michiyooka@gunma-u.ac.jp


Public contact

Name of contact person

1st name Michiyo
Middle name
Last name Oka

Organization

Gunma University

Division name

Graduate School of Health Sciences

Zip code

371-8514

Address

3-39-22 Showa-machi, Maebashi, Gunma, 371-8514 Japan

TEL

027-220-8926

Homepage URL


Email

michiyooka@gunma-u.ac.jp


Sponsor or person

Institute

Gunma University

Institute

Department

Personal name



Funding Source

Organization

Self funding

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

Gunma University Ethical Review Board for Medical Research Involving Human Subjects

Address

3-39-15 Showa-machi, Maebashi, Gunma, 371-8514 Japan

Tel

027-220-8740

Email

hitotaisho-ciru@ml.gunma-u.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

2018 Year 09 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

Enrolling by invitation

Date of protocol fixation

2018 Year 07 Month 10 Day

Date of IRB

2018 Year 07 Month 26 Day

Anticipated trial start date

2018 Year 09 Month 01 Day

Last follow-up date

2023 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

2018 Year 08 Month 10 Day

Last modified on

2019 Year 08 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038448


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name