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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002186
Receipt No. R000002663
Scientific Title Japan Diabetes Outcome Intervention Trial 2 (J-DOIT2) The large trial to improve the medical care of the family doctors for type 2 diabetes patients and to decrease dropout rate of these patients.
Date of disclosure of the study information 2009/07/13
Last modified on 2012/01/14

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Basic information
Public title Japan Diabetes Outcome Intervention Trial 2 (J-DOIT2)
The large trial to improve the medical care of the family doctors for type 2 diabetes patients and to decrease dropout rate of these patients.
Acronym Japan Diabetes Outcome Intervention Trial 2 (J-DOIT2)
Scientific Title Japan Diabetes Outcome Intervention Trial 2 (J-DOIT2)
The large trial to improve the medical care of the family doctors for type 2 diabetes patients and to decrease dropout rate of these patients.
Scientific Title:Acronym Japan Diabetes Outcome Intervention Trial 2 (J-DOIT2)
Region
Japan

Condition
Condition Type 2 Diabetes Mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We carry out "diabetes mellitus medical care support" for a family doctor and follow the effect to decrease dropout rate in the outpatient clinic and the quality of diabetes care through various outcome scores.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Dropout rate of outpatients
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 1) Encourage the patients for regural checkups.
2)Patient education
3)Feedback of evaluatoion of doctor's patient care to these doctors and bench-marking.
Interventions/Control_2 Usual medical care
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
40 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria Type 2 diabetes patient diagnosed as below criteria
1) The patient satisfying criteria of Japan diabetes society
2) The patient diagnosed as diabetes mellitus in another hospital
3) The patient undergoing treatment by diabetes remedy (oral hypoglycemic agent, insulin)
Key exclusion criteria 1) The patient under hemodialysis
2) The patient who are admitted to the hospital
3) The bedridden patient or the practically bedridden patient
4) The patients who are resident in nursing homes
5) The patient with medical history of Blindness or leg amputation
6) The patient diagnosed as malignant disease in the last five years
7) The pregnant patient or the possible pregnant patient
8) The patients who are regularly followed for diabetes mellitus by two or more medical institutions (except for treatment of complication)
9) Type 1 diabetes mellitus or possible type 1 diabetes patient
Target sample size 3750

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masashi Kobayashi
Organization University of Toyama
Division name Graduate School of Medicine and Pharmaceutical Sciences for Research
Zip code
Address 2630 Sugitani, Toyama 930-0194 Japan
TEL 076-434-7258
Email

Public contact
Name of contact person
1st name
Middle name
Last name Katsuya Yamazaki
Organization University of Toyama
Division name Faculty of Medicine, Internal Medicine 1
Zip code
Address 2630 Sugitani, Toyama 930-0194 Japan
TEL 076-434-7287
Homepage URL http://www.jdoit2.jp/index.html
Email kyamazak@med.u-toyama.ac.jp

Sponsor
Institute Japan Foundation for the Promotion of International Medical Research Cooperation
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2009 Year 07 Month 13 Day

Related information
URL releasing protocol http://www.pimrc.or.jp/diabetes/research2_protocol_120.pdf
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 No longer recruiting
Date of protocol fixation
2009 Year 05 Month 07 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2010 Year 10 Month 01 Day
Date of closure to data entry
2010 Year 12 Month 01 Day
Date trial data considered complete
2011 Year 03 Month 01 Day
Date analysis concluded
2013 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 07 Month 12 Day
Last modified on
2012 Year 01 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002663

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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