UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002186 |
|---|---|
| Receipt number | 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 21:28:37 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
kyamazak@med.u-toyama.ac.jp
Sponsor or person
Institute
Japan Foundation for the Promotion of International Medical Research Cooperation
Institute
Department
Personal name
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
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
Value
https://center6.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 |
