UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018373 |
|---|---|
| Receipt number | R000021273 |
| Scientific Title | Effects of The Treatment Dropout Prevention Practice Manual for Diabetes :A pilot study |
| Date of disclosure of the study information | 2015/07/24 |
| Last modified on | 2018/01/26 13:47:08 |
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Basic information
Public title
Effects of The Treatment Dropout Prevention Practice Manual for Diabetes :A pilot study
Acronym
Effects of The Treatment Dropout Prevention Practice Manual for Diabetes :A pilot study
Scientific Title
Effects of The Treatment Dropout Prevention Practice Manual for Diabetes :A pilot study
Scientific Title:Acronym
Effects of The Treatment Dropout Prevention Practice Manual for Diabetes :A pilot study
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effect of "The Treatment Dropout Prevention Practice Manual for Diabetes" on prevention of treatment dropout in patients with type 2 diabetes who are attending GPs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of treatment dropout before and after the intervention.
Key secondary outcomes
The impression of the effectiveness of the manual, the state of implementation, the easiness to implement, the will of utilization.
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
| Other |
Interventions/Control_1
Objects:GPs
The distribution and the training using "The Treatment Dropout Prevention Practice Manual for Diabetes".
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Japanese GPs are included if they engage in care for diabetes.
Key exclusion criteria
The diabetologist
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuhiko Noda |
Organization
Research Institute, National Center for Global Health and Medicine
Division name
Department of Diabetes Research, Diabetes Research Center
Zip code
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo 162-8655, Japan
TEL
+81-3-3202-7181
noda-3im@io.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Noto |
Organization
St Luke's International Hospital
Division name
Endocrinology Department
Zip code
Address
9-1 Akashi-Cho, Chuo-ku, Tokyo 104-8560, Japan
TEL
+81-3-3541-5151
Homepage URL
noto-tky@umin.net
Sponsor or person
Institute
Research Institute, National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
Health Labour Sciences Research Grant.
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japan Medical Association
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
| 2015 | Year | 07 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2015 | Year | 07 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 21 | Day |
Last modified on
| 2018 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021273
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
