UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017681 |
|---|---|
| Receipt number | R000020496 |
| Scientific Title | Japan DM Adherence Tracking Effectiveness Study |
| Date of disclosure of the study information | 2015/05/26 |
| Last modified on | 2016/06/29 11:30:50 |
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Basic information
Public title
Japan DM Adherence Tracking Effectiveness Study
Acronym
J-DATE Study
Scientific Title
Japan DM Adherence Tracking Effectiveness Study
Scientific Title:Acronym
J-DATE Study
Region
| Japan |
Condition
Condition
type-2 diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Japan DM Adherence Tracking Effectiveness Study
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
medication adherence measured by MMAS-4
Key secondary outcomes
Pharmacy visit rate
Variable Medication Possession Ratio; VMPR or variable MPR
Attitude toward taking medicines
Understanding levels of illness and treatment
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
An intervention group and control group will be set up, and the intervention group will participate in the "Kusurism" adherence support program for three months.
Interventions/Control_2
pretest/posttest
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
Subjects who are 20 years or older
Subjects who are taking at least one oral hypoglycemic agent.
Subjects who are visiting a Nihon-Chouzai pharmacy in Tokyo.
Subjects who have access to internet-based services.
Subjects who give informed consent.
Key exclusion criteria
Subjects who have a planned hospitalization in the next 6 months or are in a nursing home
Subjects who cannot or do not want to operate a computer or never use web-based services
Subjects who are receiving or plan to start renal dialysis
Subjects who have prescription histories for depression, dementia, Parkinson's disease, or schizophrenia.
Target sample size
720
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | TERAMOTO Tamio |
Organization
School of Medicine, Teikyo University
Division name
Division of Clinical Medicine
Zip code
Address
2-11-1 Kaga, Itabashi City, Tokyo, Japan
TEL
03-3964-1211
ttera@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | HASHIMOTO Sora |
Organization
United Health Communication Co., Ltd.
Division name
None
Zip code
Address
Nihonbashi-KK Bld.2F, 10-16, Nihonbashi Tomisawa-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6661-1154
Homepage URL
hashimoto@uhc.jp
Sponsor or person
Institute
MSD K.K.
Institute
Department
Personal name
Funding Source
Organization
MSD K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nihon Chouzai Co., Ltd.
Japan Medical Research Institute Co, Ltd.
Teikyo University Centre for Evidence-Based Medicine
School of Pharmacy, Nihon University
Macromill, Inc.
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
日本調剤山手薬局（東京都）、日本調剤高野台薬局（東京都）、日本調剤御成門薬局（東京都）、日本調剤まつやま薬局（東京都）、日本調剤新青戸薬局（東京都）、日本調剤弥生薬局（東京都）、日本調剤葛西薬局（東京都）、日本調剤町田薬局（東京都）、日本調剤大和田薬局（東京都）、日本調剤葛飾薬局（東京都）、日本調剤マグノリア薬局（東京都）、日本調剤三田薬局（東京都）、日本調剤飯田橋西口薬局（東京都）、日本調剤大森薬局（東京都）、日本調剤旭が丘薬局（東京都）、日本調剤福生薬局（東京都）、日本調剤湯島薬局（東京都）、日本調剤台東薬局（東京都）、日本調剤江東薬局（東京都）、日本調剤虎ノ門薬局（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 26 | 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
| 2014 | Year | 12 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 09 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 26 | Day |
Last modified on
| 2016 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020496
