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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017681
Receipt No. 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

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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
Email 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
Email hashimoto@uhc.jp

Sponsor
Institute MSD K.K.
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020496

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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