UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Japan DM Adherence Tracking Effectiveness Study
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	TERAMOTO Tamio
Organization	School of Medicine, Teikyo University
Division name	Division of Clinical Medicine
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	HASHIMOTO Sora
Organization	United Health Communication Co., Ltd.
Division name	None
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 12 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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