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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||||
Condition | type-2 diabetes | |||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 720 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |