UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of The Treatment Dropout Prevention Practice Manual for Diabetes :A pilot study
Title of the study (Brief title)	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	Mitsuhiko Noda
Organization	Research Institute, National Center for Global Health and Medicine
Division name	Department of Diabetes Research, Diabetes Research Center
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo 162-8655, Japan
TEL	+81-3-3202-7181
Email	noda-3im@io.ocn.ne.jp

Public contact
Name of contact person	Hiroshi Noto
Organization	St Luke's International Hospital
Division name	Endocrinology Department
Address	9-1 Akashi-Cho, Chuo-ku, Tokyo 104-8560, Japan
TEL	+81-3-3541-5151
Homepage URL
Email	noto-tky@umin.net

Sponsor
Institute	Research Institute, National Center for Global Health and Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021273