UMIN-CTR Clinical Trial

Recruitment status Terminated
Unique ID issued by UMIN UMIN000023095
Receipt No. R000026618
Scientific Title Efficacy of Diabetes Conversation MapTM in Diabetes Education for Glycemic Control
Date of disclosure of the study information 2016/07/28
Last modified on 2019/04/27 (Ver. 3)

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Basic information
Public title Efficacy of Diabetes Conversation MapTM in Diabetes Education for Glycemic Control
Acronym Efficacy of Diabetes Conversation MapTM
Scientific Title Efficacy of Diabetes Conversation MapTM in Diabetes Education for Glycemic Control
Scientific Title:Acronym Efficacy of Diabetes Conversation MapTM
Region
Japan

Condition
Condition Patients with type 2 diabetes
Classification by specialty
Medicine in general Endocrinology and Metabolism Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the differences of glycemic control and diabetes-related distress between conventional education group and Conversation MapTM education group.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes The differences of HbA1c and diabetes-related distress examined by The Problem Areas in Diabetes Scale (PAID).
Key secondary outcomes Blood pressure, body weight, renal function, the stage of diabetic nephropathy, liver function and lipid profile.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Behavior,custom
Interventions/Control_1 Diabetic education program using Diabetes Conversation MapTM
Interventions/Control_2 Conventional diabetic education program without Diabetes Conversation MapTM
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients with type 2 diabetes mellitus hospitalized in Kitasato University Hospital and taken part in a diabetic self-management education program.
Key exclusion criteria (1) Type 1 diabetes, secondary diabetes, and glucose intolerance with pregnancy
(2) Patients with psychiatric disorder
(3) Patients with dementia
(4) Patients undergoing preoperative glycemic control
(5) Patients be ruled unfit to education program and Conversation MapTM by attending physician
Target sample size 100

Research contact person
Last name of lead principal investigator
1st name Yuko
Middle name
Last name Kawakami
Organization Kitasato University Hospital
Division name Nourishment Part
Zip code 252-0374
Address 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL 042-778-8111
Email qq9v93md@coast.ocn.ne.jp

Public contact
1st name of contact person
1st name Akinori
Middle name
Last name Hayashi
Organization Kitasato Universtiy School of Medicine
Division name Endocrinology, Diabetes and Metabolism
Zip code 252-0374
Address 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL 042-778-8111
Homepage URL
Email ahayashi@kitasato-u.ac.jp

Sponsor
Institute Kitasato Universtiy School of Medicine. Division of Endocrinology, Diabetes and Metabolism.
Institute
Department

Funding Source
Organization Kitasato University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization the Ethics Committee of Kitasato University Hospital
Address 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
Tel 042-778-7756
Email onoya@kitasato-u.ac.jp

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 北里大学病院（神奈川県）

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 28 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 
Discontinuation because of insufficient study protocol.
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 Terminated
Date of protocol fixation
2016 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
2016 Year 10 Month 01 Day
Date of closure to data entry
2016 Year 10 Month 01 Day
Date trial data considered complete
2016 Year 10 Month 01 Day
Date analysis concluded
2016 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2016 Year 07 Month 10 Day
Last modified on
2019 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026618