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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028134
Receipt No. R000032207
Scientific Title Efficacy of Diabetes Conversation Map TM in Diabetic education for Glycemic Control and Emotional Distress.
Date of disclosure of the study information 2017/07/10
Last modified on 2019/07/10

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Basic information
Public title Efficacy of Diabetes Conversation Map TM in Diabetic education for Glycemic Control and Emotional Distress.
Acronym Efficacy of Diabetes Conversation Map TM in Diabetic education
Scientific Title Efficacy of Diabetes Conversation Map TM in Diabetic education for Glycemic Control and Emotional Distress.
Scientific Title:Acronym Efficacy of Diabetes Conversation Map TM in Diabetic education
Region
Japan

Condition
Condition Patinets with 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 emotional distress between conventional education group and Conversation Map TM 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

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) Patients undergoing preoperative glycemic control
(2) Patients with psychiatric disorder
(3) Patients with dementia
(4) Patients be ruled unfit to education program and Conversation MapTM by attending physician
Target sample size 200

Research contact person
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
Name of contact person
1st name Akinori
Middle name
Last name Hayashi
Organization Kitasato University School of Medicine
Division name Endocrinology, Diabetes and Metabolism
Zip code 252-0374
Address 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL 042-778-8706
Homepage URL
Email ahayashi@kitasato-u.ac.jp

Sponsor
Institute Kitasato University
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 Kitasato University Medical Ethics Organization (KMEO)
Address 1-15-1 Kitasato, Minami-ku, Sagamihara
Tel 0427788111
Email rinrib@med.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

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 10 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
2016 Year 12 Month 22 Day
Date of IRB
2016 Year 12 Month 22 Day
Anticipated trial start date
2016 Year 12 Month 22 Day
Last follow-up date
2019 Year 07 Month 31 Day
Date of closure to data entry
2020 Year 01 Month 31 Day
Date trial data considered complete
2020 Year 01 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 07 Day
Last modified on
2019 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032207

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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