UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028134 |
|---|---|
| Receipt number | 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 | 2020/11/12 17:59:00 |
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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
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
ahayashi@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
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
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
https://www.jsmcn.jp/members/users/doc_download/2020/jsmcn_Vol.23No.2_part2.pdf
Publication of results
Published
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
26
Results
In 15 patients of Map group and 11 of usual Program group, overall PAID did not differ before and after Program, however PAID in Map group decreased significantly after Program with Map compared with before attendance, and there was not significant difference in usual Program group. HbA1c significantly decreased after discharge in all patients. HbA1c in Map group was significantly lower than in usual Program group at 6 months after discharge.
Results date posted
| 2020 | Year | 01 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
26 administrated patients with diabetes (17 males, 58 years old, HbA1c 10.8%) who took Program
Participant flow
15 patients of Map group and 11 of usual Program group
Adverse events
None
Outcome measures
Overall PAID did not differ before and after Program, however PAID in Map group decreased significantly after Program with Map compared with before attendance, and there was not significant difference in usual Program group. HbA1c significantly decreased after discharge in all patients. HbA1c in Map group was significantly lower than in usual Program group at 6 months after discharge.
Plan to share IPD
None
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2019 | Year | 12 | Month | 11 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 11 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 11 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 07 | Day |
Last modified on
| 2020 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032207
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