UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042897 |
|---|---|
| Receipt number | R000048967 |
| Scientific Title | Study on effects of "online education and life improvement program for diabetic patients" on behavior change, biochemical parameter, and related factors. |
| Date of disclosure of the study information | 2021/01/04 |
| Last modified on | 2023/04/07 08:06:32 |
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Basic information
Public title
Study on effects of "online education and life improvement program for diabetic patients" on behavior change, biochemical parameter, and related factors.
Acronym
Study on effects of "online education and life improvement program for diabetic patients" on behavior change, biochemical parameter, and related factors.
Scientific Title
Study on effects of "online education and life improvement program for diabetic patients" on behavior change, biochemical parameter, and related factors.
Scientific Title:Acronym
Study on effects of "online education and life improvement program for diabetic patients" on behavior change, biochemical parameter, and related factors.
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to build a program that brings change to one's behavior.
The program will refer to in-hospital diabetes educational program, and designed to be safe (not to worsen the patient's condition) under the direction of a doctor.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c
weight
BMI
Key secondary outcomes
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
| Food | Behavior,custom |
Interventions/Control_1
Provide online educational program for a week, and observe their change for 3 weeks after the program.
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Diabetic patients of the University of Tsukuba Hospital
2) Patients whose HbA1c is more than 7.0 % and less than 7.9 %
3) Patients aged between 20 and 65 at the start of this clinical trial
4) Patients who are not taking sulfonylureas or injecting insulin at the start of this clinical trial
5) Patients who can walk about 6,000 steps a day
6) Patients who have difficulty in normal education hospitalization
Key exclusion criteria
1) Patients with severe infections, before or after operations or having serious external injuries at the time of agreement acquisition
2) Patients with exercise restrictions (reduced renal function (eGFR < 30), progressive retinopathy)
3) Pregnant women, lactating women, or women who have possibility of pregnancy
4) Patients who do not own smartphone
5) Patients who are judged to be inappropriate by the research managers
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Yahagi |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
305-8575
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki
TEL
029-853-3053
nyahagi-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Noya |
| Middle name | |
| Last name | Yahagi |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
305-8575
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki
TEL
029-853-3053
Homepage URL
nyahagi-tky@umin.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
JMDC Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Habitus Care Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba
Address
1-1-1 Tennoundai, Tsukuba, Ibaraki
Tel
029-853-3053
nyahagi-tky@umin.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
筑波大学附属病院（茨城県）、調布東山病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
15
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
Completed
Date of protocol fixation
| 2020 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 15 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 04 | Day |
Last modified on
| 2023 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048967
