UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053963 |
|---|---|
| Receipt number | R000059514 |
| Scientific Title | An approach to improving lifestyle habits using smartphones for patients with diabetes |
| Date of disclosure of the study information | 2024/03/26 |
| Last modified on | 2024/03/25 13:41:32 |
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Basic information
Public title
An approach to improving lifestyle habits using smartphones for patients with diabetes
Acronym
Smartphone Lifestyle Improvement Study for Diabetic Patients
Scientific Title
An approach to improving lifestyle habits using smartphones for patients with diabetes
Scientific Title:Acronym
Smartphone Lifestyle Improvement Study for Diabetic Patients
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessing the Efficacy of Remote Lifestyle Intervention (Utilizing Mobile Messenger Applications for Information Dissemination and Remote Therapeutic Guidance) for Type 2 Diabetes Patients (including individuals with diabetes and obesity) Residing in Hiroshima Prefecture, Conducted by Hiroshima University
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to exploratively gather information on whether remote lifestyle intervention (therapeutic guidance through telephonic communication) conducted by Hiroshima University can prevent the exacerbation of diabetes, improve dietary habits, and enhance physical function (exercise habits, step count, etc.) in patients with diabetes who attend their regular physicians in areas lacking diabetes medical centers or core hospitals.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in HbA1c, blood pressure, and stages of behavior
Key secondary outcomes
Changes in exercise habits (step count) and weight
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
| Behavior,custom |
Interventions/Control_1
Using a messaging tool, doctors, nurses, and physiotherapists of the research office will carry out diabetes care guidance and patient education. Information related to patient education will be sent three times a week. The Physiotherapists and nurses will conduct remote interventions on lifestyle habits (such as exercise guidance, care guidance, etc.) via phone or video call for the patients.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes patients.
Patients who own a personal smartphone and can operate it themselves.
Patients for whom informed consent for participation in this study is obtained in writing and based on their own volition.
Key exclusion criteria
Patients with diabetes other than type 2 diabetes (type 1 diabetes, gestational diabetes, diabetes due to other causes).
Patients undergoing dialysis treatment.
Other patients deemed unsuitable for the implementation of this study by the principal investigator and co-investigators.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Haruya |
| Middle name | |
| Last name | Ohno |
Organization
Hiroshima University Hospital
Division name
Endocrinology and Diabetic Medicine
Zip code
734-8551
Address
1-2-3 Kasumi, Minami Ward, Hiroshima City, Hiroshima Prefecture
TEL
082-257-1784
haruya-ohno@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Haruya |
| Middle name | |
| Last name | Ohno |
Organization
Hiroshima University Hospital
Division name
Endocrinology and Diabetic Medicine
Zip code
734-8551
Address
1-2-3 Kasumi, Minami Ward, Hiroshima City, Hiroshima Prefecture
TEL
082-257-1784
Homepage URL
haruya-ohno@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hiroshima Prefecture Regional Medical Care and Nursing Comprehensive Security Fund
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3 Minami-Ku, Hiroshima
Tel
082-257-1947
iryo-sinsa@office.hiroshima-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
| 2024 | Year | 03 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 25 | Day |
Last modified on
| 2024 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059514
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
