UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049152 |
|---|---|
| Receipt number | R000055990 |
| Scientific Title | Feasibility study of an online health guidance program for home diabetic patients using Diabetic Nephropathy Aggravation Prevention Notebook Application |
| Date of disclosure of the study information | 2022/10/16 |
| Last modified on | 2024/04/08 13:50:58 |
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Basic information
Public title
Feasibility study of an online health guidance program using Diabetic Nephropathy Aggravation Prevention Notebook Application for diabetic patients living at home
Acronym
Feasibility study of an online health guidance program using an application
Scientific Title
Feasibility study of an online health guidance program for home diabetic patients using Diabetic Nephropathy Aggravation Prevention Notebook Application
Scientific Title:Acronym
A feasibility study of an online health guidance program for diabetes patients at home using applications
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is a feasibility study (pilot study) of an online health guidance program. Therefore, the purpose of this study is to implement an online health guidance program for diabetic patients at home using the "Diabetic Nephropathy Aggravation Prevention Notebook Application" running on a smartphone currently under development, and to investigate the usability of the application and their impression of the online health guidance program.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in willingness and ability for self-management of diabetes patients before and after the online health guidance program
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
| Behavior,custom |
Interventions/Control_1
Implement an online health guidance program using the "Diabetic Nephropathy Aggravation Prevention Notebook Application".
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Intended for patients who meet all of the following criteria.
1.Patients aged 20 to 80
2. Patients with type II diabetes who are outpatients of internal medicine at Hamamatsu University School of Medicine Hospital
3. A person who has obtained consent for this study by signing the consent form
4. Patients who use smartphones on a daily basis
5. Patients with stage 1 or 2 diabetic nephropathy
Key exclusion criteria
Patients who meet any of the following conditions will not be included in this study.
1. Those with infectious diseases
2. Patients with type 1 diabetes
3. Patients undergoing dialysis treatment
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Keigo |
| Middle name | |
| Last name | Inagaki |
Organization
Hamamatsu University School of Medicine
Division name
Faculty of Nursing
Zip code
431-3192
Address
1-20-1 Handayama,Higashi-ku,Hamamatsu, Shizuoka, Japan
TEL
053-435-2511
kinagaki@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Keigo |
| Middle name | |
| Last name | Inagaki |
Organization
Hamamatsu University School of Medicine
Division name
Faculty of Nursing
Zip code
431-3192
Address
1-20-1 Handayama,Higashi-ku,Hamamatsu, Shizuoka, Japan
TEL
053-435-2511
Homepage URL
kinagaki@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine
Address
1-20-1 Handayama,Higashi-ku,Hamamatsu, Shizuoka, Japan
Tel
053-435-2511
kinagaki@hama-med.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
| 2022 | Year | 10 | Month | 16 | 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
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
| 2022 | Year | 09 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | 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
| 2022 | Year | 10 | Month | 07 | Day |
Last modified on
| 2024 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055990
| 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 |
