UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058801 |
|---|---|
| Receipt number | R000067241 |
| Scientific Title | Development of new nursing model to support home care for elderly diabetic patients with insulin therapy using Personal Health Records (PHR) |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2025/08/14 16:21:32 |
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Basic information
Public title
Development of new nursing model to support home care for elderly diabetic patients with insulin therapy using Personal Health Records (PHR)
Acronym
Development of new nursing model to support home care for elderly diabetic patients with insulin therapy
Scientific Title
Development of new nursing model to support home care for elderly diabetic patients with insulin therapy using Personal Health Records (PHR)
Scientific Title:Acronym
Development of new nursing model to support home care for elderly diabetic patients with insulin therapy
Region
| Japan |
Condition
Condition
diabetes
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Develop a remote home care support model utilizing PHR for elderly diabetic patients using insulin, and explore its feasibility.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c levels following nursing intervention using remote monitoring
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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Support for diabetes management through chat functions on an app and video calls by nurses.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Diabetic patients aged 65 and older receiving insulin injections more than once a day
(2) Patients who can understand the content of this survey
(3) Patients who use smartphones and can use applications
Key exclusion criteria
(1)patients who are considered to be impropriety for the participation in this study by physician.
(2) Patients with mental disorders
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Miki |
| Middle name | |
| Last name | Nagafuchi |
Organization
Faculty of medicine,Saga University
Division name
Nursing
Zip code
849-8501
Address
5-1-1Nabeshima,Saga
TEL
0952-31-6511
arakimi@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Miki |
| Middle name | |
| Last name | Nagafuchi |
Organization
Faculty of medicine,Saga University
Division name
Nursing
Zip code
849-8501
Address
5-1-1Nabeshima,Saga
TEL
0952-31-6511
Homepage URL
arakimi@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
Funding Source
Organization
JSPSkAKENHI
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
clinical reserch center saga university hospital
Address
5-1-1Nabeshima,saga
Tel
0952-31-6511
kenkyu-shinsei@ml.cc.saga-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
| 2026 | Year | 04 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 08 | Month | 14 | Day |
Last modified on
| 2025 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067241
