UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057716 |
|---|---|
| Receipt number | R000065824 |
| Scientific Title | Study of the Effect of Diabetes Education for College Students on the Well-Being of Diabetic Families |
| Date of disclosure of the study information | 2025/04/25 |
| Last modified on | 2025/04/25 00:02:04 |
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Basic information
Public title
Study of the Effect of Diabetes Education for College Students on the Well-Being of Diabetic Families
Acronym
Study of the Effect of Diabetes Education for College Students on the Well-Being of Diabetic Families
Scientific Title
Study of the Effect of Diabetes Education for College Students on the Well-Being of Diabetic Families
Scientific Title:Acronym
Study of the Effect of Diabetes Education for College Students on the Well-Being of Diabetic Families
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine changes in subjective wellbeing indices of diabetic patients by communicating the content of a diabetes education program received by university student diabetes supporters to their families who are diabetic patients.
Basic objectives2
Others
Basic objectives -Others
[Diabetic patients].
The following changes before and after the diabetes education program will be evaluated.
Diabetes control index (HbA1c, weight)
Changes in hospital visits, medication adherence, and lifestyle (questionnaire)
Social network indicators (UCLA Loneliness Scale)
K6 (a questionnaire academically reviewed as a screening for mood and anxiety disorders including depression)
University Student Supporters
The following changes before and after the diabetes education program will be evaluated.
The following changes will be assessed before and after the diabetes education program: - Level of understanding of the diabetes education program (confirmation test)
Satisfaction With Life Scale (SWLS), Ryff's psychological WB scale
K6 (a questionnaire academically reviewed as a screening for mood and anxiety disorders including depression)
Behavioral changes in one's health (questionnaire)
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Satisfaction With Life Scale (SWLS) and Ryff's psychological WB scale as indicators of subjective wellbeing
At the beginning of the study and after 40 weeks
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
| Other |
Interventions/Control_1
Communicate the content of the diabetes education program received by university student diabetes supporters to their families who are diabetics.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
University Student Supporters
1. Must be an undergraduate or graduate student enrolled at Kobe University.
2. Have a family member who is eligible for the [Diabetic] program. (Whether living together or living separately is not required.
3. Have access to equipment that allows them to take the online program.
4. Have agreed to take the online educational program and to explain it to the applicable [diabetic patient] after passing the confirmation test.
5. Have agreed to participate in the study and have obtained informed consent.
Diabetic patients
1. Patients with type 2 diabetes who have been visiting the hospital regularly for diabetes and whose HbA1c has been measured by blood test.
2. Must be able to communicate with university student supporters.
3. Be able to send and receive questionnaires by mail.
4. Have agreed to participate in the study and have given informed consent.
Key exclusion criteria
University Student Supporters
1. Students who are expected to graduate by the end of September 2025.
2. Those who are deemed unsuitable by the research staff.
Diabetics
1. Those who are hospitalized.
2. Those who are under 20 years old
3. those whose HbA1c, medication and complication information within the past 3 months, and weight at the time of consent are unknown.
4. Other persons who are deemed inappropriate by the investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Maki |
| Middle name | |
| Last name | Kimura-Koyanagi |
Organization
Kobe University
Division name
Inclusive Campus and Healthcare Center
Zip code
657-8501
Address
1-1 Rokkodai-cho Nada Kobe
TEL
(078)803-5245
koyanagi@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Maki |
| Middle name | |
| Last name | Kimura-Koyanagi |
Organization
Kobe University
Division name
Inclusive Campus and Healthcare Center
Zip code
657-8501
Address
1-1 Rokkodai-cho Nada Kobe
TEL
(078)803-5245
Homepage URL
koyanagi@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
The Shinohara Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Hospital Clinical and Translational Research Center
Address
7-5-2 Kusumoki-cho Chuo Kobe
Tel
0783825400
ctrc-sec@med.kobe-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
| 2025 | Year | 04 | Month | 25 | 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 | 04 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | 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 | 04 | Month | 25 | Day |
Last modified on
| 2025 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065824
