UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054924 |
|---|---|
| Receipt number | R000062750 |
| Scientific Title | Survey of Diabetes Stigma in Ophthalmology Patients |
| Date of disclosure of the study information | 2024/07/22 |
| Last modified on | 2024/07/10 13:55:29 |
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Basic information
Public title
Survey of Diabetes Stigma in Ophthalmology Patients
Acronym
Survey of Diabetes Stigma in Ophthalmology Patients
Scientific Title
Survey of Diabetes Stigma in Ophthalmology Patients
Scientific Title:Acronym
Survey of Diabetes Stigma in Ophthalmology Patients
Region
| Japan |
Condition
Condition
DM
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The idea of diabetes advocacy is gaining popularity, but there are very few reports from physicians on the actual situation of stigma and advocacy activities. There have been no reports from ophthalmology, and this is the first study in Japan on diabetes advocacy that can be done from the perspective of ophthalmology. Ophthalmology, like internal medicine, requires visits to the hospital, and since visual function is directly related to daily life, this study from the perspective of an internist and an ophthalmologist is a novel and meaningful research project.
Basic objectives2
Others
Basic objectives -Others
survey
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
survey
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients who are between 20 and 90 years of age at the time of consent
2) Patients with diabetes mellitus
3) Patients who have received a thorough explanation of the study and who have given their free and voluntary written consent based on a thorough understanding of the study.
Key exclusion criteria
1) Persons deemed unsuitable by the principal investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | kaiho |
| Middle name | |
| Last name | tomomi |
Organization
Chiba university hospital
Division name
Ophthalmology
Zip code
2630024
Address
Chiba City, Chuo-ku, Inohana 1-8-1
TEL
0432262484
tomomif24@gmail.com
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Sugawara |
Organization
Chiba University Hospital
Division name
Ophthalmology
Zip code
2630024
Address
Chiba City, Chuo-ku, Inohana 1-8-1
TEL
0432262484
Homepage URL
takeshis@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
NON
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Hospital
Address
Chiba City, Chuo-ku, Inohana 1-8-1
Tel
0432227171
takeshis@faculty.chiba-u.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 | 07 | Month | 22 | 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
| 2024 | Year | 03 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
questionnaire survey
Management information
Registered date
| 2024 | Year | 07 | Month | 10 | Day |
Last modified on
| 2024 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062750
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
