UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052489 |
|---|---|
| Receipt number | R000059897 |
| Scientific Title | Diabetes-related Stigma and Advocacy Activity in Fukushima Survey |
| Date of disclosure of the study information | 2023/10/14 |
| Last modified on | 2023/10/13 15:46:21 |
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Basic information
Public title
Diabetes-related Stigma and Advocacy Activity in Fukushima Survey
Acronym
DiaSAAF survey
Scientific Title
Diabetes-related Stigma and Advocacy Activity in Fukushima Survey
Scientific Title:Acronym
DiaSAAF survey
Region
| Japan |
Condition
Condition
Adults with diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this multi-center questionnaire study, we aim to explore the prevalence and clinical correlates of self-perceived stigma and survey the awareness of stigma and advocacy activities in adults with diabetes living in Fukushima prefecture.
Basic objectives2
Others
Basic objectives -Others
A collective assessed score for perceived and self-perceived stigma was higher in individuals with T1D and T2D on insulin compared to those with T2D not taking insulin. Nevertheless, there is limited information available regarding the prevalence and clinical associations of self-perceived stigma in Japanese individuals with diabetes.
Since August 4, 2019, the Japan Diabetes Society (JDS) and Japan Association for Diabetes Education and Care (JADEC) have set up a joint committee to tackle and overcome DRS. However, the proportion of knowing the terms' stigma' and 'advocacy' in Japanese general physicians is only approximately 40% by 2022 23, and none of the studies have addressed the awareness of these terms in Japanese people with diabetes.
The aim of this study is to address the insufficient knowledge regarding "stigma" and "advocacy" mentioned above.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In adults with diabetes living in Fukushima prefecture,
1. the prevalence and clinical correlates of self-perceived stigma
2. the awareness of stigma and advocacy activities
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eligible participants are Japanese adults (aged 18 years or older) with type 1 or 2 diabetes recruited from the outpatient clinic of Takeda General Hospital, Taneda Clinic, Seino Internal Medical Clinic, Umetsu LS Clinic, and the diabetes center at Ohta Nishinouchi Hospital.
Key exclusion criteria
We exclude individuals with the following conditions based on the attending physicians' judgment: mental health/psychological disorders; conditions requiring emergency treatment, such as acute infection or trauma; malignant diseases; unwillingness of the study participation.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Sugimoto |
Organization
Ohta Nishinouchi Hospital
Division name
Diabetes Center
Zip code
963-8558
Address
2-5-20, Nishinouchi, Koriyama, Fukushima
TEL
024-925-1188
kasugi@crux.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Sugimoto |
Organization
Ohta Nishinouchi Hospital
Division name
Diabetes Center
Zip code
963-8558
Address
2-5-20, Nishinouchi, Koriyama, Fukushima
TEL
024-925-1188
Homepage URL
kasugi@crux.ocn.ne.jp
Sponsor or person
Institute
Ohta Nishinouchi Hospital
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Ohta Nishinouchi Hospital
Address
2-5-20 Nishinouchi, Koriyama, Fukushima
Tel
0249251188
m-ohta@ohta-hp.or.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
| 2023 | Year | 10 | Month | 14 | 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 | 12 | Month | 03 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2023 | Year | 10 | Month | 13 | Day |
Last modified on
| 2023 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059897
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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