UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049849 |
|---|---|
| Receipt number | R000055837 |
| Scientific Title | Association between patients' recognition of receiving a recommendation for ophthalmology consultation and actual fundus examination: A cross-sectional study using questionnaires linked with claims data in Japan |
| Date of disclosure of the study information | 2022/12/22 |
| Last modified on | 2024/01/12 11:26:09 |
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Basic information
Public title
Association between patients' recognition of receiving a recommendation for ophthalmology consultation and actual fundus examination: A cross-sectional study using questionnaires linked with claims data in Japan
Acronym
Association between patients' recognition of receiving a recommendation for ophthalmology consultation and actual fundus examination: A cross-sectional study using questionnaires linked with claims data in Japan
Scientific Title
Association between patients' recognition of receiving a recommendation for ophthalmology consultation and actual fundus examination: A cross-sectional study using questionnaires linked with claims data in Japan
Scientific Title:Acronym
Association between patients' recognition of receiving a recommendation for ophthalmology consultation and actual fundus examination: A cross-sectional study using questionnaires linked with claims data in Japan
Region
| Japan |
Condition
Condition
Diabetes Mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Based on the results of a questionnaire survey on lifestyle and diabetes conducted by Tsukuba City for administrative use, we will extract issues related to the medical treatment of patients with diabetes mellitus. We will also analyze the characteristics of patient backgrounds by using the data from Tsukuba City, which is a combination of the questionnaire survey and the information of specific health checkups and claims data of Tsukuba City.
Basic objectives2
Others
Basic objectives -Others
Patient Experience Survey
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Issues in Diabetes Care and Treatment
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
| 20 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with diabetes were selected from the population who were enrolled in the National Health Insurance of Tsukuba City as of September 2022, residing in Tsukuba City and aged 20-74 years as of October 31, 2022:
(1) Those who received at least one diabetic drug prescription (ATC classification: A10) in FY2021.
(ii) Those who had HbA1c of 6.5% or higher in the medical checkup in FY2021 and had not received a prescription for diabetes medication in the same year.
From this population, questionnaires were mailed to 1,000 patients selected by stratified random sampling method, and valid responses were used to include them in the study.
Key exclusion criteria
Patients with gestational diabetes mellitus (O244 and O249) in FY2021 were excluded.
Patients who were no longer insured at the time of sampling (November 2022) and patients who were unaware of their diabetes were excluded from the study.
In addition, no response or multiple responses to questions relevant to the study were excluded as invalid responses.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Nanako |
| Middle name | |
| Last name | TAMIYA |
Organization
Faculty of Medicine University of Tsukuba
Division name
Department of Health Services Research
Zip code
305-8577
Address
1-1-1 Tennodai, Tsukuba city, Ibaraki
TEL
029-853-8849
hsr@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Takehiro |
| Middle name | |
| Last name | SUGIYAMA |
Organization
Faculty of Medicine University of Tsukuba
Division name
Department of Health Services Research
Zip code
305-8577
Address
1-1-1 Tennodai, Tsukuba city, Ibaraki
TEL
029-853-8849
Homepage URL
hsr@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tsukuba City, National Center for Global Health and Medicine, The University of Tokyo
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Medicine University of Tsukuba,
Address
Department of Health Services Research
Tel
029-853-8849
hsr@md.tsukuba.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 | 12 | Month | 22 | 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
456
Results
47.6% recognized that their healthcareprovider had recommended an eye check, 72.8% knew thefrequency of eye check, and 50.5% had participated in afundus examination.
The proportion of fundus examinations per recognition of eye check recommendation was 72.9% vs.30.1%; the proportion of knowledgeof the frequency of eye checks per recognition ofeye check recommendation was 93.4% vs 49.6%;both suggesting a significant association.
Results date posted
| 2024 | Year | 01 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The patients with diabetes for the questionnaire survey were extracted from insurance claims data and health check-up data. The first inclusion criterion identified individuals covered by Tsukuba City's National Health Insurance as of September 2022 and aged 20-74 years as of October 31, 2022. From this group, patients with diabetes were selected according to the following conditions: (1) Those who have received at least one antidiabetic drug prescription (ATC classification : A10) in FY2021. (2) Those whose HbA1c was 6.5% or more in the health check-up in FY2021 and who have not received any diabetic medication prescription in the same year.
From the selected source population of patients with diabetes (n = 3,450), questionnaires were mailed to 1,000 patients chosen by a stratified random sampling method.
Participant flow
A total of 3,450 patients with diabetes were selected from the National Health Insurance registry of Tsukuba City. Among 1000questionnairesdistributed to the randomly selected patients, 290 valid responses were included in the main analysis.
Adverse events
No AE
Outcome measures
The primary outcome was actual participation in the fundus examination.
The secondary outcome was knowledge of the recommended frequency of eye checks.
Having knowledge of the recommended frequency of eye examinations was defined as selecting 'once every 6 months or more' or 'once a year.' based on the clinical guidelines in Japan.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
In this study, we use the results of a questionnaire survey conducted by Tsukuba City for patients with diabetes and the general population for the purposeof using the results in the formulation of the National Health Insurance Plan.
The results of the questionnaire will be matched with the results ofspecific health checkups, claims data, and the insurer registry held by the National Health Insurance Department of Tsukuba City. We will make theweights considering the background information and the response rate, and organize the simple tabulation, attribute cross tabulation, and freedescription.
Management information
Registered date
| 2022 | Year | 12 | Month | 21 | Day |
Last modified on
| 2024 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055837
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