UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057239 |
|---|---|
| Receipt number | R000063154 |
| Scientific Title | Verification of the change in the follow-up rate in the notice of recommendation to take a secondary health checkups for those with findings in the annual health checkups |
| Date of disclosure of the study information | 2025/03/08 |
| Last modified on | 2026/07/09 20:51:42 |
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Basic information
Public title
Verification of the change in the follow-up rate in the notice of recommendation to take a secondary health checkups for those with findings in the annual health checkups
Acronym
Verification of the change in the follow-up rate in the notice of recommendation to take a secondary health checkups for those with findings in the annual health checkups
Scientific Title
Verification of the change in the follow-up rate in the notice of recommendation to take a secondary health checkups for those with findings in the annual health checkups
Scientific Title:Acronym
Verification of the change in the follow-up rate in the notice of recommendation to take a secondary health checkups for those with findings in the annual health checkups
Region
| Japan |
Condition
Condition
Noncommunicable diseases
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verificate the change in the appointment status and follow-up rate in the notice of nudge-based recommendation to take a follow-up examination for those with findings in the annual health check
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Percentage of reporting appointment status and taking the follow-up examinations
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Reference group
The initial and reminder notifications were based on the previously used ones by the company with some modifications. The initial notification instructed recipients to independently arrange an appointment and report their appointment status within three weeks. The reminder notification added that it was being sent to workers who had not reported by the deadline . The notifications in the reference group incorporated elements designed to encourage consultation by declaring a time and place (a commitment nudge; corresponding to Social Nudge). Moreover, the notifications included a photograph of an expert, along with her name, professional affiliations, and job title, as well as an additional explanation of the commitment conceptAdditional information.
Interventions/Control_2
Nudge group
The initial notification was developed based on prior research. In addition to the nudges included in the reference group's notification, this version explicitly specified the medical institution to be visited, enhancing easy application (Easy Nudge). In the reminder notification, final is displayed on the first line to prevent procrastination (Timely Nudge). Furthermore, it featured a four-frame comic strip to capture attention (Attractive Nudge) and provided an explanation of how reporting schedule status will encourage them, thereby making the existence of the Social Nudge explicit.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The Inclusion criteria was workers who received the notifications.
Key exclusion criteria
The exclusion criteria were workers who engaged in industrial health and who did not agree with the study
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Takebayashi |
Organization
Aomori University
Division name
Faculty of Sociology
Zip code
030-0943
Address
Aomori-ken Aomori-shi Koubata 2-3-1
TEL
09036442115
1691001@ms.auhw.ac.jp
Public contact
Name of contact person
| 1st name | Kiyohito |
| Middle name | |
| Last name | Kiyokawa |
Organization
Aomori University
Division name
Faculty of Sociology, IRB
Zip code
030-0943
Address
Aomori-ken Aomori-shi Koubata2-3-1
TEL
017-738-2001
Homepage URL
1691001@ms.auhw.ac.jp
Sponsor or person
Institute
Aomori University
Institute
Department
Personal name
Funding Source
Organization
This research was funded by Nippon Boehringer Ingelheim Co., Ltd. and Eli Lilly Japan, K.K., with MT and YM receiving funding from the research team.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aomori University Faculty of Sociology IRB
Address
Aomori-ken Aomori-shi Koubata2-3-1
Tel
017-738-2001
1691001@ms.auhw.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 | 03 | Month | 08 | Day |
Related information
URL releasing protocol
No
Publication of results
Unpublished
Result
URL related to results and publications
Not yet
Number of participants that the trial has enrolled
332
Results
Participants were geographically assigned to either the basic EAST group (n = 210) or the additional EAST group (n = 122). Attendance at follow-up examinations was significantly higher in the basic EAST group than in the additional EAST group.
Results date posted
| 2026 | Year | 07 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
No significant differences were observed in the baseline characteristics between the groups.
Participant flow
Workers with abnormal findings on their routine health checkups initially received a mailed notification from the company encouraging them to undergo follow-up examinations. Recipients were instructed to report their appointment status. If they did not respond within three weeks, a reminder notification was mailed to them.
Adverse events
No
Outcome measures
The primary outcome was attendance at follow-up examinations. Completion of the follow-up examinations was assessed based on workers' self-reports and subsequently verified using medical claims data submitted by healthcare providers. The secondary outcome was the reported appointment status at medical institutions.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 03 | Month | 08 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 08 | Day |
Last modified on
| 2026 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063154
