UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042509 |
|---|---|
| Receipt number | R000048485 |
| Scientific Title | Effect of print reminder aimed at reducing inequality in participation in general health check-up: a randomized controlled study |
| Date of disclosure of the study information | 2020/11/26 |
| Last modified on | 2021/07/28 16:08:34 |
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Basic information
Public title
Effect of print reminder aimed at reducing inequality in participation in general health check-up: a randomized controlled study
Acronym
Print reminder reducing inequality in participation in general health check-up
Scientific Title
Effect of print reminder aimed at reducing inequality in participation in general health check-up: a randomized controlled study
Scientific Title:Acronym
Print reminder reducing inequality in participation in general health check-up
Region
| Japan |
Condition
Condition
Metabolic syndrome
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the present study is to examine the effectiveness of print reminder on reducing inequality in participation in general health check-up among general population.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Participation rate in general health check-up
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
In the intervention group, the printed reminder is mailed to the participants' house from the insurance association at the end of February, 2017, in order to inform a) they are due for screening, b) needed steps for participation, c) test procedure, d) deadline of participation, and e) the nearest clinics they can undertake the test.
Interventions/Control_2
In the control group, the printed reminder is mailed to the participants' house from the insurance association at the end of February, 2017, in order to inform a) they are due for screening, b) needed steps for participation, c) test procedure, d) deadline of participation, and e) the URL of the website listing all clinics they can undertake the test.
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
| 40 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals selected for inclusion in the health promotion program for improving participation rate in general health check-up meet the following criteria: 1) no record of participation in the general health check-up until December 2016, 2) an age of 40-69 years, and 3) membership in the insurance association as dependents (family member) of insured people.
Key exclusion criteria
The excluded individuals in the present study meet the following criteria: those who receive any special reminder provided by the insurance association.
Target sample size
20000
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Kondo |
Organization
Kyoto University
Division name
Department of Social Epidemiology, Graduate School of Medicine and School of Public Health
Zip code
606-8501
Address
Floor 2, Science Frontier Laboratory, Yoshida-konoe-cho, Sakyo-ku, Kyoto-shi, Kyoto
TEL
075-753-4355
kondo.naoki.0s@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Shimoda |
Organization
The University of Tokyo
Division name
Department of Health and Social Behavior, the School of Public Health
Zip code
113-0033
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3513
Homepage URL
shimoda-tky@umin.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokyo
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-3513
shimoda-tky@umin.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
| 2020 | Year | 11 | Month | 26 | Day |
Related information
URL releasing protocol
http://webpark1166.sakura.ne.jp/wp/
Publication of results
Unpublished
Result
URL related to results and publications
https://www.kyoukaikenpo.or.jp/shibu/fukuoka/
Number of participants that the trial has enrolled
21017
Results
Multivariate logistic regression analysis revealed that intervention was significantly associated with participation in the general health check-up as well as other variables. Interaction term of intervention and income category was also significantly associated with participation, suggesting the heterogeneity of intervention effect across income categories.
Results date posted
| 2020 | Year | 11 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Our participants mainly consisted of female (91.3% and 91.0% in intervention group and control group, respectively). Mean age was approximately 55.1-55.3. For participation in general health check-up. There were no significant differences in any of these variables between the groups.
Participant flow
In February 2017, 21,017 individuals were identified as participants who met the eligibility criteria stated above. Those participants were randomly assigned either intervention group or control group. Then, at the end of February 2017, the association mailed printed reminders to each participant. After 1 month follow-up, we made a comparison of participation rate of general health check-up for each group.
Adverse events
None.
Outcome measures
Participation rates in general health check-up after 1 month of the intervention were significantly different between the groups. When stratified by income category, the difference in participation rate were statistically significant except for the highest income category.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2017 | 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
| 2020 | Year | 11 | Month | 20 | Day |
Last modified on
| 2021 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048485
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