UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045248 |
|---|---|
| Receipt number | R000051581 |
| Scientific Title | Can the vascular age test contribute to increasing the uptake of health checkups in the community? (Shimotsuke community-based empirical study.) |
| Date of disclosure of the study information | 2021/08/25 |
| Last modified on | 2022/02/23 17:34:47 |
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Basic information
Public title
Can the vascular age test contribute to increasing the uptake of health checkups in the community? (Shimotsuke Yasashii-Mirai Community Medicine Project.)
Acronym
Can the vascular age test contribute to increasing the uptake of health checkups in the community? (Shimotsuke Yasashii-Mirai Community Medicine Project.)
Scientific Title
Can the vascular age test contribute to increasing the uptake of health checkups in the community? (Shimotsuke community-based empirical study.)
Scientific Title:Acronym
Can the vascular age test contribute to increasing the uptake of health checkups in the community? (Shimotsuke community-based empirical study.)
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will examine whether the addition of the CAVI test and the feedback of the vascular age on the regular health checkups contributes to improving the rate of uptake of subsequent health checkups.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difference in the participation rate of specific health guidance after health checkups and the participation rate of health checkups in the following year depending on whether subjects take the CAVI test or not.
Key secondary outcomes
A) Changes in CAVI tests results over time and their factors.
B) Relationship between initial CAVI and blood pressure values and subsequent development of cardiovascular disease (diagnosis of hypertension, cardiac hypertrophy, atrial fibrillation, peripheral artery disease, heart failure, and others).
C) Relationship between the initial CAVI value and the rate of patients requiring further examination and treatment.
D) Relationship between the initial CAVI value and the participation rate in the specific health guidance and the rate of health checkups in the following year.
E) Comparison of the background of subjects with and without CAVI
F) Differences in the results of health examinations in the following and subsequent years depending on whether the subjects take CAVI tests or not.
G) Level of involvement of information on vascular health in motivating people to undergo health checkups and seek medical care.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
To the intervention group, we will provide the CAVI tests and results of the vascular age for free to the subjects who undergo residential health checkups and give us their consent. Given that will encourage them to take the health checkups in the following year.
Interventions/Control_2
The subjects in the control group will undergo residential health checkups without consent for the CAVI tests. No interventions. (Opt-out)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects who have undergone lifestyle health checkups (National Health Insurance subscribers), health checkups for the elderly aged 75 or over, or young health checkups in Shimotsuke City (Tochigi) between August 1, 2021, and March 31, 2025.
Those who have obtained consent for CAVI testing will be applied to the intervention group.
Key exclusion criteria
Anyone who falls under any of the following exclusion criteria:
A) Those who have difficulty in obtaining informed consent from the patient.
B) Patients diagnosed by a physician as at least one of the following three conditions; 1) bleeding tendency, 2) thrombogenic tendency due to blood stasis, or 3) peripheral circulatory disturbance due to blood stasis.
C) Subjects with pyogenic skin disease, inflammation, or injury at the cuff attachment site of the CAVI test.
Target sample size
3240
Research contact person
Name of lead principal investigator
| 1st name | Kazuomi |
| Middle name | |
| Last name | Kario |
Organization
Jichi Medical University
Division name
Division of Cardiovascular Medicine /Community Medicine Cardiovascular Asia IT Network Center
Zip code
329-0498
Address
3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, JAPAN
TEL
0285-44-2130
kkario@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Kazuomi |
| Middle name | |
| Last name | Kario |
Organization
Jichi Medical University
Division name
Division of Cardiovascular Medicine /Community Medicine Cardiovascular Asia IT Network Center
Zip code
329-0498
Address
3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, JAPAN
TEL
0285-44-2130
Homepage URL
kkario@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University, Division of Cardiovascular Medicine / Community Medicine Cardiovascular Asia IT Network Center
Institute
Department
Personal name
Funding Source
Organization
Jichi Medical University, Division of Cardiovascular Medicine / Community Medicine Cardiovascular Asia IT Network Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shimotsuke City
Name of secondary funder(s)
Fukuda DenshiCo., LTD.
IRB Contact (For public release)
Organization
Jichi Medical University Clinical Research Ethics Committee
Address
3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, JAPAN
Tel
0285-58-8933
rinri@jichi.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
| 2021 | Year | 08 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2026 | 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
| 2021 | Year | 08 | Month | 24 | Day |
Last modified on
| 2022 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051581
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