UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037883 |
|---|---|
| Receipt number | R000043187 |
| Scientific Title | Single-blind randomized parallel group trial on the effect of primary preventive intervention using data envelopment analysis aiming the reduction of the onset of hypertension. |
| Date of disclosure of the study information | 2019/09/02 |
| Last modified on | 2023/07/12 18:12:03 |
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Basic information
Public title
Single-blind randomized parallel group trial on the effect of primary preventive intervention using data envelopment analysis aiming the reduction of the onset of hypertension.
Acronym
Primary preventive interventional study on hypertension using data envelopment analysis.
Scientific Title
Single-blind randomized parallel group trial on the effect of primary preventive intervention using data envelopment analysis aiming the reduction of the onset of hypertension.
Scientific Title:Acronym
Primary preventive interventional study on hypertension using data envelopment analysis.
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general | Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Reducing the rate of onset of hypertension
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Percentage of participants who met one of the following criteria at specific health checkup a year after the study entry: systolic blood pressure 140 mmHg or higher, diastolic blood pressure 90 mmHg or higher, or taking antihypertensive medication.
Key secondary outcomes
Results from the examination at the health checkup; onset rate of cardiovascular diseases, mortality rate, death related to cardiovascular diseases during 5 years from baseline; total medical expense of each individual in 5 years (sum of annual medical expenditure for 5 years after baseline recruitment) and difference of the annual medical expense between the baseline year and each 5 years after baseline recruitment.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Single Notification of risk score and estimated salt intake by post mail
Interventions/Control_2
Control arm (information provision in specific health checkup/specific health guidance); single notification of estimated salt intake by post mail
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Those who receive specific health checkup
2) Those who can express their willingness to participate on their own. Consent by proxy is not accepted.
3) Those who can read, understand, and answer questionnaire.
4) Those who belonged to information provision (one of the specific health guidance groups classified according to the result of specific health check-ups).
Key exclusion criteria
1) Those who are not fluent in Japanese.
2) Those who seemed to be inappropriate to participate in the study due to physical or psychological reasons by the local public health nurse.
3)Those whose blood pressure at the baseline survey was >= 140 mmHg (systolic) and/or >= 90 mmHg.
4) Those who are taking anti-hypertensive medication
5) Those who have a past history of cardiac diseases (angina pectoris and myocardial infarction).
Target sample size
562
Research contact person
Name of lead principal investigator
| 1st name | Hiroto |
| Middle name | |
| Last name | Narimatsu |
Organization
Kanagawa University of Human Services
Division name
Health Innovation Research Course
Zip code
210-0821
Address
RBG-2, 3-25-10, Tonomachi, Kawasaki-ku, Kawasaki, Kanagawa
TEL
+81-(0)44-589-8100
hiroto-narimatsu@umin.org
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Nakamura |
Organization
Kanagawa University of Human Services
Division name
Health Innovation Research Course
Zip code
210-0821
Address
RBG-2, 3-25-10, Tonomachi, Kawasaki-ku, Kawasaki, Kanagawa
TEL
+81-(0)44-589-8100
Homepage URL
sho-nakamura@umin.org
Sponsor or person
Institute
Health Innovation Research Course, Kanagawa University of Human Services
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kanagawa Cancer Center Research Institute
Takahata town, Yamagata, Japan
Takahata Hospital
Plan-makers for the Community Health and Wellbeing, Specified Nonprofit Corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanagawa University of Human Services, Health Innovation Research Course Institutional Review Board
Address
RBG-2, 3-25-10, Tonomachi, Kawasaki-ku, Kawasaki, Kanagawa
Tel
+81-(0)44-589-8100
health-innovation@kuhs.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
高畠町役場 げんき館・健康長寿課・健診センター（山形県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
445
Results
The risk difference for the primary outcome was 0.2% (95% CI -7.3 to 6.9) with 38/218 (17.4%) and 40/227 (17.6%) events in the intervention and control group, respectively (Pearson's chi-square test, p=0.880). The adjusted odds ratio of the effect of the intervention was 0.95 (95% CI 0.56 to 1.61, p=0.843).
Results date posted
| 2023 | Year | 07 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 05 | Month | 04 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
Data will only be shared under certain conditions.
IPD sharing Plan description
The data collected through the study are not publicly available for ethical reasons, but individual deidentified participant data (including data dictionaries) will be available upon approval of the protocols, including the purpose of data sharing (e.g., verification of reproducibility to prevent research misconduct), by the Research Ethics Review Board at the Graduate School of Health Innovation, Kanagawa University of Human Services, and at Takahata Town. We cannot provide the datasets for the purpose of secondary use in research, as consent for such use has not been obtained.
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 02 | 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
| 2019 | Year | 09 | Month | 01 | Day |
Last modified on
| 2023 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043187
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