UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024692 |
|---|---|
| Receipt number | R000027878 |
| Scientific Title | Intervention trial for determining recommendation effects of explaining detailed information regarding future cardiovascular risks on rate of visiting medical facilities for those who were found to have chronic diseases in medical check-up |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2024/05/08 23:18:13 |
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Basic information
Public title
Intervention trial for determining recommendation effects of explaining detailed information regarding future cardiovascular risks on rate of visiting medical facilities for those who were found to have chronic diseases in medical check-up
Acronym
Next 10
Scientific Title
Intervention trial for determining recommendation effects of explaining detailed information regarding future cardiovascular risks on rate of visiting medical facilities for those who were found to have chronic diseases in medical check-up
Scientific Title:Acronym
Next 10
Region
| Japan |
Condition
Condition
Noncommunicable Diseases
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
tarnslation-in-progress
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Improvement of weight, blood pressure, lipid, and glucose data after 1 year in the following subjects
1. NIPPON DATA: Patients who have a "probability of death from cardiovascular disease within 10 years: 7-15% or more
2. Patients who meet the following conditions based on the comprehensive risk management chart: "Step 1c: Determination of the need for referral to a specialist, etc." (a) Hypertension
a. Hypertension*: Grade II hypertension (systolic blood pressure 160 mmHg, or diastolic blood pressure 100 mmHg)
b. Diabetes mellitus: HbA1c 6.5%*, fasting blood glucose 126mg/dL, or anytime blood glucose 200mg/dL)
c. Dyslipidemia: LDL-C 180mg/dL, HDL-C 30mg/dL, fasting TG 500mg/dL, nonHDL-C 210mg/dL,
d. Chronic kidney disease: severe proteinuria (2+ by the paper method), both proteinuria and hematuria positive (1+ by the paper method), eGFR 50mL/min/1.73m2 (60 in patients 40 years old, 40 in patients 70 years old with stable renal function)
e. Obesity: severe obesity (BMI 35)
Key secondary outcomes
Ratio of antihypertensive, antidiabetic, and antidyslipidemic drug use after 1 year
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
(a) Selection of examinees who fit the selection policy for research subjects.
(b) In addition to the usual notification of the results of the medical checkups, send a letter notifying them that they are eligible for the current study.
(c) The letter should also include a letter of referral that can be brought directly to the medical institution.
(d) The letter of referral should also include a letter of reply for illness and a return envelope, and the doctor should mail it to the research headquarters (the same procedure as for a regular medical checkup).
(e) After 3 months, for those who have not received a response to the letter of referral to the head office, have them confirm through the health manager of the business establishment, etc., that they have been examined, and for those who have not been examined, encourage them to be examined again.
Interventions/Control_2
For the non-intervention group, the Niigata Occupational Health and Medical Association's result notification slip will be used to recommend medical examinations, as in the past.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) NIPPON DATA: Patients who have "Probability of death from cardiovascular disease within 10 years: 7-15% or more
(2) Patients who meet the following conditions according to the comprehensive risk management chart: "Step 1c Determination of the need for referral to a specialist, etc." (a) Hypertension*: Grade II hypertension (systolic blood pressure 160 mmHg)
(a) Hypertension*: Grade II hypertension (systolic blood pressure 160 mmHg, or diastolic blood pressure 100 mmHg)
(b) Diabetes mellitus: HbA1c 6.5%*, fasting blood glucose 126mg/dL, or anytime blood glucose 200mg/dL)
(c) Dyslipidemia: LDL-C 180mg/dL, HDL-C 30mg/dL, fasting TG 500mg/dL, nonHDL-C 210mg/dL,
(d) Chronic kidney disease: severe proteinuria (2+ by the paper method), both proteinuria and hematuria positive (1+ by the paper method), eGFR<50mL/min/1.73m2 (60 in patients 40 years old, 40 in patients 70 years old with stable renal function)
(e) Obesity: severe obesity (BMI 35)
Key exclusion criteria
none
Target sample size
6000
Research contact person
Name of lead principal investigator
| 1st name | Hirohito |
| Middle name | |
| Last name | Sone |
Organization
Niigata University Faculty of Medicine
Division name
Department of Hematology, Endocrinology and Metabolism
Zip code
951-8510
Address
1-757 Asahimachi-dori Chuoh-ku Niigata, Japan 951-8510
TEL
+81-25-368-9024
sone@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Kiminori |
| Middle name | |
| Last name | Kato |
Organization
Graduate School of Medical and Dental Sciences Niigata University
Division name
Department of Laboratory Medicine and Clinical Epidemiology for Prevention of Noncommunicable Diseas
Zip code
951-8510
Address
1-757 Asahimachi-dori Chuoh-ku Niigata, Japan 951-8510
TEL
+81-25-227-2117
Homepage URL
kkato48@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University School of Medicine
Address
1-757 Asahimachi-dori Chuoh-ku Niigata, Japan 951-8510
Tel
025-227-2625
ethics@adm.niigata-u.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
| 2016 | Year | 12 | Month | 01 | 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
9365
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2016 | Year | 11 | Month | 02 | Day |
Last modified on
| 2024 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027878
