Unique ID issued by UMIN | UMIN000014012 |
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Receipt number | R000016107 |
Scientific Title | Japan Trial in High-risk Individuals to Accelerate their Referral to Physicians: A Nurse-led, Community-based Prevention Program of Lifestyle-related Disease |
Date of disclosure of the study information | 2014/05/20 |
Last modified on | 2022/03/16 15:23:57 |
Japan Trial in High-risk Individuals to Accelerate their Referral to Physicians: A Nurse-led, Community-based Prevention Program of Lifestyle-related Disease
J-HARP
Japan Trial in High-risk Individuals to Accelerate their Referral to Physicians: A Nurse-led, Community-based Prevention Program of Lifestyle-related Disease
J-HARP
Japan |
Hypertension, diabetes mellitus, dyslipidemia, and/or chronic kidney disease
Medicine in general |
Others
NO
To investigate whether intensive health guidance to encourage clinical visits will reduce risks of hospitalization and deaths related to stroke, ischemic heart disease, heart failure, and renal failure and dialysis initiation in high-risk individuals without clinical visits.
Efficacy
1. Clinical visit
2. Cumulative incidence of composite outcomes associated with lifestyle-related diseases (the hospitalization related to stroke, myocardial infarction, unstable angina pectoris, heart failure, and dialysis initiation related to chronic renal disease and renal faillure, and deaths from accute cardiac events, cardiovascular disease, chronic renal disease, and renal failure)
1. Continued clinical visits
2. Continued participation in Specific Health Checkups
3. Results of health checkups associated with lifestyle-related disease
4. Age at dialysis initiation
5. Annual overall medical expenditure (inpatient and outpatient) per subject
6. Interruption of health guidance
Interventional
Parallel
Randomized
Open -no one is blinded
Active
2
Prevention
Behavior,custom |
Heath guidance to encourage clinical visits
Conventional health guidance
40 | years-old | <= |
74 | years-old | >= |
Male and Female
1. Covered by National Health Insurance
2. Participating in Specific Health Checkups held as the mass screening
3. Meeting at least one of the following criteria:
- systolic blood pressure >= 160 mmHg and/or dyastolic blood pressure >= 100 mmHg
- Hemoglobin A1c (NGSP) >= 7.0% (if hemoglobin A1c levels are missing, fasting glucose levels >= 130mg/dl; if fasting glucose levels are also missing, casual glucose levels >= 180 mg/dl)
- low-density lipoprotein cholesterol levels >= 180 mg/dl in males
- Proteinuria >= 2+
4. Without clinical visits for hypertension, diabetes mellitus, dyslipidemia, and/or proteinurea
Having difficulty in receiving health guidance due to cognitive impairments, other psychiatric disorders, hearing and visual impairments, and other reasons.
18400
1st name | |
Middle name | |
Last name | Hiroyasu Iso |
Osaka University Graduate School of Medicine
Public Health
2-2 yamadaoka, Suita, Osaka 565-0871, Japan
06-6879-3912
iso@pbhel.med.osaka-u.ac.jp
1st name | |
Middle name | |
Last name | Mitsuyoshi Takahara |
Osaka University Graduate School of Medicine
Metabolic Medicine
2-2 yamadaoka, Suita, Osaka 565-0871, Japan
06-6879-3743
takahara@endmet.med.osaka-u.ac.jp
Osaka University
Ministry of Health, Labour and Welfare
NO
2014 | Year | 05 | Month | 20 | Day |
Partially published
http://www.pbhel.med.osaka-u.ac.jp/themes/j-harp.html
Completed
2014 | Year | 04 | Month | 07 | Day |
2013 | Year | 11 | Month | 14 | Day |
2014 | Year | 05 | Month | 20 | Day |
2016 | Year | 03 | Month | 31 | Day |
2016 | Year | 10 | Month | 27 | Day |
2016 | Year | 10 | Month | 27 | Day |
2025 | Year | 03 | Month | 31 | Day |
2014 | Year | 05 | Month | 20 | Day |
2022 | Year | 03 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016107
Research Plan | |
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Research case data | |
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