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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014012
Receipt No. 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 2020/02/26

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Basic information
Public title Japan Trial in High-risk Individuals to Accelerate their Referral to Physicians: A Nurse-led, Community-based Prevention Program of Lifestyle-related Disease
Acronym J-HARP
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
Scientific Title:Acronym J-HARP
Region
Japan

Condition
Condition Hypertension, diabetes mellitus, dyslipidemia, and/or chronic kidney disease
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 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)
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Heath guidance to encourage clinical visits
Interventions/Control_2 Conventional health guidance
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
74 years-old >=
Gender Male and Female
Key inclusion criteria 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
Key exclusion criteria Having difficulty in receiving health guidance due to cognitive impairments, other psychiatric disorders, hearing and visual impairments, and other reasons.
Target sample size 18400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyasu Iso
Organization Osaka University Graduate School of Medicine
Division name Public Health
Zip code
Address 2-2 yamadaoka, Suita, Osaka 565-0871, Japan
TEL 06-6879-3912
Email iso@pbhel.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuyoshi Takahara
Organization Osaka University Graduate School of Medicine
Division name Metabolic Medicine
Zip code
Address 2-2 yamadaoka, Suita, Osaka 565-0871, Japan
TEL 06-6879-3743
Homepage URL
Email takahara@endmet.med.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2014 Year 05 Month 20 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications http://www.pbhel.med.osaka-u.ac.jp/themes/j-harp.html
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 Completed
Date of protocol fixation
2014 Year 04 Month 07 Day
Date of IRB
2013 Year 11 Month 14 Day
Anticipated trial start date
2014 Year 05 Month 20 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 10 Month 27 Day
Date trial data considered complete
2016 Year 10 Month 27 Day
Date analysis concluded
2025 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 05 Month 20 Day
Last modified on
2020 Year 02 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016107

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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