UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014012
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

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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 or person

Institute

Osaka University

Institute

Department

Personal name



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

2022 Year 03 Month 16 Day



Link to view the page

Value
https://center6.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