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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025411
Receipt No. R000028930
Scientific Title The effect of referral form on hypertension treatment rate in Japanese hypertensive employees: a cluster randomized controlled trial
Date of disclosure of the study information 2017/01/06
Last modified on 2018/12/28

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Basic information
Public title The effect of referral form on hypertension treatment rate in Japanese hypertensive employees: a cluster randomized controlled trial
Acronym The effect of referral form on hypertension treatment rate in Japanese hypertensive employees: a cluster randomized controlled trial
Scientific Title The effect of referral form on hypertension treatment rate in Japanese hypertensive employees: a cluster randomized controlled trial
Scientific Title:Acronym The effect of referral form on hypertension treatment rate in Japanese hypertensive employees: a cluster randomized controlled trial
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Cardiology Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine whether giving a referral form at the annual health checkup improve proportion of patients with hypertension treatment among Japanese hypertensive workers.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Outpatient visit for hypertension after 6 months evaluated by the health insurance claim data.
Key secondary outcomes Blood pressure, frequency of outpatient visit, change of antihypertensive agents after 2 years and additional exploratory analysis.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Recommendation for the treatment of hypertension at the time of the annual health checkup using both the referral form to general practitioners and a leaflet for hypertension control.
Interventions/Control_2 Recommendation for the treatment of hypertension using a leaflet for hypertension control.
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
20 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria 1) Having Grade I hypertension in 2016
2) Having Grade II hypertension in 2017
3) Untreated in 2017
4) Consent to participate in the study
Key exclusion criteria 1) Pregnant in 2016 or 2017
2) Having antihypertension agents in 2017
3) SBP >=190 or DBP >= 120 in 2017


Target sample size 234

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naomi Miyamatsu
Organization Shiga University of Medical Science
Division name Department of Clinical Nursing
Zip code
Address Seta Tsukinowa-cho, Otsu City, Shiga, JAPAN
TEL 077-548-2437
Email shiazusa@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Azusa Shima
Organization Shiga University of Medical Science
Division name Department of Clinical Nursing
Zip code
Address Seta Tsukinowa-cho, Otsu City, Shiga, JAPAN
TEL 077-548-2437
Homepage URL
Email shiazusa@belle.shiga-med.ac.jp

Sponsor
Institute Department of Clinical Nursing, Shiga University of Medical Science
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2017 Year 01 Month 06 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
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 12 Month 06 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 12 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 09 Month 30 Day
Date trial data considered complete
2020 Year 12 Month 31 Day
Date analysis concluded
2021 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 12 Month 26 Day
Last modified on
2018 Year 12 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028930

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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