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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026721
Receipt No. R000030606
Scientific Title The association between conventional clinic, home, and automated office blood pressures: a pilot study on Japanese patients with hypertension.
Date of disclosure of the study information 2017/04/01
Last modified on 2019/03/29

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Basic information
Public title The association between conventional clinic, home, and automated office blood pressures: a pilot study on Japanese patients with hypertension.
Acronym Pilot study on automated blood pressure measurement among Japanese patients with hypertension.
Scientific Title The association between conventional clinic, home, and automated office blood pressures: a pilot study on Japanese patients with hypertension.
Scientific Title:Acronym Pilot study on automated blood pressure measurement among Japanese patients with hypertension.
Region
Japan

Condition
Condition Essential hypertension
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Association between automated office, self-measured home, and conventional office blood pressure measurements.
Basic objectives2 Others
Basic objectives -Others Comparison of reproducibility, feasibility, and clinical usefulness of each blood pressure measurement.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Relationship between automated office blood pressure and home blood pressure, such as difference, correlation, and associated factors of blood pressure information.
Key secondary outcomes 1) Relationship between automated office blood pressure (AOBP) and conventional office blood pressure.
2) Reproducibility of AOBP.
3) Reproducibility of the association between AOBP and home blood pressure.
4) Reproducibility of the association between AOBP and conventional office blood pressure.
5) Heart rate associated with blood pressure information.
6) Rates on consent and withdrawal of consent with reasons.
7) Practical issues which may be raised from each study center.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
50 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with hypertension.
Patients who can measure and record their blood pressure at home by themselves regularly.
Key exclusion criteria Declined to participate in the study.
Considered not to be eligible judged by study doctors.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Takayoshi
Middle name
Last name Ohkubo
Organization Teikyo University School of Medicine
Division name Department of Hygiene and Public Health
Zip code 173-8605
Address 2-11-1 Kaga, Itabashi-ku, Tokyo 173-8605, Japan
TEL +81-3-3964-3615
Email tohkubo@med.teikyo-u.ac.jp

Public contact
Name of contact person
1st name KEI
Middle name
Last name ASAYAMA
Organization Teikyo University School of Medicine
Division name Department of Hygiene and Public Health
Zip code 173-8605
Address 2-11-1 Kaga, Itabashi-ku, Tokyo 173-8605, Japan
TEL +81-3-3964-3615
Homepage URL http://jpnsh.jp
Email kei@asayama.org

Sponsor
Institute SPRINT-J Working Group, the Japanese Society of Hypertension.
Institute
Department

Funding Source
Organization SPRINT-J Working Group, the Japanese Society of Hypertension.
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization University of the Ryukyus
Address 207 Uehara, Nishihara-cho, Okinawa 903-0215, Japan
Tel +81-98-895-1509
Email yikehara@med.u-ryukyu.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 宮川内科小児科医院 (横浜市保土ヶ谷区)、横浜相鉄ビル内科医院 (横浜市西区)、勝谷医院 (兵庫県尼崎市)

Other administrative information
Date of disclosure of the study information
2017 Year 04 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 308
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
2017 Year 02 Month 19 Day
Date of IRB
2017 Year 02 Month 02 Day
Anticipated trial start date
2017 Year 03 Month 14 Day
Last follow-up date
2019 Year 10 Month 31 Day
Date of closure to data entry
2019 Year 10 Month 31 Day
Date trial data considered complete
2019 Year 12 Month 31 Day
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information Observational study of patients with hypertension. We will collect conventional office, automated office, and home blood pressure as well as accompanying clinical information.

Management information
Registered date
2017 Year 03 Month 27 Day
Last modified on
2019 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030606

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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