UMIN-CTR Clinical Trial

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	https://jpnsh.jp/com_ac_wg2.html
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	http://www.jpnsh.jp/files/cms/637_1.pdf
Publication of results	Partially published

Result
URL related to results and publications	https://www.nature.com/articles/s41440-019-0287-6
Number of participants that the trial has enrolled	308
Results	Correlation coefficients were </=0.16 for the comparison of unattended office blood pressure (UBP) versus home BP for the systolic measurement. The difference between UBP minus home BP was small on average but varied among individuals. In contrast, the measurement values of conventional attended office BP and UBP were highly correlated (r >/= 0.72), but the difference between attended BP minus UBP was 10.4/4.2 mmHg. UBP cannot be used as an alternative to home BP.
Results date posted	2021 Year 09 Month 29 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	(See the publication)
Participant flow	(See the publication)
Adverse events	N/A
Outcome measures	(See the publication)
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
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	2022 Year 04 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030606