UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026721 |
|---|---|
| Receipt number | 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 | 2022/04/04 18:22:02 |
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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
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
kei@asayama.org
Sponsor or person
Institute
SPRINT-J Working Group, the Japanese Society of Hypertension.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030606
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