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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014203
Receipt No. R000016538
Scientific Title Randomized controlled study based on home blood pressure telemonitoring vs. conventional management in a remote island in Japan
Date of disclosure of the study information 2014/06/08
Last modified on 2014/06/07

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Basic information
Public title Randomized controlled study based on home blood pressure telemonitoring vs. conventional management in a remote island in Japan
Acronym Randomized controlled study based on home blood pressure telemonitoring vs. conventional management in a remote island in Japan
Scientific Title Randomized controlled study based on home blood pressure telemonitoring vs. conventional management in a remote island in Japan
Scientific Title:Acronym Randomized controlled study based on home blood pressure telemonitoring vs. conventional management in a remote island in Japan
Region
Japan

Condition
Condition hypertension
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We assessed whether a home BP telemonitoring system could improve BP control and overcome the problems of HBP monitoring in a remote location.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1) the changes in home morning and evening BP before and after treatment; 2) changes in the adherence to the HBP measurement protocol (calculated as the frequency of BP measurements in the latter half of the study (maximum frequency: 28) minus that in the first half (maximum frequency: 28); and 3) the visual analogue scale (VAS) scores as a measure of the motivation to perform HBP measurements (0=worst, 100=best).
Key secondary outcomes We compared the changes in ankle brachial index (ABI), brachial ankle pulse wave velocity (baPWV), and urine albumin creatinine ratio (UACR) between the groups.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Patients used BP monitors with a telemonitoring system that stored and transmitted data to a secure website (HEM-7251G) .
Interventions/Control_2 Patients used conventional BP monitors (HEM-7080IC).
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) diabetes mellitus or impaired glucose metabolism [during treatment or fasting blood glucose >110 mg/dL, 75gOGTT (2h) >140mg/dL]; 2) dyslipidemia (total cholesterol >240mg/dL or the use of lipid-lowering drugs); 3) hypertension (on medication or office SBP >140mmHg or office DBP >90mmHg; 4) current smoking (within 1 year); 5) kidney disease (albuminuria or creatinine >1.1 mg/dL; 6) atrial fibrillation; 7) metabolic syndrome; 8) chronic obstructive pulmonary disease; 9) sleep apnea syndrome.
Key exclusion criteria 1) current residence anywhere other than Niijima (or living off Niijima more than half of the year); 2) ischemic heart disease; 3) stroke (except asymptomatic and transient); 4) aortic dissection; 5) peripheral artery disease; 6) heart failure requiring hospitalization within the past 6 months; 7) hemodialysis; 8) inability to provide informed consent, self-measure BP, or walk; and 9) presence of serious diseases other than those described in the inclusion criteria.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kaihara Toshiki
Organization Niijima-mura National Health Insurance Clinic
Division name Division of internal Medicine
Zip code
Address 4-10-3 Honson, Niijima, Tokyo, Japan
TEL 04992-5-0083
Email m03014tk@jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eguchi Kazuo
Organization Department of Medicine, Jichi Medical University School of Medicine
Division name Division of Cardiovascular Medicine
Zip code
Address 3311-1 Shimotsuke, Tochigi, Japan.
TEL 0285-58-7344
Homepage URL
Email ke112@jichi.ac.jp

Sponsor
Institute Jichi Medical University
Institute
Department

Funding Source
Organization Jichi Medical University
Organization
Division
Category of Funding Organization Other
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 YES
Study ID_1 Clinical category #13-02
Org. issuing International ID_1 Jichi Medical University
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 06 Month 08 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 Completed
Date of protocol fixation
2013 Year 06 Month 07 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 06 Month 07 Day
Last modified on
2014 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016538

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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