UMIN-CTR Clinical Trial

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

hypertension

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

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

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

Institute

Jichi Medical University

Institute

Department

Personal name

Organization

Jichi Medical University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

Date of disclosure of the study information

2014

Year

06

Month

08

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2014

Year

06

Month

07

Day

Last modified on

2014

Year

06

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016538