Randomized controlled study based on home blood pressure telemonitoring vs. conventional management in a remote island in Japan

Randomized controlled study based on home blood pressure telemonitoring vs. conventional management in a remote island in Japan - Randomized controlled study based on home blood pressure telemonitoring vs. conventional management in a remote island in Japan

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014203

Enrollment

Registered

2014-06-08

Start date

2013-08-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hypertension

Interventions

Patients used BP monitors with a telemonitoring system that stored and transmitted data to a secure website (HEM-7251G) . Patients used conventional BP monitors (HEM-7080IC).

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

—

Secondary

Measure	Time frame
We compared the changes in ankle brachial index (ABI), brachial ankle pulse wave velocity (baPWV), and urine albumin creatinine ratio (UACR) between the groups.	—

Countries

Japan

Contacts

Public ContactEguchi Kazuo

Department of Medicine, Jichi Medical University School of Medicine Division of Cardiovascular Medicine

ke112@jichi.ac.jp0285-58-7344

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026