SMART-BP is a randomized, controlled study in which hypertensive patients are allocated to self monitoring of blood pressure monitoring (SMBP) only group or SMBP with mobile App based feed-back algorithm (SMBP-App) group. The App based feed-back algorithm will provide the patients with instruction in response to the measured BP value, e.g. remind of taking drug, if high blood pressure is detected. The primary outcomes are mean systolic BP change and drug compliance at 24-weeks. Secondary endpoints include mean diastolic BP change at 12-week, mean systolic and diastolic BP change at 12 and 24 weeks, and drug compliance.
This trial is a prospective, randomized, open-label, multicenter trial to evaluate the efficacy of SMBP with mobile health application (SMBP-App) compared with SMBP alone. Patients with hypertension will be randomly assigned to SMBP-App (intervention) and SMBP along (control) groups. In SMBP group the patients perform home blood pressure measurement and usual care. In SMBP-App group the patients perform home blood pressure and receive extra alarm and instructions from the mobile application in response to the obtained blood pressure value. The aim of this study is to evaluate whether SMBP-App is superior to SMBP alone in terms of blood pressure reduction and improved drug compliance in patients with hypertension.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
186
SMBP with mobile App based feed-back algorithm. The App based feed-back algorithm will remind the patients of taking drug to improve BP control and drug compliance.
Standard treatment (SMBP-alone)
Korea Univ. Guro Hospital
Seoul, Guro, South Korea
Hallym University Sacred Heart Hospital
Anyang, South Korea
Seoul National University Bundang Hospital
Seongnam, South Korea
Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, South Korea
mean home systolic BP change
mean home systolic BP change from baseline to 24 weeks (Visit 2)
Time frame: 24 weeks
Drug adherence
Drug adherence using pill count
Time frame: 24 weeks
Diastolic BP change
mean home diastolic BP change from baseline
Time frame: 12 weeks and 24 week
office BP change
office systolic or diastolic BP change from baseline
Time frame: 12 weeks and 24 week
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Kyung Hee University Hospital
Seoul, South Korea