Mobile App for BP Control

NCT04470284 | Completed

• 1 other identifier: SMART-BP
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• mean home systolic BP change

  mean home systolic BP change from baseline to 24 weeks (Visit 2)

  24 weeks

• Drug adherence

  Drug adherence using pill count

  24 weeks

Secondary Outcomes (2)

• Diastolic BP change

  12 weeks and 24 week

• office BP change

  12 weeks and 24 week

Study Arms (2)

SMBP_only

ACTIVE COMPARATOR

Standard treatment with SMBP

Other: Standard SMBP

SMBP_mobile_app

EXPERIMENTAL

SMBP with mobile App based feed-back algorithm

Other: Mobile Application

Interventions

Mobile Application OTHER

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.

SMBP_mobile_app

Standard SMBP OTHER

Standard treatment (SMBP-alone)

SMBP_only

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients with essential hypertension aged 19 years and above.
• Patients with essential hypertension who are taking one or more antihypertensive drugs.
• Patients whose average systolic and diastolic BP measured 3 times on the reference arm in the sitting position during Visit 1 is greater than 140 mmHg and 90 mmHg, respectively.
• Patients voluntarily consent to participate in this clinical trial
• Patients who can use a smartphone

You may not qualify if:

• Patients with a history of secondary hypertension or suspected secondary hypertension, including coarctation of the aorta, primary hyperaldosteronism, renal artery stenosis, Cushing's syndrome, pheochromocytoma, and polycystic kidney disease.
• Patients with a mean systolic BP ≥ 200 mmHg or diastolic BP ≥ 110 mmHg at the screening visit.
• Patients with ≥ 20 mmHg difference between the highest and the lowest sitting systolic BP or ≥ 10 mmHg difference between highest and lowest diastolic BP, which is confirmed by triplicate measurements from the reference arm at screening.
• Patients with uncontrolled diabetes (HbA1c ≥ 9.0%).
• Patients who have been continuously taking other medications such as systemic steroids, thyroid hormones, oral contraceptives (except for menopausal hormone replacement therapy), psychiatric drugs, non-steroidal anti-inflammatory drugs, sympathetic drugs, and immune suppressants, which have the potential to affect BP.
• Patients with symptomatic orthostatic hypotension.
• Patients with a history of malignant tumors, including leukemia and lymphoma, within the past 5 years.
• Patients with a history of autoimmune diseases, such as rheumatoid arthritis and systemic lupus erythematosus.
• Patients with clinically significant kidney and liver diseases, such as those on dialysis, liver cirrhosis, biliary obstruction, and hepatic failure, or those who show the following findings during the screening visit:
• Alanine transaminase or aspartate transaminase level is at least 3 times higher than the normal upper limit;
• Total bilirubin level is more than twice the normal upper limit;
• Blood urea nitrogen level is more than twice the normal upper limit;
• Alkaline phosphatase level is more than twice the normal upper limit;
• Creatinine clearance level is less than 10 mL/min.
• Patients with a history of the following diseases in the past 6 months, which are determined to be clinically significant by the investigator:

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (5)

Korea Univ. Guro Hospital

Seoul, Guro, 08308, South Korea

Location

Hallym University Sacred Heart Hospital

Anyang, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, 13620, South Korea

Location

Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine

Seoul, South Korea

Location

Kyung Hee University Hospital

Seoul, South Korea

Location

Related Publications (2)

• Yoon M, Hur T, Park SJ, Jo SH, Kim EJ, Kim SJ, Hussain M, Hua CH, Lee S, Choi DJ. Self-Monitoring of Blood Pressure and Feedback via Mobile App in Treatment of Uncontrolled Hypertension: The SMART-BP Randomized Clinical Trial. Mayo Clin Proc. 2025 May;100(5):840-853. doi: 10.1016/j.mayocp.2024.09.018. Epub 2025 Mar 5.

  PMID: 40047759 DERIVED

• Choi DJ, Park JJ, Yoon M, Park SJ, Jo SH, Kim EJ, Kim SJ, Lee S. Self-Monitoring of Blood Pressure and Feed-back Using APP in TReatment of UnconTrolled Hypertension (SMART-BP): A Randomized Clinical Trial. Korean Circ J. 2022 Oct;52(10):785-794. doi: 10.4070/kcj.2022.0133.

  PMID: 36217600 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dong-Ju Choi, MD, PhD

  Seoul National Univeristy Bundang Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 14, 2020
• Study Start: September 1, 2019
• Primary Completion: March 15, 2021
• Study Completion: March 15, 2021
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

KR (5)