Tokyo, Dec. 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060224) titled 'Effect of Home Blood Pressure Monitoring Using a Smartphone-Connected Device and Lifestyle on Blood Pressure Control' on Dec. 29.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Iwate Medical University

Condition: Condition - Eligible participants are workers who were identified as having elevated blood pressure at routine workplace health checkups Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aimed to examine the effectiveness of smartphone-connected home blood pressure monitoring and guideline-based hypertension management in improving lifestyle behaviors, lowering blood pressure, and increasing antihypertensive medication use among workers with hypertension detected at workplace health checkups. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Workers with a systolic blood pressure of >=140 mmHg and/or a diastolic blood pressure of >=90 mmHg at routine workplace health checkups were allocated to either an intervention group or a control group using stratified randomization based on sex, age, and systolic blood pressure level.

Participants assigned to the intervention group performed home blood pressure monitoring using a smartphone application-connected, communication-enabled blood pressure device twice daily (after waking and before bedtime) for 14 consecutive days, followed by initial lifestyle counseling based on a hypertension management plan using the home blood pressure results; home blood pressure was re-evaluated and additional counseling was provided three months later. Interventions/Control_2 - Participants in the control group did not receive home blood pressure monitoring; instead, they received initial lifestyle counseling based on blood pressure measured at the workplace health checkup according to the hypertension management plan, followed by re-evaluation using casual blood pressure measurement and additional counseling three months later.

Eligibility: Age-lower limit - Not applicable Age-upper limit - 75 years-old > Gender - Male and Female Key inclusion criteria - Workers with a systolic blood pressure of >=140 mmHg and/or a diastolic blood pressure of >=90 mmHg identified at routine workplace health checkups. Key exclusion criteria - Individuals who routinely measure and record home blood pressure

Individuals who are not scheduled to undergo the routine workplace health checkup in the year following the intervention

Individuals for whom blood pressure reduction is medically contraindicated or restricted by a physician Target Size - 72

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2022 Year 12 Month 09 Day Date of IRB - 2022 Year 12 Month 09 Day Anticipated trial start date - 2023 Year 04 Month 01 Day Last follow-up date - 2025 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068768

Disclaimer: Curated by HT Syndication.