Key result
New trial protocol evaluates high-intensity versus low-intensity SMBP monitoring for uncontrolled hypertension.
Why the study?
Self-measured blood pressure monitoring improves hypertension control, but implementing it is challenging in safety-net systems serving low-income and racial/ethnic minority populations.
Does a high-intensity implementation strategy for self-measured blood pressure monitoring reduce clinic-measured systolic BP in diverse patients with uncontrolled hypertension compared to a low-intensity strategy?
RCT (n=330)
patient-level
Yes
Does a high-intensity implementation strategy for self-measured blood pressure monitoring reduce clinic-measured systolic BP in diverse patients with uncontrolled hypertension compared to a low-intensity strategy?
This study protocol outlines a trial to evaluate multi-level implementation strategies for increasing self-measured blood pressure monitoring in diverse, low-income populations.
Answers are grounded in this paper and cite their sources.
RCT protocol tests high- versus low-intensity SMBP; leaves open optimal strategy for BP control in diverse, low-income patients.
INTRODUCTION: Self-measured blood pressure (SMBP) monitoring with clinical support is an evidence-based practice to improve hypertension control. However, it can be challenging to implement in safety-net systems that disproportionately serve low-income and/or racial/ethnic minority populations at risk of worse hypertension outcomes. We therefore propose a hybrid effectiveness-implementation trial to evaluate the effectiveness of multi-level implementation strategies to increase the use of SMBP monitoring in two urban safety-net systems. METHODS: We will conduct a patient-level randomized controlled trial with 330 English-, Spanish-, and Chinese (Cantonese)-speaking patients with uncontrolled hypertension across six study sites with patients randomized to a low-intensity (SMBP education, text message education and reminders) vs. high-intensity intervention (adds group classes and engagement of identified caregivers). To support increased use of SMBP data by the clinical team, we will concurrently deliver a staggered roll-out of a clinic-level implementation strategy (clinic education, shadowing, auditing with feedback, and optimization of electronic health record [EHR] use). RESULTS: The primary outcomes will be clinic-measured systolic BP (SBP) among enrolled participants for the patient-level intervention and among all patients assigned to the clinic for the clinic-level intervention. We will additionally collect secondary clinical outcomes (BP control, home SBP), implementation outcomes (adoption, reach, and costs), and patient-reported outcomes (patient activation). DISCUSSION: The results of this trial will address gaps in identifying cost-conscious implementation strategies for increasing adoption of SMBP in safety-net systems with the overarching goal of improving blood pressure control in low-income, diverse patient populations. Trial registration NCT, NCT06871462. Registered 4 March 2025, https://clinicaltrials.gov/study/NCT06871462.
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Khoong et al. (2025) conducted an RCT in uncontrolled hypertension (n=330). High-intensity self-measured blood pressure monitoring intervention vs. Low-intensity intervention was evaluated on Clinic-measured systolic BP. This study protocol outlines a randomized controlled trial of 330 patients to evaluate high-intensity versus low-intensity self-measured blood pressure monitoring for uncontrolled hypertension.
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