Key result
NEXTGEN-BP tests if a wearable BP monitor strategy lowers clinic systolic BP versus usual care.
Why the study?
Only 1 in 3 patients achieve target blood pressure control, driven by clinical inertia and uncertainties in relying on clinic blood pressure measurements for treatment decisions.
Does a wearable blood pressure monitor-based remote care strategy reduce clinic systolic blood pressure in adults with high blood pressure compared to usual care?
RCT (n=600)
Open-label
1:1
Yes
Does a wearable blood pressure monitor-based remote care strategy reduce clinic systolic blood pressure in adults with high blood pressure compared to usual care?
The NEXTGEN-BP trial will evaluate whether a remote decision support strategy using a wearable cuffless blood pressure monitor improves clinic systolic blood pressure control compared to usual care.
Answers are grounded in this paper and cite their sources.
May guide wearable integration into hypertension care; RCT extends observational data with randomized remote strategy evaluation.
BACKGROUND: Despite high blood pressure being the leading preventable risk factor for death, only 1 in 3 patients achieve target blood pressure control. Key contributors to this problem are clinical inertia and uncertainties in relying on clinic blood pressure measurements to make treatment decisions. METHODS: The NEXTGEN-BP open-label, multicenter, randomized controlled trial will investigate the efficacy, safety, acceptability and cost-effectiveness of a wearable blood pressure monitor-based care strategy for the treatment of hypertension, compared to usual care, in lowering clinic blood pressure over 12 months. NEXTGEN-BP will enroll 600 adults with high blood pressure, treated with 0 to 2 antihypertensive medications. Participants attending primary care practices in Australia will be randomized 1:1 to the intervention of a wearable-based remote care strategy or to usual care. Participants in the intervention arm will undergo continuous blood pressure monitoring using a wrist-wearable cuffless device (Aktiia, Switzerland) and participate in 2 telehealth consultations with their primary care practitioner (general practitioner [GP]) at months 1 and 2. Antihypertensive medication will be up-titrated by the primary care practitioner at the time of telehealth consults should the percentage of daytime blood pressure at target over the past week be <90%, if clinically tolerated. Participants in the usual care arm will have primary care consultations according to usual practice. The primary outcome is the difference between intervention and control in change in clinic systolic blood pressure from baseline to 12 months. Secondary outcomes will be assessed at month 3 and month 12, and include acceptability to patients and practitioners, cost-effectiveness, safety, medication adherence and patient engagement. CONCLUSIONS: NEXTGEN-BP will provide evidence for the effectiveness and safety of a new paradigm of wearable cuffless monitoring in the management of high blood pressure in primary care. TRIAL REGISTRATION: ACTRN12622001583730.
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Gnanenthiran et al. (2023) conducted an RCT in Hypertension (n=600). Wearable blood pressure monitor-based care strategy vs. Usual care was evaluated on Difference between intervention and control in change in clinic systolic blood pressure from baseline to 12 months. The NEXTGEN-BP randomized trial will evaluate whether a wearable blood pressure monitor-based care strategy lowers clinic systolic blood pressure over 12 months compared to usual care in 600 adults.
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