TY - JOUR
T1 - Transforming blood pressure control in primary care through a novel remote decision support strategy based on wearable blood pressure monitoring
T2 - the NEXTGEN-BP randomized trial protocol
AU - Gnanenthiran, Sonali R.
AU - Tan, Isabella
AU - Atkins, Emily R.
AU - Avolio, Alberto
AU - Bennett, Belinda
AU - Chapman, Niamh
AU - Chow, Clara K.
AU - Freed, Ruth
AU - Gnjidic, Danijela
AU - Hespe, Charlotte
AU - Kaur, Baldeep
AU - Liu, Huei Ming
AU - Patel, Anushka
AU - Peiris, David
AU - Reid, Christopher M.
AU - Schlaich, Markus
AU - Sharman, James E.
AU - Stergiou, George S.
AU - Usherwood, Tim
AU - Gianacas, Christopher
AU - Rodgers, Anthony
AU - Schutte, Aletta E.
N1 - Copyright the Author(s) 2023. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.
PY - 2023/11
Y1 - 2023/11
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85165633614&partnerID=8YFLogxK
U2 - 10.1016/j.ahj.2023.07.005
DO - 10.1016/j.ahj.2023.07.005
M3 - Article
C2 - 37479162
AN - SCOPUS:85165633614
SN - 0002-8703
VL - 265
SP - 50
EP - 58
JO - American Heart Journal
JF - American Heart Journal
ER -