Transforming blood pressure control in primary care through a novel remote decision support strategy based on wearable blood pressure monitoring: The NEXTGEN-BP randomized trial protocol

Sonali R Gnanenthiran; Isabella Tan; Emily R Atkins; Alberto Avolio; Belinda Bennett; Niamh Chapman; Clara K Chow; Ruth Freed; Danijela Gnjidic; Charlotte Hespe; Baldeep Kaur; Huei Ming Liu; Anushka Patel; David Peiris; Christopher M Reid; Markus Schlaich; James E Sharman; George S Stergiou; Tim Usherwood; Christopher Gianacas; Anthony Rodgers; Aletta E Schutte

doi:10.1016/j.ahj.2023.07.005

Transforming blood pressure control in primary care through a novel remote decision support strategy based on wearable blood pressure monitoring: The NEXTGEN-BP randomized trial protocol

Am Heart J. 2023 Nov:265:50-58. doi: 10.1016/j.ahj.2023.07.005. Epub 2023 Jul 20.

Authors

Sonali R Gnanenthiran¹, Isabella Tan², Emily R Atkins³, Alberto Avolio⁴, Belinda Bennett⁵, Niamh Chapman⁶, Clara K Chow⁷, Ruth Freed⁵, Danijela Gnjidic⁸, Charlotte Hespe⁹, Baldeep Kaur⁵, Huei Ming Liu¹⁰, Anushka Patel⁵, David Peiris⁵, Christopher M Reid¹¹, Markus Schlaich¹², James E Sharman⁶, George S Stergiou¹³, Tim Usherwood³, Christopher Gianacas¹⁴, Anthony Rodgers⁵, Aletta E Schutte¹⁵

Affiliations

¹ Cardiovascular Division, The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia; Cardiology Department, Concord Repatriation General Hospital, Sydney, NSW, Australia.
² Cardiovascular Division, The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia; Macquarie Medical School, Macquarie University, Sydney, NSW, Australia.
³ Cardiovascular Division, The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia; Department of Cardiology, Westmead Applied Research Centre, Faculty of Medicine and Health, University of Sydney, Westmead Hospital, Westmead, NSW, Australia.
⁴ Macquarie Medical School, Macquarie University, Sydney, NSW, Australia.
⁵ Cardiovascular Division, The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.
⁶ University of Tasmania, Menzies Institute for Medical Research, Hobart, Australia.
⁷ Department of Cardiology, Westmead Applied Research Centre, Faculty of Medicine and Health, University of Sydney, Westmead Hospital, Westmead, NSW, Australia.
⁸ School of Pharmacy, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
⁹ The University of Notre Dame Australia, Sydney, NSW, Australia.
¹⁰ Cardiovascular Division, The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia; Menzies Centre for Health Policy and Economics, University of Sydney, Sydney, NSW, Australia.
¹¹ School of Population Health, Curtin University, Perth, Australia.
¹² Dobney Hypertension Centre, Medical School, Royal Perth Hospital Unit, University of Western Australia, Perth, Australia.
¹³ Third Department of Medicine, Hypertension Center STRIDE-7, School of Medicine, Sotiria Hospital, National and Kapodistrian University of Athens, Athens, Greece.
¹⁴ Cardiovascular Division, The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia; School of Population Health, UNSW Sydney, Sydney, NSW, Australia.
¹⁵ Cardiovascular Division, The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia; School of Population Health, UNSW Sydney, Sydney, NSW, Australia. Electronic address: a.schutte@unsw.edu.au.

PMID: 37479162
DOI: 10.1016/j.ahj.2023.07.005

Abstract

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.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Antihypertensive Agents / therapeutic use
Blood Pressure / physiology
Humans
Hypertension* / diagnosis
Hypertension* / drug therapy
Multicenter Studies as Topic
Primary Health Care / methods
Randomized Controlled Trials as Topic
Wearable Electronic Devices*

Substances

Antihypertensive Agents

Associated data

ANZCTR/ACTRN12622001583730