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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.
Gnanenthiran, Sonali R; Tan, Isabella; Atkins, Emily R; Avolio, Alberto; Bennett, Belinda; Chapman, Niamh; Chow, Clara K; Freed, Ruth; Gnjidic, Danijela; Hespe, Charlotte; Kaur, Baldeep; Liu, Huei Ming; Patel, Anushka; Peiris, David; Reid, Christopher M; Schlaich, Markus; Sharman, James E; Stergiou, George S; Usherwood, Tim; Gianacas, Christopher; Rodgers, Anthony; Schutte, Aletta E.
Afiliación
  • Gnanenthiran SR; 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.
  • Tan I; Cardiovascular Division, The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia; Macquarie Medical School, Macquarie University, Sydney, NSW, Australia.
  • Atkins ER; 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.
  • Avolio A; Macquarie Medical School, Macquarie University, Sydney, NSW, Australia.
  • Bennett B; Cardiovascular Division, The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.
  • Chapman N; University of Tasmania, Menzies Institute for Medical Research, Hobart, Australia.
  • Chow CK; Department of Cardiology, Westmead Applied Research Centre, Faculty of Medicine and Health, University of Sydney, Westmead Hospital, Westmead, NSW, Australia.
  • Freed R; Cardiovascular Division, The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.
  • Gnjidic D; School of Pharmacy, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
  • Hespe C; The University of Notre Dame Australia, Sydney, NSW, Australia.
  • Kaur B; Cardiovascular Division, The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.
  • Liu HM; 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.
  • Patel A; Cardiovascular Division, The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.
  • Peiris D; Cardiovascular Division, The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.
  • Reid CM; School of Population Health, Curtin University, Perth, Australia.
  • Schlaich M; Dobney Hypertension Centre, Medical School, Royal Perth Hospital Unit, University of Western Australia, Perth, Australia.
  • Sharman JE; University of Tasmania, Menzies Institute for Medical Research, Hobart, Australia.
  • Stergiou GS; Third Department of Medicine, Hypertension Center STRIDE-7, School of Medicine, Sotiria Hospital, National and Kapodistrian University of Athens, Athens, Greece.
  • Usherwood T; 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.
  • Gianacas C; 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.
  • Rodgers A; Cardiovascular Division, The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.
  • Schutte AE; 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.
Am Heart J ; 265: 50-58, 2023 11.
Article en En | MEDLINE | ID: mdl-37479162
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.
Asunto(s)

Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Dispositivos Electrónicos Vestibles / Hipertensión Tipo de estudio: Clinical_trials / Prognostic_studies / Risk_factors_studies Límite: Adult / Humans Idioma: En Revista: Am Heart J Año: 2023 Tipo del documento: Article País de afiliación: Australia

Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Dispositivos Electrónicos Vestibles / Hipertensión Tipo de estudio: Clinical_trials / Prognostic_studies / Risk_factors_studies Límite: Adult / Humans Idioma: En Revista: Am Heart J Año: 2023 Tipo del documento: Article País de afiliación: Australia