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
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. The NEXTG...
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Veröffentlicht in: | The American heart journal 2023-11, Vol.265, p.50-58 |
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creator | 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 |
description | 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.
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 |
doi_str_mv | 10.1016/j.ahj.2023.07.005 |
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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.
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.
ACTRN12622001583730.</description><identifier>ISSN: 0002-8703</identifier><identifier>EISSN: 1097-6744</identifier><identifier>DOI: 10.1016/j.ahj.2023.07.005</identifier><identifier>PMID: 37479162</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Acceptability ; Antihypertensives ; Automation ; Blood pressure ; Consent ; Cost analysis ; Decision making ; Effectiveness ; Family physicians ; Hypertension ; Medical equipment ; Monitoring ; Patients ; Primary care ; Risk factors ; Safety ; Strategy ; Telemedicine ; Wearable technology ; Wrist</subject><ispartof>The American heart journal, 2023-11, Vol.265, p.50-58</ispartof><rights>2023 The Authors</rights><rights>Copyright © 2023. Published by Elsevier Inc.</rights><rights>2023. The Authors</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c424t-fb505329c3e48c73281cb71e0e1d4538b86438b8c3562caf11b62dbac9c57e833</citedby><cites>FETCH-LOGICAL-c424t-fb505329c3e48c73281cb71e0e1d4538b86438b8c3562caf11b62dbac9c57e833</cites><orcidid>0000-0003-4145-6461</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/2875375025?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,780,784,3548,27923,27924,45994,64384,64386,64388,72240</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37479162$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Gnanenthiran, Sonali R</creatorcontrib><creatorcontrib>Tan, Isabella</creatorcontrib><creatorcontrib>Atkins, Emily R</creatorcontrib><creatorcontrib>Avolio, Alberto</creatorcontrib><creatorcontrib>Bennett, Belinda</creatorcontrib><creatorcontrib>Chapman, Niamh</creatorcontrib><creatorcontrib>Chow, Clara K</creatorcontrib><creatorcontrib>Freed, Ruth</creatorcontrib><creatorcontrib>Gnjidic, Danijela</creatorcontrib><creatorcontrib>Hespe, Charlotte</creatorcontrib><creatorcontrib>Kaur, Baldeep</creatorcontrib><creatorcontrib>Liu, Huei Ming</creatorcontrib><creatorcontrib>Patel, Anushka</creatorcontrib><creatorcontrib>Peiris, David</creatorcontrib><creatorcontrib>Reid, Christopher M</creatorcontrib><creatorcontrib>Schlaich, Markus</creatorcontrib><creatorcontrib>Sharman, James E.</creatorcontrib><creatorcontrib>Stergiou, George S.</creatorcontrib><creatorcontrib>Usherwood, Tim</creatorcontrib><creatorcontrib>Gianacas, Christopher</creatorcontrib><creatorcontrib>Rodgers, Anthony</creatorcontrib><creatorcontrib>Schutte, Aletta E</creatorcontrib><title>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</title><title>The American heart journal</title><addtitle>Am Heart J</addtitle><description>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.
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.
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.
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wearable blood pressure monitoring: The NEXTGEN-BP randomized trial protocol</atitle><jtitle>The American heart journal</jtitle><addtitle>Am Heart J</addtitle><date>2023-11-01</date><risdate>2023</risdate><volume>265</volume><spage>50</spage><epage>58</epage><pages>50-58</pages><issn>0002-8703</issn><eissn>1097-6744</eissn><abstract>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.
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.
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.
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subjects | Acceptability Antihypertensives Automation Blood pressure Consent Cost analysis Decision making Effectiveness Family physicians Hypertension Medical equipment Monitoring Patients Primary care Risk factors Safety Strategy Telemedicine Wearable technology Wrist |
title | 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 |
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