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Home and Online Management and Evaluation of Blood Pressure (HOME BP) using a digital intervention in poorly controlled hypertension: randomised controlled trial

Home and Online Management and Evaluation of Blood Pressure (HOME BP) using a digital intervention in poorly controlled hypertension: randomised controlled trial
Home and Online Management and Evaluation of Blood Pressure (HOME BP) using a digital intervention in poorly controlled hypertension: randomised controlled trial

Objective The HOME BP (Home and Online Management and Evaluation of Blood Pressure) trial aimed to test a digital intervention for hypertension management in primary care by combining self-monitoring of blood pressure with guided self-management. Design Unmasked randomised controlled trial with automated ascertainment of primary endpoint. Setting 76 general practices in the United Kingdom. Participants 622 people with treated but poorly controlled hypertension (>140/90 mm Hg) and access to the internet. Interventions Participants were randomised by using a minimisation algorithm to self-monitoring of blood pressure with a digital intervention (305 participants) or usual care (routine hypertension care, with appointments and drug changes made at the discretion of the general practitioner; 317 participants). The digital intervention provided feedback of blood pressure results to patients and professionals with optional lifestyle advice and motivational support. Target blood pressure for hypertension, diabetes, and people aged 80 or older followed UK national guidelines. Main outcome measures The primary outcome was the difference in systolic blood pressure (mean of second and third readings) after one year, adjusted for baseline blood pressure, blood pressure target, age, and practice, with multiple imputation for missing values. Results After one year, data were available from 552 participants (88.6%) with imputation for the remaining 70 participants (11.4%). Mean blood pressure dropped from 151.7/86.4 to 138.4/80.2 mm Hg in the intervention group and from 151.6/85.3 to 141.8/79.8 mm Hg in the usual care group, giving a mean difference in systolic blood pressure of -3.4 mm Hg (95% confidence interval -6.1 to -0.8 mm Hg) and a mean difference in diastolic blood pressure of -0.5 mm Hg (-1.9 to 0.9 mm Hg). Results were comparable in the complete case analysis and adverse effects were similar between groups. Within trial costs showed an incremental cost effectiveness ratio of £11 ($15, €12; 95% confidence interval £6 to £29) per mm Hg reduction. Conclusions The HOME BP digital intervention for the management of hypertension by using self-monitored blood pressure led to better control of systolic blood pressure after one year than usual care, with low incremental costs. Implementation in primary care will require integration into clinical workflows and consideration of people who are digitally excluded. Trial registration ISRCTN13790648.

0959-8146
McManus, Richard
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Little, Paul
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Stuart, Beth
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Morton, Katherine Sarah
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Raftery, James
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Kelly, Joanne Marie
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Bradbury, Katherine
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Zhang, Jin
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Zhu, Shihua
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Murray, Elizabeth
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May, Carl R.
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Mair, Frances
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Michie, Susan
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Smith, Peter W.F.
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Band, Rebecca
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Ogburn, Emma
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Allen, Julie
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Rice, Cathy
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Nuttall, Jacqui
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Williams, Bryan
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Yardley, Lucy
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McManus, Richard
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Little, Paul
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Stuart, Beth
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Morton, Katherine Sarah
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Raftery, James
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Kelly, Joanne Marie
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Bradbury, Katherine
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Zhang, Jin
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Zhu, Shihua
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Murray, Elizabeth
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May, Carl R.
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Mair, Frances
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Michie, Susan
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Smith, Peter W.F.
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Band, Rebecca
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Ogburn, Emma
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Allen, Julie
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Rice, Cathy
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Nuttall, Jacqui
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Williams, Bryan
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Yardley, Lucy
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McManus, Richard, Little, Paul, Stuart, Beth, Morton, Katherine Sarah, Raftery, James, Kelly, Joanne Marie, Bradbury, Katherine, Zhang, Jin, Zhu, Shihua, Murray, Elizabeth, May, Carl R., Mair, Frances, Michie, Susan, Smith, Peter W.F., Band, Rebecca, Ogburn, Emma, Allen, Julie, Rice, Cathy, Nuttall, Jacqui, Williams, Bryan and Yardley, Lucy (2021) Home and Online Management and Evaluation of Blood Pressure (HOME BP) using a digital intervention in poorly controlled hypertension: randomised controlled trial. British Medical Journal, 372, [m4858]. (doi:10.1136/bmj.m4858).

Record type: Article

Abstract

Objective The HOME BP (Home and Online Management and Evaluation of Blood Pressure) trial aimed to test a digital intervention for hypertension management in primary care by combining self-monitoring of blood pressure with guided self-management. Design Unmasked randomised controlled trial with automated ascertainment of primary endpoint. Setting 76 general practices in the United Kingdom. Participants 622 people with treated but poorly controlled hypertension (>140/90 mm Hg) and access to the internet. Interventions Participants were randomised by using a minimisation algorithm to self-monitoring of blood pressure with a digital intervention (305 participants) or usual care (routine hypertension care, with appointments and drug changes made at the discretion of the general practitioner; 317 participants). The digital intervention provided feedback of blood pressure results to patients and professionals with optional lifestyle advice and motivational support. Target blood pressure for hypertension, diabetes, and people aged 80 or older followed UK national guidelines. Main outcome measures The primary outcome was the difference in systolic blood pressure (mean of second and third readings) after one year, adjusted for baseline blood pressure, blood pressure target, age, and practice, with multiple imputation for missing values. Results After one year, data were available from 552 participants (88.6%) with imputation for the remaining 70 participants (11.4%). Mean blood pressure dropped from 151.7/86.4 to 138.4/80.2 mm Hg in the intervention group and from 151.6/85.3 to 141.8/79.8 mm Hg in the usual care group, giving a mean difference in systolic blood pressure of -3.4 mm Hg (95% confidence interval -6.1 to -0.8 mm Hg) and a mean difference in diastolic blood pressure of -0.5 mm Hg (-1.9 to 0.9 mm Hg). Results were comparable in the complete case analysis and adverse effects were similar between groups. Within trial costs showed an incremental cost effectiveness ratio of £11 ($15, €12; 95% confidence interval £6 to £29) per mm Hg reduction. Conclusions The HOME BP digital intervention for the management of hypertension by using self-monitored blood pressure led to better control of systolic blood pressure after one year than usual care, with low incremental costs. Implementation in primary care will require integration into clinical workflows and consideration of people who are digitally excluded. Trial registration ISRCTN13790648.

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HOME BP main trial manuscript no figures to submit 20200518 Revised clean final register and BMJ checks done 16102020 clean - Accepted Manuscript
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HOME BP appendix to main trial paper V0.6 20200511 Revised clean edited for style 16102020
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HOME BP Figure 1
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More information

Accepted/In Press date: 21 October 2020
e-pub ahead of print date: 20 January 2021
Published date: 20 January 2021
Additional Information: Publisher Copyright: © 2021 BMJ Publishing Group. All rights reserved. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.

Identifiers

Local EPrints ID: 445998
URI: http://eprints.soton.ac.uk/id/eprint/445998
ISSN: 0959-8146
PURE UUID: 96ea82b8-7676-4a56-be01-f30958837908
ORCID for Beth Stuart: ORCID iD orcid.org/0000-0001-5432-7437
ORCID for Katherine Bradbury: ORCID iD orcid.org/0000-0001-5513-7571
ORCID for Jin Zhang: ORCID iD orcid.org/0000-0001-9583-6000
ORCID for Peter W.F. Smith: ORCID iD orcid.org/0000-0003-4423-5410
ORCID for Rebecca Band: ORCID iD orcid.org/0000-0001-5403-1708
ORCID for Lucy Yardley: ORCID iD orcid.org/0000-0002-3853-883X

Catalogue record

Date deposited: 18 Jan 2021 17:33
Last modified: 10 Jan 2022 03:02

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Contributors

Author: Richard McManus
Author: Paul Little
Author: Beth Stuart ORCID iD
Author: Katherine Sarah Morton
Author: James Raftery
Author: Jin Zhang ORCID iD
Author: Shihua Zhu
Author: Elizabeth Murray
Author: Carl R. May
Author: Frances Mair
Author: Susan Michie
Author: Rebecca Band ORCID iD
Author: Emma Ogburn
Author: Julie Allen
Author: Cathy Rice
Author: Jacqui Nuttall
Author: Bryan Williams
Author: Lucy Yardley ORCID iD

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