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

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Dwelling and Online Management and Evaluation of Claret Force per unit area (HOME BP) using a digital intervention in poorly controlled hypertension: randomised controlled trial

BMJ 2021; 372 doi: https://doi.org/10.1136/bmj.m4858 (Published twenty Jan 2021) Cite this equally: BMJ 2021;372:m4858

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  1. Richard J McManus , professor1,
  2. Paul Lilliputian , professortwo,
  3. Beth Stuart , statisticiantwo,
  4. Katherine Morton , research acquaintance3,
  5. James Raftery , professor2,
  6. Jo Kelly , trial manager2,
  7. Katherine Bradbury , senior research fellow3,
  8. Jin Zhang , enquiry associate3,
  9. Shihua Zhu , health economist2,
  10. Elizabeth Murray , professor4,
  11. Carl R May , professorv,
  12. Frances S Mair , professor6,
  13. Susan Michie , professor7,
  14. Peter Smith , professortwo,
  15. Rebecca Band , senior enquiry swain3,
  16. Emma Ogburn , senior trial managing directori,
  17. Julie Allen , senior trial managing director1,
  18. Cathy Rice , public correspondent8,
  19. Jacqui Nuttall , senior trial managerix,
  20. Bryan Williams , professorx,
  21. Lucy Yardley , professor311
  22. on behalf of the HOME BP investigators
    1. 1Nuffield Department of Primary Intendance Wellness Sciences, Academy of Oxford, Oxford OX2 6GG, UK
    2. twoPrimary Intendance and Population Sciences Unit, University of Southampton, Southampton, Uk
    3. 3School of Psychology, University of Southampton, Southampton, UK
    4. iveHealth Unit of measurement, Research Department of Chief Care and Population Health Sciences, University College London, London, United kingdom
    5. 5Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, Uk
    6. 6General Practice and Main Care, Establish of Health and Wellbeing, University of Glasgow, Glasgow, UK
    7. viiUCL Heart for Behaviour Change, University College London, London, Great britain
    8. viiiPatient and Public Contributor, Bristol, Great britain
    9. nineSouthampton Clinical Trials Unit of measurement, University of Southampton, Southampton, UK
    10. 10Found of Cardiovascular Sciences, NIHR UCL Hospitals Biomedical Research Eye, Academy College London, London, UK
    11. 11School of Psychological Science, University of Bristol, UK
    1. Correspondence to: R J McManus richard.mcmanus{at}phc.ox.air-conditioning.uk (or @RichardJMcManus on Twitter)
    • Accepted 21 October 2020

    Abstract

    Objective The Dwelling house BP (Home and Online Management and Evaluation of Claret Pressure) trial aimed to test a digital intervention for hypertension direction in chief care by combining self-monitoring of blood force per unit area with guided cocky-management.

    Design Unmasked randomised controlled trial with automated ascertainment of primary endpoint.

    Setting 76 full general practices in the Great britain.

    Participants 622 people with treated but poorly controlled hypertension (>140/xc mm Hg) and access to the cyberspace.

    Interventions Participants were randomised past using a minimisation algorithm to self-monitoring of claret force per unit area with a digital intervention (305 participants) or usual care (routine hypertension care, with appointments and drug changes fabricated 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 anile 80 or older followed UK national guidelines.

    Primary upshot measures The master result was the difference in systolic blood pressure (hateful of 2nd and tertiary readings) later one year, adjusted for baseline blood pressure, claret pressure target, age, and practice, with multiple imputation for missing values.

    Results After one year, data were available from 552 participants (88.vi%) with imputation for the remaining 70 participants (xi.4%). Mean blood pressure dropped from 151.seven/86.4 to 138.4/80.two mm Hg in the intervention group and from 151.vi/85.3 to 141.eight/79.8 mm Hg in the usual intendance group, giving a mean divergence in systolic blood pressure of −three.iv mm Hg (95% confidence interval −six.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 instance analysis and agin effects were similar between groups. Within trial costs showed an incremental cost effectiveness ratio of £11 ($15, €12; 95% conviction interval £six to £29) per mm Hg reduction.

    Conclusions The Dwelling house BP digital intervention for the direction of hypertension by using cocky-monitored blood pressure led to better control of systolic claret pressure later on one year than usual care, with low incremental costs. Implementation in master intendance will require integration into clinical workflows and consideration of people who are digitally excluded.

    Introduction

    Hypertension is the major take a chance factor for cardiovascular disease internationally and evidence from several randomised controlled trials shows that this adventure tin be reduced by lowering claret pressure level.12 In the Uk, well-nigh thirty% of adults have raised claret pressure (≥140/90 mm Hg), with the proportion increasing to more than 50% in people aged 65 and older.3 Target blood pressure levels are reached for less than half of adults, and with an ageing population, novel interventions are required to better claret pressure control.34

    Digital interventions (apps, programmes, or software used in a wellness context) have the potential to support people in self-management.45 A digital intervention adult by our group that facilitates lifestyle change in primary care patients with obesity resulted in cost constructive weight loss.half dozen Still, for patients with hypertension, evidence for digital interventions has been from small trials with relatively short follow-upwardly and substantial heterogeneity of results.7 One trial that lasted longer than 10 months reported that patients' blood pressure was non reduced.8 We have previously shown that self-monitoring combined with cocky-titration of antihypertensive drugs is toll constructive and leads to considerably lower blood pressure level in people with essential hypertension and those at higher risk. However, this approach requires extensive transmission record keeping, which makes implementation difficult.9101112 Therefore, a digital intervention that combines our previous knowledge of cocky-management of hypertension with digital support and lifestyle changes might outcome in lower claret pressure with associated lifestyle changes, including weight management. This intervention could be more easily integrated into clinical intendance by patients and healthcare professionals, and would allow remote monitoring, an important consideration when people are restricted to staying home because of disability or to avert exposure to infection. Clinical monitoring of these patients would exist hard or impossible.13

    The HOME BP trial aimed to evaluate whether a digital intervention comprising self-monitoring of blood pressure with reminders and predetermined drug changes combined with lifestyle change support resulted in lower systolic blood pressure in people receiving handling for hypertension that was poorly controlled, and whether this approach was price effective.

    Methods

    The methods of the Domicile BP trial accept already been described in detail.14 Briefly, it was an unmasked randomised controlled trial with automated ascertainment of outcome. The written report compared a digital intervention for hypertension management and self-monitoring of blood force per unit area with usual care (routine hypertension care, with appointments and drug changes made at the discretion of the general practitioner).

    Population

    Eligible participants were aged 18 or older with treated hypertension, a mean baseline claret pressure level reading (calculated from the second and third blood pressure readings) of more than 140/xc mm Hg, and were taking no more three antihypertensive drugs. For the digital intervention, participants needed to be willing to self-monitor and have access to the cyberspace (with back up from a family unit member if needed).

    Exclusions included blood pressure greater than 180/110 mm Hg, atrial fibrillation, hypertension not managed by their general practitioner, chronic kidney disease stage iv-5, postural hypotension (>twenty mm Hg systolic drop), an astute cardiovascular issue in the previous iii months, terminal illness, or another condition which in the stance of their general practitioner made participation inappropriate.

    Procedure

    We used practices from the National Establish for Health Research Clinical Inquiry Network (https://www.nihr.air conditioning.united kingdom/explore-nihr/support/clinical-research-network.htm). Eligible people were identified from clinical codes recorded in the electronic wellness records of collaborating general practices; these people were invited to attend a baseline clinic to learn virtually the study. At the dispensary, eligibility was established, informed consent was obtained from people who wished to participate, and their baseline clinical information were nerveless. People who did not want to take part in the trial were given the option to complete a grade giving their reasons. Written report nurses measured participants' blood pressure level after 5 minutes' rest using a standardised technique with a validated electronic automated sphygmomanometer (BP TRU BPM 200).15 6 claret pressure readings were taken at intervals of one minute. All participants completed online questionnaires.

    Eligible participants were randomised using an online system (https://www.lifeguideonline.org) in a 1:one ratio to receive usual care or the Home BP intervention with optional nurse support. Minimisation factors were participants' baseline systolic blood pressure level, age, diabetes status, and practice. Practice staff were notified of patient grouping allocation by email.

    After randomisation, all patients received a blood pressure drug review from a general practitioner or nurse prescriber (prescribers). For patients allocated to the intervention group, prescribers were asked to select and agree an individualised drug titration plan (including three potential drug changes if blood pressure remained in a higher place target).ten Participating clinicians were given information about the National Establish for Wellness and Care Excellence (NICE) guidance within the Domicile BP intervention but were non asked to follow set algorithms for drugs.

    Six and 12 months after randomisation, participants attended follow-up appointments with an independent inquiry nurse where blood force per unit area and weight were recorded (weight was recorded at 12 months only). Participants and so completed follow-up questionnaires online.

    Intervention

    The HOME BP intervention for the self-management of high blood pressure consisted of an integrated patient and healthcare practitioner online digital intervention, blood pressure level self-monitoring, healthcare practitioner directed and supervised titration of antihypertensive drugs, and user selected lifestyle modifications. The intervention was developed using a theory, evidence, and person based approach16 that was designed to influence the behaviour of participants and healthcare professionals. The development process has been fully described elsewhere; briefly, it comprised an iterative process including think aloud interviews to provide detailed feedback on the Habitation BP prototype.171819

    Participants were given online instructions on how to correctly undertake cocky-monitoring (using an Omron M3 monitor), with a demonstration video.twenty Participants were then asked to rehearse self-monitoring for a minimum of seven days and enter these initial readings into HOME BP online earlier undertaking study procedures.

    Participants were brash, with automatic email reminders, to take two forenoon blood pressure readings for seven days each month and to enter online each 2nd reading (following methods used in the TASMINH2 and TASMIN-SR studies).2122 Mean abode blood force per unit area was then calculated and feedback provided to the participants and the healthcare practitioners by using a traffic light system (developed from the organisation used in previous drug titration procedures).2122 When mean home blood pressure was higher up target for two sequent months, the prescriber was asked by email to implement the preplanned drug change.

    The following habitation blood pressure targets were set in line with upward-to-date Dainty hypertension guidelines23; an adjustment of 5/5 mm Hg was made for home readings24:

    • People younger than 80 without diabetes: less than 135/85 mm Hg

    • People anile eighty and over without diabetes: less than 145/85 mm Hg

    • People with diabetes: less than 135/75 mm Hg.

    When dwelling house blood pressure readings were very high (>180/110 mm Hg) or very low (systolic claret pressure <100 mm Hg), patients were advised to call their general practitioner within iii days and HOME BP healthcare practitioners were alerted by email. If mean home blood pressure was controlled for three sequent months (defined as 100-134/≤84 mm Hg), patients were brash to reduce blood pressure monitoring to once every eight weeks; monitoring reverted back to every month if hateful blood pressure subsequently increased above 135/85 mm Hg.

    The HOME BP intervention included elements designed to motivate and support healthy behaviours. Information was presented well-nigh the health related benefits of self-monitoring, most reducing blood force per unit area through drugs, and addressing common patient concerns about the side furnishings of drugs. Ix weeks after participants were allocated to the intervention (judged to be sufficient fourth dimension for self-monitoring habits to have been implemented), an optional tool became available outlining user selected prove based lifestyle modifications that target healthy eating, concrete activity, losing weight (if appropriate), and table salt and alcohol reduction.14 The health behaviours targeted were chosen based on normalisation procedure theory and took the form of web pages and links.17

    The Abode BP intervention also aimed to build healthcare practitioner motivation, knowledge, and skills to reduce clinical inertia.17 This objective was achieved by presenting show of efficacy and addressing concerns almost patient titration acceptance, the reliability of home blood force per unit area readings, and study procedures.

    Optional additional behavioural back up for self-monitoring and lifestyle modifications was available to intervention participants through practice nurses or healthcare assistants (referred to every bit supporters) by using the Care (congratulate, ask, reassure, encourage) approach.17 This support comprised up to six cursory face-to-face, telephone, or electronic mail contacts addressing difficulties associated with self-monitoring or lifestyle change, with additional monthly electronic mail back up provided by using prewritten templates.

    Usual care

    Participants allocated to usual care were not provided with self-monitoring equipment or the Dwelling house BP intervention, but had online access to the information provided in a patient leaflet for hypertension (patient.co.uk; through the same organisation that delivered the online questionnaires). This data comprised definitions of hypertension, causes, and brief guidance on treatment, including lifestyle changes and drugs. These participants received routine hypertension intendance that typically consisted of clinic blood force per unit area monitoring to titrate drugs, with appointments and drug changes made at the discretion of the general practitioner. Participants were not prevented from cocky-monitoring; data on cocky-monitoring practices were collected at the end of the trial from patients and practitioners.

    In intervention and usual care groups, decisions about patients' drugs remained at the prescriber'due south discretion at all times.

    Outcomes

    The primary event of the trial was the divergence in clinic systolic blood pressure (hateful of second and third readings) at 12 month follow-upward between the intervention and usual intendance groups, adjusting for baseline blood force per unit area, practice, blood pressure target levels, and sex. Secondary outcomes (also adjusted for baseline and covariates if appropriate) included systolic and diastolic claret pressure at half-dozen and 12 months using second and third blood pressure level readings, and second to sixth blood pressure readings; weight; modified patient enablement instrument (patients' feelings of confidence about understanding their illness and their ability to manage, understand, and cope with their condition; and full general health problems that occurred after receiving healthcare)2526; drug adherence (Medication Adherence Rating Scale questionnaire)27; health related quality of life measured with the EuroQoL-5D-5L28; and side effects from the symptoms section of an adapted affliction perceptions questionnaire.29

    After trial registration, participants and general practitioners were asked nigh use of self-monitoring in the usual care group. At the terminate of the trial a medical tape review captured prescription of antihypertensive drugs (including any changes) and within trial principal healthcare resource use (chief care and secondary care, including outpatient and inpatient visits). Additional outcomes that will exist published elsewhere included long term economic modelling and a detailed procedure evaluation.

    Power adding and assay

    A sample size of 244 patients for each group was required to have 90% power to detect a difference in systolic claret pressure level of 5 mm Hg (standard deviation 17 mm Hg) between the intervention and usual care groups based on the findings from the TASMINH-ii study.22 Allowing for a 15% participant dropout, 287 participants were required for each group, resulting in a total sample size of 574 participants. During the trial, we decided to increase the sample size to 610 to let for a 20% dropout rate because of concerns about higher than expected initial dropout (which afterwards proved unfounded).

    The chief analysis used raw and adjusted data, and was agreed in a statistical analysis plan before final data lock (encounter appendix). The primary assay used general linear modelling to compare systolic blood force per unit area in the intervention and usual care groups at follow-up, adjusting for baseline blood pressure, practise (as a random result to take into business relationship clustering), blood pressure target levels, and sexual practice. Analyses were on an intention-to-treat footing and used 100 multiple imputations by chained equations for missing information. The imputation model included all outcome and stratification variables. Sensitivity analyses used complete cases and also a repeated measures technique. Planned subgroup analyses included blood pressure target groups, older versus younger participants (67 as threshold), men versus women, lower index of multiple deprivation scores versus higher scores, and claret pressure better controlled at baseline versus worse controlled at baseline (above or below median systolic blood pressure). Secondary analyses used similar techniques to assess differences between groups. Postal service hoc we decided to present antihypertensive drugs as the number of dose changes and drug changes rather than as defined daily dose (which combines dose and number of drugs) to show the specific type of changes more conspicuously.

    A within trial economical assay estimated cost per unit reduction in systolic blood pressure—the primary outcome—by using similar adjustments and multiple imputation for missing values as described in the statistical analysis section. UK National Wellness Service resource utilise costs included those due to the intervention and those due to changes in drugs and apply of other relevant NHS resources. The following items were costed (farther details in appendix table A6):

    • Antihypertensive drugs (past dose and dose changes, and any new antihypertensive drugs, all by number of days used) from NHS drug tariff 201830

    • Chief intendance contact related to blood pressure (by type of staff—full general practitioner, do nurse, or healthcare assistant) and type of contact (face to face, telephone, email, or text, including clinical contacts from supporting the intervention)31

    • Inpatient access (by health resource use code), outpatient visit, or emergency section attendance related to hypertension.32

    We used repeated (1000 times) bootstrapping to estimate the probability of the intervention being cost effective at different levels of willingness to pay per unit reduction in blood pressure.

    Trial registration and approvals

    HOME BP is registered equally ISRCTN13790648 (https://doi.org/10.1186/ISRCTN13790648). The original registration was for the evolution and pilot phase, which ran into the main trial without change. Except for an increase in sample size every bit documented higher up, no other substantive changes were made to the protocol after the start of the trial. The trial registration did not specify which blood pressure measurements were to be used in the secondary outcomes, but these were clarified in the statistical analysis program before data lock as the mean of the second and third measurements, and the mean of the 2nd to sixth measurements. Post hoc analyses are stated.

    Patient and public interest

    Patient and public contributors were involved from the outline application stage (Samantha Hall and Mark Stafford-Watson). At total awarding phase these contributors were joined past Keith Manship and Shelley Mason. Cardinal aspects contributed to were the development of the intervention, commenting on trial documentation, and taking part in the steering group meetings. Cathy Rice joined equally a patient and public contributor during the trial and has remained extensively involved, including optimising many patient facing documents and intervention training content, authorship of this newspaper and assisting in broadcasting. We are immensely grateful for the input of all of our public contributors.

    Results

    Of 11 399 invitation letters sent out, 1389 (12%) potential participants from 76 general practices responded positively and were screened for eligibility. Those who declined to take office could optionally give their reasons, and responses were gained from 2426/ten 010 (24%). The mean historic period of those who gave a reason for declining was 73 years. The well-nigh normally selected responses were not having access to the internet (982, 41%), not wanting to be part of a enquiry trial (617, 25%), not wanting to participate in an internet study (543, 22%), and non wanting to change drugs (535, 22%; table A1).

    Of the 1389 screened, 734 were ineligible and so were excluded (fig i). A further 33 did non consummate baseline measures and randomisation, which left 622 people who were randomised to the Dwelling house BP intervention or usual care (305 and 317, respectively; proportions are in line with the minimisation algorithm). The main reasons for exclusion (denominator 734 in each example) were blood pressure level less than 140/xc mm Hg (652, 89%), postural hypotension (31, 4%), not taking antihypertensive drugs (eighteen, 2%), and blood pressure as well high (>180/110 mm Hg; 16, 2%). Fifteen people (2%) who did not fulfil the inclusion criteria considering their claret pressure was out of range were randomised in mistake (in 10 people claret pressure was too high; in five people blood pressure was too low). After nosotros discussed the result with the sponsor and with the relevant general practitioners, nosotros decided to keep these people in the trial unless they wished to withdraw, and they have been included in the intention-to-care for assay.

    Fig 1

    Fig one

    Flowchart of Habitation BP (Home and Online Management and Evaluation of Blood Pressure) trial. *Partial withdrawals withdrew from the intervention but consented to be followed upwardly. †Partial withdrawals in usual care consented to passive follow-upward

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    The groups were well matched, with a mean age of 66 years and hateful baseline clinical claret pressure of 151.half dozen/85.3 mm Hg and 151.7/86.4 mm Hg (usual care and intervention, respectively; table 1). Almost participants were white British (94%), just over half were men, and fourth dimension since diagnosis averaged effectually eleven years. The most deprived group accounted for 63/622 (x%), with the least deprived grouping accounting for 326/622 (52%).

    Table 1

    Baseline characteristics of usual care and intervention groups in the Domicile BP trial. Information are numbers (percentages) unless stated otherwise

    After 12 months, primary endpoint data were available from 271 (89%) participants in the intervention group and 282 (89%) in the usual care grouping (fig 1). Clinic blood pressure dropped from 151.7/86.4 to 138.4/80.2 mm Hg in the intervention group after 12 months, and from 151.half dozen/85.3 to 141.8/79.viii mm Hg in the usual care group; this gave a mean difference of −iii.iv mm Hg (95% confidence interval −6.one to −0.eight) in systolic blood pressure level and −0.5 mm Hg (−one.nine to 0.9) in diastolic blood pressure (tabular array 2). The results were like in the complete case analysis and showed a smaller but withal significant effect size when because the mean of the second to sixth blood pressure readings (table A2). Similarly, considering the main outcome data as repeated measures over the 12 months and decision-making for baseline, a significant difference remained betwixt groups in favour of the HOME BP intervention: −2.9 mm Hg (95% confidence interval −four.8 to −1.1 mm Hg) for systolic claret pressure and −0.6 mm Hg (−one.6 to 0.5 mm Hg) for diastolic blood pressure.

    Table 2

    Mean (standard deviation) claret pressure at baseline, half dozen months, and 12 months using second and third measurements, and adjusted deviation

    A postal service hoc analysis showed that claret pressure dropped past at least 5 mm Hg in 201/270 (74.iv%) of the intervention group compared with 170/282 (60.iii%) of those receiving usual care: adapted odds ratio for a 5 mm Hg drop: ane.9 (95% confidence interval one.3 to two.viii; controlling for practise level clustering and stratification factors).

    Exploratory subgroup analyses (fig two, table A3) suggested that participants aged 67 or older had a smaller effect size (−0.4 mm Hg, 95% confidence interval −three.nine to three.0 mm Hg) than those younger than 67 (−vii.seven mm Hg, −eleven.9 to −3.5 mm Hg). Similarly, while the event sizes in the standard and diabetes target groups were like (−four.0 mm Hg, −vi.nine to −1.one mm Hg; −3.8 mm Hg, −13.4 to 5.8 mm Hg, respectively), those older than fourscore years with a higher target of 145/85 mm Hg showed footling prove of benefit (1.5 mm Hg, −7.4 to 10.four mm Hg). Results for other subgroups, including sex, baseline claret pressure, deprivation, and history of self-monitoring, were similar betwixt groups; however, it is possible that those with comorbidities gained less from the intervention (systolic blood force per unit area difference, controlled for age—no comorbidity: −5.1 mm Hg, −eight.4 to −1.8 mm Hg; one comorbidity: −0.6 mm Hg, −5.viii to 4.5 mm Hg; multiple comorbidities: −2.0 mm Hg, −eleven.1 to seven.2 mm Hg).

    Data about possible adverse effects was derived from an extended version of the illness perceptions questionnaire symptoms department and showed no differences betwixt groups29 (table iii). More than participants in the intervention group reported weight loss (29/243, 11.nine% 5 57/251, 22.7%; P=0.002), just this was not borne out by the objective weight data (mean difference −0.36 kg, 95% confidence interval −i.x to 0.38 kg; tabular array A4).

    Table 3

    Participants who reported a hypertension drug specific symptom or adverse upshot at final follow-up. Data are numbers (percentages)

    Participants who used the digital intervention were more likely to take their antihypertensive drugs adjusted during the study; this included more than changes in dose (relative risk of a dose change, intervention v usual intendance: 2.0, 95% confidence interval i.5 to 2.seven) and more changes in drugs (relative risk of a drug modify, intervention v usual intendance: i.5, 1.one to 1.9; tabular array 4). Self-reported adherence in both groups was high throughout (Medication Adherence Rating Calibration questionnaire27: median baseline 24, maximum possible 25, interquartile range 23-25; at 12 months: 24, interquartile range 23-25 in the control grouping, and 24, interquartile range 24-25 in the intervention group; P=0.97 for the difference).

    Table 4

    Number of drugs and dose changes in usual care and intervention groups

    Engagement with the digital intervention was high, with 281/305 (92%) participants completing the two cadre training sessions, 268/305 (88%) completing a week of do blood pressure readings, and 243/305 (eighty%) completing at least iii weeks of blood pressure entries (table A5). Furthermore, 214/305 (lxx%) were still monitoring in the terminal three months of participation (of 12 calendar month study). Still, less than one third of participants chose to annals on i of the optional lifestyle change modules. Of the subsample of 243 participants with a body mass index greater than 25, 46 (19%) registered on the online weight loss program.

    The patient enablement score showed a reduction over time (that is, increased enablement) in the self-direction group. This reduction meant that by 12 months a significant departure was found (−0.4, 95% confidence interval −0.5 to −0.ii) betwixt the usual care and intervention groups (tabular array five).

    Table v

    Patient enablement in usual care and intervention groups

    Subsequently 12 months, a post hoc assay showed that 112/234 (47%) patients in the usual care grouping reported monitoring their own blood pressure level at home at least once per month during the trial; of these, 78 (70%) said that they took their readings to their general practitioner. Of 56/76 (74%) general practitioners who responded, 35 (63%) reported using home readings in their titration decisions for usual care.

    The within trial analysis for quality of life (EuroQoL-5D-5L) showed no significant difference between the two groups (tabular array half dozen). The difference in hateful cost per patient was £38 ($51.iii, €41.9; 95% confidence interval £27 to £47), which along with the decrease in systolic blood pressure, gave an incremental price per mm Hg blood pressure reduction of £11 (£half dozen to £29; table 7). Figure A1 shows the results of bootstrapping the incremental cost and blood pressure gains, which are summarised in the toll effectiveness acceptability curves (fig A2). These curves show the intervention had high (90%) probability of being cost effective at willingness to pay above £twenty per unit of measurement reduction. The probabilities of being cost effective for the intervention confronting usual care were 87%, 93%, and 97% at thresholds of £xx, £thirty, and £50, respectively.

    Table 6

    Quality of life measured past using EuroQoL-5D-5L in usual care and intervention groups. Data are hateful (standard deviation) unless stated otherwise

    Table 7

    Costs, systolic blood pressure reduction from baseline, and incremental cost per blood pressure reduction past using bootstrap methods based on imputed blood pressure data. Data are mean (95% conviction interval)

    Discussion

    Main findings

    A digital intervention enabling self-management of hypertension, including self-monitoring, titration based on cocky-monitored blood force per unit area, lifestyle advice, and behavioural support for patients and healthcare professionals, resulted in a worthwhile reduction of systolic blood pressure achieved at pocket-sized cost. This finding was robust in sensitivity analyses, including complete case analysis, and also when the hateful of the second to sixth blood pressure readings was used as the outcome. The reduction was achieved through increased titration of antihypertensive drugs with no increase in agin furnishings, suggesting that the Abode BP digital intervention reduces clinical inertia and leads to optimisation of treatment. The effect size observed from this intervention could exist expected to outcome in a reduction of 10-15% in patients having a stroke and a reduction of 5-10% in patients having coronary events. Given the depression marginal toll, such an event could make a major difference to the millions of people being treated for hypertension in the UK and worldwide.

    Strengths and weaknesses

    This was a large trial of a digital intervention in the field of hypertension and with follow-up for a year. Adequate ability existed to discover a departure in blood pressure, and over recruitment ensured such an effect was not missed. By recruiting from a large number of general practices, we ensured generalisability in terms of healthcare professionals. However, some bear witness was institute of preferential recruitment of those with college socioeconomic status, although we institute no show that socioeconomic condition mediated outcomes. Although white ethnicity (94%) appears over represented in comparing to the population of England and Wales every bit a whole, this reflects differences in ethnicity by age: 95% of those anile 65-69 have white ethnicity.33

    The hateful age of people declining to take part was 73, and the commonest reason cited was lack of internet access, mirroring Ofcom'south latest data showing a reduction in computer admission by socioeconomic status and age.34 While online access is increasing twelvemonth on year in all age groups and societal stratums, suggesting this barrier could exist reduced in the futurity, information technology will remain important to better understand barriers to uptake by those in more deprived areas.35 Investment in specific measures will be needed to enable the near vulnerable to appoint with digital health initiatives and mitigate the risk that digital health contributes to a widening of wellness inequality, particularly as deprivation did non change the effects of intervention.

    The study used minimisation to reduce important baseline imbalance and this has the potential to reduce the event of randomisation. However, we accept no prove that randomisation concealment was affected. Similarly imputation tin can influence results, only with high follow-upwards (89%) and equivalent complete case results this seems unlikely.

    While prescribing records suggested an increase in drug utilize, and the questionnaires suggested loftier rates of drug adherence, information were not available about filling of prescriptions or validated adherence. The best measures of drug adherence use electronic systems, which were non bachelor for this report. However, other work using such methods suggests that cocky-monitoring improves adherence.36 Taking into account all our observations, it appears likely that increased antihypertensive drug use drove lower blood force per unit area.

    The upshot size seen in this trial was slightly smaller than, only inside the confidence intervals of, our trial that assessed a similar paper based cocky-management intervention in a similar population. Additionally, the upper confidence interval crosses our prespecified clinically of import level of 5 mm Hg.ix As with our previous work, the results at 12 months showed greater divergence than at half dozen months, which suggests that the intervention might have ongoing impact. We know that just under half of patients in the control group reported self-monitoring claret pressure during the trial, and that these records were used by their general practitioners in making handling decisions; this could reduce the effect size, although cocky-monitoring outside of a more complex intervention such every bit Domicile BP has similar efficacy to usual intendance.37 Appointment with the digital intervention was high (70% were still monitoring after nine months) and equivalent to our previous piece of work, but the dwelling house monitoring target was not as low as that in TASMINH2 (systolic blood pressure 135 v 130 mm Hg) attributable to changes in national guidance, and this might accept reduced the result size.ix

    The cocky-monitoring schedule used hither was developed in our previous self-management work, but is different to that recommended in subsequent international recommendations.9103839 Yet, the requirement for 14 readings to be taken per week is in line with these recommendations, and recording the second of 2 forenoon readings each day was originally chosen to simplify self-monitoring because morning readings are better correlated with stroke adventure.40

    Subgroup assay suggested a differential effect by age, which is important given that such interventions accept been proposed as particularly relevant to the ageing population.4 Participants in the younger half of the age distribution (<67 years) accomplished twice the overall reduction in systolic claret force per unit area, and older participants (≥67 years) gained no benefit. The effect did not seem to be caused by the college target for people older than 80 years, which has not previously been observed in other trials of self-monitoring. However, also few studies of digital interventions in hypertension have been published to assess whether it is a particular consequence with the type of intervention.737 Furthermore, the ageing population besides influences ascent levels of multimorbidity, and then the suspicion that those with comorbidities gained less from the intervention as well merits further investigation.4142 Our process evaluation, which is published in item elsewhere, has not found show of access or engagement issues, or of explanatory characteristics in older people or their clinicians, but the results might have been confounded by the differential claret force per unit area target for those older than 80 years (145 mm Hg).43 Given the inclusion criteria included a systolic blood pressure level of more than 140 mm Hg, older people would non have been prompted to alter drugs until their blood pressure rose ten mm Hg higher than the younger group. Furthermore, we establish some evidence of increased uptake of concrete activity in the younger group, which might partly explicate the findings (to exist reported elsewhere).

    Relation to the literature

    Nosotros observed an increase in antihypertensive drug changes in the intervention grouping, which suggests that the Dwelling house BP intervention led to reduced clinical inertia. This miracle has been shown to result in reduced activity by clinicians in the face of bear witness, in this case of raised claret pressure level.4445 Our previous work on cocky-monitoring and direction has too resulted in increased employ of antihypertensive drugs, but the data captured hither are more detailed than has been previously possible.91046 We used a drug titration algorithm that gave clinicians the opportunity to develop individual treatment plans for their patients, which is in line with national and international guidance.3839 In tandem with reduced clinical inertia, self-direction in the context of HOME BP improved patient enablement, and this might likewise have mediated the effect. Withal, the behavioural aspects of the intervention were less successful and were only taken upwards by a small proportion of participants.

    The major advantage of a digital intervention is the ability to be deployed at a low marginal price, and the within trial cost effectiveness analysis supports this supposition. All training for the intervention was delivered online, meaning implementation tin also be price effective. This finding is reflected in the cost of £11/mm Hg reduction, which compares well with £25.66/mm Hg in the HITS trial in Scotland that used a propriety telemonitoring system.47 We would expect such a blood force per unit area reduction to lead to a longer term impact on cardiovascular events. However, to properly assess this impact on price effectiveness in the longer term, boosted modelling that takes into account these furnishings with extrapolation to a longer time horizon is needed, and nosotros are in the process of such work. Previous self-monitoring interventions have proven to be cost effective in the long term within standard parameters.1112

    Interestingly, the patient enablement musical instrument showed that patients were enabled to be more agile in controlling their hypertension. Many chose to practice this through drugs just, whereas a small number chose to include behavioural or lifestyle modifications as part of blood pressure management. The small proportions choosing behavioural support might seem counterintuitive, only equally has been pointed out before, enabled patients do not ever make the decisions that clinicians or public wellness physicians would like them to.48

    Trials of self-monitoring blood pressure announced to piece of work all-time with relatively intensive cointerventions (such equally telemonitoring, educational advice, or pharmacist input) and the electric current report fits with that literature.37 In the context of the electric current trial, we are not able to distinguish the relative importance of the different parts of the digital intervention. Relatively few studies have been performed that combine self-monitoring with a digitally delivered cointervention, and none has shown a major event in an fairly powered trial over a year.7 The HOME BP trial provides evidence that a digitally delivered intervention for hypertension can be successful over 12 months, with engagement from clinicians and patients.

    Clinical implications

    Surveys suggest that well-nigh general practitioners are drawing on self-monitoring in their hypertension direction, and that at least i third of patients with hypertension are self-monitoring.4950 Over and higher up the clinical benefit from the Home BP digital intervention, the ability to manage claret pressure remotely at scale has never been so of import as during the electric current crisis.13 Therefore, implementation of a cost effective digital intervention that leads to lower blood force per unit area would now seem to be appropriate. However, such implementation will not exist possible without some consideration of the factors that influence successful translation into daily practice.51 Some of these factors were successfully addressed in the evolution of HOME BP, which used extensive user feedback to ensure that healthcare professionals and patients had a shared, positive understanding of the aims and likely benefits of HOME BP, and perceived it every bit easy and not onerous to apply.16171819 Achieving clinician purchase-in is more likely to occur once evidence from trials such as ours is incorporated into routine clinical practice guidelines. A primal barrier to achieving such buy-in and professional usability is probably the lack of integration of the Abode BP digital intervention into electronic health records. A system to allow deployment of proven digital interventions within the United kingdom NHS and other wellness systems is now urgently needed. Examples of this are beginning to emerge; for example, general practitioners in Scotland can now get home blood pressure readings sent to their Docman electronic record organisation (PCTI Solutions, UK), although the underlying telemonitoring is SMS based and lacks much of the functionality included in the HOME BP digital intervention.52 Further work might evaluate such implementation to ensure that predicted benefits are accomplished and to permit further evolution of the intervention, particularly for older people and those from more disadvantaged backgrounds.

    Conclusions

    Overall, this digital intervention for the direction of hypertension that uses self-monitored blood pressure and behavioural techniques has led to ameliorate control of blood pressure than usual care. The HOME BP digital intervention, combined with cocky-monitoring, has the potential to provide cost effective back up for patients and professionals in lowering blood pressure. The side by side pace is an implementation strategy to realise such benefits for the whole population.

    What is already known on this topic

    • Previous trials of self-monitoring and cocky-management have shown effectiveness in reducing blood pressure level, but accept frequently relied on relatively expensive technology or time consuming training packages to realise whatever benefit

    • Short term trials of digital interventions have shown potential to improve blood pressure control, but take not provided sufficient testify for widespread implementation

    What this study adds

    • Home and Online Management and Evaluation of Blood Pressure (Dwelling house BP) is a digital intervention comprising self-monitoring of claret force per unit area with reminders and predetermined drug changes combined with lifestyle alter support for the self-management of high blood pressure

    • HOME BP resulted in better command of systolic claret pressure later on 1 yr than usual care and at low incremental cost; adverse events were similar to usual intendance

    • Digital interventions such as Abode BP have the potential to be implemented at scale in a cost effective manner

    Acknowledgments

    The authors acknowledge staff in Oxford Academy's Primary Care Clinical Trials Unit for support with the trial recruitment (listed under Habitation BP investigators) and Ali Albasri for assisting with cleaning the medical notes data; authoritative support from Victoria Hayter and Jane Somerville at Southampton University and Carla Betts at Oxford Academy; and Dr Adam Geraghty for help with the original funding application. We thank the trial steering group, including Professor Brendan Delaney (chair), Professor Hilary Pinnock, Dr Sally Kerry, and Katharine Jenner (Blood Force per unit area UK). The National Constitute for Health Enquiry clinical enquiry network facilitated practice recruitment. This enquiry would not have been possible without the support and encouragement of all patients and practise staff from the 76 participating practices.

    The Home BP investigators: Adam Jones, Ajmal Hussain, Alistair McHardy, Anna Harrison, Anna LaLonde, Asim Malik, Basilio Hernandez-Diaz, Ben Cranfield, Brian Nicholson, Carl Anandan, Catherine Neden, Cathy Bobrow, Chloe Evans, Christopher Keast, Clare Henderson, Corrine Sutherland, Craig Kyte, Dan Henderson, Debbie Noble, Ed Capo-Bianco, Edward Williams, Elizabeth Shaw, Fatima Mohri, Gaurav Asal, Greig Dougall, Hardeep Bhupal, Heidi Luckhurst, Hergeven Dosanjh, Hilary Nowell, January Brown, Jennifer Flett, Julian Barber, Heather Rutter, Julian Thompson, Kanjhana Ramanan, Karen Madronal, Karen Malone, Katie Etherington, Kenney Tsoi, Kyle Knox, Laila Amin, Lisa Hirst, Lucy Allen, Luke Skellern, Lynne Flynn and Lorne McEwan, Marker Pugsley, Marloes Frassen, Matthew Gaw, Matthew Prendergast, Matthew Wallard, Muhammad Faisal, Nick Wooding, Nienke Lees and Paul Wainman, Nithya Nanda, Patrick Moore, Paul Conley, Paul Johnson, Penny Wilson, Phillip Jacobs, Pippa Whitbred, Rebecca Zamir, Richard Reed, Richard Tribley, Richard Woof, Ruth Danson, Ruth Lawes, Sarah Gallagher, Sarah Wadsworth, Serge Macanovic, Simon Cartwright, Simon Pettitt, Simon Tucker, Stephen Doggett, Tamsin Sevenoaks, Tara Watson, Tess Talbot and Ruth Imrie, Thomas Herbert, Tony Crockett, Tony Wright, Vanshika Sharma, Vicki Telford, Zaid Almashta, Zelda Cheng, Zishan Ali, Alice Grube, Andy Claxton, Barbara Asante, Becki Weare and Eleanor McKee, Bertha Werrett, Carmel Barwell, Carole Mulvihill, Caroline Sherwood, Clare MacDonald, Dadirayi Tabor, Dawn Denning, Debbie Roberts, Diane Adshead, Gemma Clarke, Heather Huntley, Heather Pinder, Irene Qasim, Jane Merrison, Jill Male monarch, Julie Allison, Kam Johal, Karen Terry, Karine Wood, Kathryn Balmford, Katie Barnes, Katie Post, Kelly-Marie Bowden, Kirsty Edmunds, Klaire Whittle, Lara Peniket, Leann Carnegie, Linda Neale, Lisa Davey, Liz Bartlett, Louise Smith, Lucy Clack, Martina Brown, Naomi McKenna, Pam Kay, Polly Jacobs, Rebecca Cutts, Robert Pearse, Ruth Atkinson, Emerge Barter, Sally Mackie, Sam Norris, Sandra Cook, Sarah Elderfield, Sarah Nzante, Sharon Cronin, Sophie Maslen, Stephanie Marchant, Stephanie Wright, Sue Keene, Sue Smith, Suzie Cimelli, Tracy Rock, Tricia Joyce, Trudie Le Marechal, Vicky Kettle, Victoria Osborne, Wendy Cubiss, Wendy Marsden, Wioletta Kowalczyk-Williams, Zoe Bailey.

    Footnotes

    • Contributors: LY, together with PL and RJM, conceived and led the written report, providing detailed supervision of all aspects throughout. JR, EM, CRM, SM, FSM, PS, and BW provided senior expertise and leadership, contributing to designing the study, securing funding and supervising the conduct of the written report. BS carried out the statistical assay, and JR and SZ carried out the economic analysis. KM, KB, JZ, and RB adult the intervention, supported its implementation, contributed to designing the study and carried out the process evaluation. JK led trial implementation forth with EO and JA, with communication from JN, and CR was the key public contributor. All authors commented on drafts of this newspaper. RJM volition act as guarantor and affirms that the manuscript is an honest, authentic, transparent, and total business relationship of the Abode BP trial. The respective writer attests that all listed authors see authorship criteria and that no others meeting the criteria accept been omitted.

    • Funding: This paper presents independent research funded past the National Establish for Wellness Research (NIHR) under its Program Grants for Applied Enquiry (PGfAR) Plan (grant reference No RP-PG-1211-20001). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. RJM was funded by an NIHR Research Professorship 2013-eighteen (NIHR-RP-R2-12-015) and is at present an NIHR senior investigator. LY is an NIHR senior investigator and her research programme is partly supported by NIHR Practical Research Collaboration (ARC)-W, NIHR Health Protection Research Unit (HPRU) for Behavioural Scientific discipline and Evaluation, and the NIHR Southampton Biomedical Research Centre (BRC). The funders and sponsor of the study had no role in study design, data collection, information assay, data interpretation, writing of the report, or in the decision to submit for publication. The corresponding author (RJM) together with LY, BS, and JR had full access to all the data in the study. RJM had final responsibility for the conclusion to submit for publication.

    • Competing interests: All authors have completed the ICMJE compatible disclosure form at world wide web.icmje.org/coi_disclosure.pdf and declare: support from NIHR for the submitted work; Omron provided the monitors used in the HOME BP study at reduced price; RJM received BP monitors for enquiry from Omron and is collaborating with them on development of a telemonitoring system equally function of the NIHR Oxford and Thames Valley Applied Inquiry Consortium; RJM receives occasional travel and accommodation reimbursement for talks; he does not personally receive any honorariums or consultancy payments; no other relationships or activities that could appear to have influenced the submitted work.

    • Ethical approval: Ethical approval was granted from NRES Hampshire A, 19 March 2015, reference 15/SC/0082, and enquiry governance approving was gained from the relevant NHS bodies.

    • Information sharing: The HOME BP trial is a member of the BP SMART consortium of randomised controlled trials of self-monitoring in hypertension and data will be included in future meta-analyses. Anonymised trial data from HOME BP are bachelor on reasonable request from the respective writer.

    • The lead author (RJM) affirms that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study accept been omitted; and that whatever discrepancies from the report as planned (and, if relevant, registered) have been explained.

    • Dissemination to participants and related patient and public communities: A lay summary of the results of the written report will be shared with participating patients and their practices.

    • Provenance and peer review: Provenance and peer review: Not deputed; externally peer reviewed.

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    Source: https://www.bmj.com/content/372/bmj.m4858