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

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 .

Implementing a digital intervention for managing uncontrolled hypertension in Primary Care: a mixed methods process evaluation

“…In this trial, practitioners initiated medication escalation in response to 53% of recommendations, which is comparable to a previous hypertension tele-monitoring trial in which medication escalations were patient-initiated (55%) [12], and exceeds a US telemonitoring trial in which physicians initiated 41% of recommended changes [31]. However, despite only moderate adherence to medication escalations, the RCT found that HOME BP did significantly reduce blood pressure in the intervention group [12]. Therefore, is moderate adherence to medication escalation sufficient, or even optimal, and could cases of non-adherence be described as innovation rather than subversion?…”

“…A challenge for process evaluations is distinguishing between innovative adaptations to account for contextual variation and subversion or infidelity to intervention procedures [14]. In this trial, practitioners initiated medication escalation in response to 53% of recommendations, which is comparable to a previous hypertension tele-monitoring trial in which medication escalations were patient-initiated (55%) [12], and exceeds a US telemonitoring trial in which physicians initiated 41% of recommended changes [31]. However, despite only moderate adherence to medication escalations, the RCT found that HOME BP did significantly reduce blood pressure in the intervention group [12].…”

“…This ensured both practitioners and patients remained in close contact and if either had any concerns about the medication escalation, the recommendation could be overridden. HOME BP was found to successfully increase antihypertensive medication escalations in Primary Care, and led to significant reductions in systolic blood pressure [12]. A qualitative process evaluation of patients' experiences of using HOME BP showed that perceived benefits included reassurance that uncontrolled hypertension was being addressed, whilst worry about health and fitting self-monitoring into the day could be burdens for patients [13].…”

Helping Patients Manage Their Own Blood Pressures: A Strategy to Address Hypertension Control in the United States

“… 5 More recently, parts of this process were leveraged in a related trial utilizing a digital intervention. 8 …”

A Count-Based Binary Decision Method For Target Blood Pressure Achievement in Home Blood Pressure Monitoring Data Interpretation For Clinical Practices

“…HBPM is known to be effective in improving patient adherence, allowing patients to engage in self-management or self-monitoring of BP 12 . Because differences in perceiving BP levels between patients and physicians are evident, HBPM may play an important role in achieving a common understanding of the diagnosis and treatment of hypertension between patients and physicians 13 .…”