A randomised controlled trial of a digital intervention for poorly controlled hypertension: Home and Online Management and Evaluation of Blood Pressure (HOME BP)
McManus R., Little P., Stuart B., Ogburn E., Allen J.
<p><strong>Objective:</strong> The HOME BP trial aimed to test a digital intervention for management of hypertension in primary care combining self-monitoring of blood pressure with guided self-management.</p> <p><strong>Design:</strong> Unmasked randomised controlled trial with automated ascertainment of primary end point.</p> <p><strong>Setting:</strong> 79 UK General Practices.</p> <p><strong>Participants:</strong> 622 people with treated but poorly controlled hypertension (>140/90mmHg) and access to the internet.</p> <p><strong>Interventions:</strong> Participants were randomised using a minimisation algorithm to either self-monitoring of blood pressure (BP) with a digital intervention (305 participants) or usual care using clinic BP (317 participants). The digital intervention provided feedback of BP results to patients and professionals with optional lifestyle advice and motivational support. Target BP for hypertension, diabetes and over 80’s followed UK national guidelines.</p> <p><strong>Main Outcome Measures:</strong> The primary outcome was difference in systolic BP after one year, adjusted for baseline BP, BP target, age and practice, with multiple imputation for missing values.</p> <p><strong>Results:</strong> After one year, data were available from 552 participants (88.6%) with imputation for the remaining 70 (11.4%). BP dropped from 151.7/86.4mmHg to 138.4/80.2mmHg in the intervention group and 51.7/85.3mmHg to 141.8/79.8mmHg in the usual care group giving a mean difference in BP of -3.5 (95% confidence interval -6.2, -0.9) / -0.6 (-1.9, 0.8) mmHg. Results were comparable in the complete case analysis and adverse effects were similar between groups. Considering within trial costs, these showed an incremental cost effectiveness ratio of £11 (6, 29) per mmHg reduction.</p> <p><strong>Conclusions:</strong> The HOME BP digital intervention for the management of hypertension, utilising selfmonitored BP, led to significantly lower BP than usual care using clinic BP at low incremental cost. Implementation in primary care will require integration into clinical workflows and consideration of those currently digitally disenfranchised.</p>