Daily self-reported behavioural efficacy records on hypertension digital therapeutics as digital metrics associated with the reduction in morning home blood pressure: post-hoc analysis of HERB-DH1 trial.

Digital therapeutics for hypertension, proven effective in the HERB-DH1 trial, enable patients to record and track their daily actions and achievements to improve their lifestyles using an app. However, the association between recording daily behaviours and blood pressure (BP) reduction has not yet been investigated. We conducted a post-hoc analysis to investigate the relationship between them in the HERB-DH1 trial. We defined the counts of daily records of antihypertensive behaviour taken by the patient into the app as daily self-reported behavioural efficacy records (SER). SER was categorised into quartiles, and the trend of changes from baseline to week 12 in morning home systolic blood pressure (SBP), salt intake checklist score, and body weight was assessed. A total of 156 patients with hypertension were included in the analysis. A higher total count of SER was associated with greater SBP reduction (P for trend: 0.049). Patients with a higher SER for salt intake and weight reduction showed reductions in SBP (P for trend: 0.034 and 0.027, respectively). Furthermore, patients with higher salt intake SER exhibited a decrease in the salt intake checklist scores, and patients with greater weight reduction SER experienced a reduction in body weight (P for trend: 0.001 and 0.007, respectively). SER during digital therapeutics is associated with a reduction in morning home SBP in patients with hypertension. Enhancing patients' intrinsic motivation and self-efficacy, as evaluated by the SER, can play an important role in reducing BP by promoting lifestyle improvement. Daily self-reported behavioural efficacy records (SER) defined as the number of patient's app inputs of recall of day-by-day activity of behaviours at the end of the day, is partially affected by self-efficacy and affinity of app, resulting in the effectiveness of digital therapeutics.

Home blood pressure-lowering effect of digital therapeutics in hypertension: impact of body weight and salt intake.

Lifestyle modifications, including body weight reduction and salt restriction, help reduce blood pressure (BP). This study investigated the effects of body mass index (BMI) and salt intake on home BP reductions in unmedicated patients with hypertension receiving guideline-based lifestyle modification from doctors (control group) or with the addition of a digital therapeutics intervention. Data from the HERB Digital Hypertension 1 (HERB-DH1) pivotal trial were analyzed. Home BP was measured for 7 days before each study visit (baseline, and 4/8/12 weeks). Body weight was measured at each visit and salt intake questionnaire was answered at baseline and 12 weeks. This analysis included 302 patients with sufficient home BP monitoring data (digital therapeutics: 156; control group: 146). The reduction in morning home SBP from baseline to 12 weeks was significantly greater in the digital therapeutics vs. control group for patients with baseline BMI ≥ 25 kg/m2 and higher salt intake group (self-reported salt intake score ≥ 14) (-5.1 mmHg, p < 0.01). Patients in the digital therapeutics group who experienced a reduction in BMI and an improvement in salt intake score during the 12-week study also had a significantly greater reduction in morning home SBP compared with patients in the control group (-7.2 mmHg, p < 0.01). The digital therapeutic intervention reduced home BP the most in unmedicated patients with hypertension with high baseline BMI and salt intake score. Those with improvements in both BMI and salt intake during the digital therapeutics intervention achieved the greatest reduction in home BP vs. control.Clinical trial registration: Japan Registry of Clinical Trials (jRCT2032190148).