Background: Behavioural counselling via internet- or mobile-based digital platforms is recommended for hypertension; however, outcome heterogeneity is problematic in trials of this digital intervention. Our objective was to assess how therapeutic outcome was optimized in digital trials for hypertension, according to key features of the intervention design and protocol.
Methods: We identified randomized controlled digital trials for systolic blood pressure (SBP) reduction in taskforce guideline and policy statements, systematic reviews, and meta-analyses published since 2010, by searching the EMBASE, Cochrane Library, psycINFO, and PubMed databases. This search was updated to January 2019. Trials included patients with elevated cardiovascular risk or cardiovascular disease. We classified digital trials by the number of components of the intervention, and whether the protocol was organized by an explicit model of behavioural change or counselling. The influence of these features was evaluated for treatment efficacy and heterogeneity of SBP outcomes.
Results: Seventeen trials met inclusion criteria: pooled n = 5780, 33% female, 93% taking antihypertensive medications. SBP reduction was -7.3 mm Hg for digital counselling (95% confidence interval: -7.0 to -7.5) vs -3.6 mm Hg for control (95% confidence interval: -3.4 to -3.9), P < 0.0001, with high-moderate heterogeneity (I2 = 67%). Trials with multiple behavioural intervention components and an organized theoretical framework of behaviour change or counselling demonstrated optimal SBP reduction with low-moderate heterogeneity (I2 = 49%).
Conclusions: Digital health interventions optimize the efficacy of medical therapy for SBP reduction. There is opportunity to promote a disruptive change in clinical science that accompanies technological developments in digital health promotion.
Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.