A randomized controlled trial on the application of a chronic disease management platform based on digital health technology combined with an innovative model of intelligent management for hypertension in patients with hypertension

ImportanceDigital health technology (DHT)-based chronic disease management platforms combined with smart hypertension models may improve patient self-management.ObjectiveTo compare the effect of Nantong University Affiliated Hospital’s DHT platform combined with an intelligent hypertension management model (providing education, follow-up, evaluation) vs. traditional offline management on patients’ systolic blood pressure (SBP).Design, setting, and participantsThis was a two-arm, parallel-group randomized controlled trial conducted from July 2023 to March 2025. Participants were adults (≥18 years) with hypertension and uncontrolled blood pressure.InterventionsParticipants were randomly assigned using computer-generated sequences to an integrated digital health platform with intelligent hypertension management (intervention, n = 285) or to traditional offline management (control, n = 285).Main outcomesPrimary outcome: SBP at 12 months. Secondary outcomes: Diastolic blood pressure (DBP), BMI, biochemical/metabolic parameters (e.g., cholesterol, glucose, creatinine), and healthcare costs.Results547 participants completed the study (Intervention: n = 273; Control: n = 274). The intervention group achieved a greater reduction in SBP at 12 months (adjusted between-group difference: −3.14 mmHg, 95% CI: −5.24 to −1.03, P = 0.004). Subgroup analysis revealed significant heterogeneity by baseline SBP (interaction P < 0.001). For participants with baseline SBP below the median (<146 mmHg), the intervention group achieved a significantly larger SBP reduction (between-group difference: −6.79 mmHg, 95% CI: −9.62 to −3.96). It is expected that a decrease of 5 mmHg can reduce the risk of cardiovascular events by about 10%.