JMIR Publications

ABSTRACT

Background:

Digital therapeutics represents a promising approach to support the management of hypertension. Rural regions in China face significant challenges in hypertension prevention and management. Given the rapid growth in the use of internet and mobile technologies, particularly smartphones, we have developed a user-friendly WeChat mini-program “E-controlled pressure (eKongya)” to assist village doctors in managing patients with hypertension.

Objective:

This trial aimed to investigate the efficacy of digital interventions for blood pressure (BP) control in patients with hypertension.

Methods:

This open-label, cluster-randomized, controlled study was conducted at 8 villages in China. Individuals with systolic blood pressure (SBP) ≥140 mm Hg and/or a diastolic blood pressure (DBP) ≥90 mm Hg were recruited. 8 villages were randomly assigned in a 1:1 ratio to the digital intervention group or control group. The primary endpoint was the hypertension control rate at 24 weeks in the study participants. The secondary endpoint was the change in mean SBP and DBP from baseline to 24 weeks. All analyses were performed using the full analysis set population.

Results:

Between June and July, 2024, a total of 95 participants were enrolled and allocated to the digital intervention group (n=48) or the control group (n=47). After 24 weeks, data were available from 87 participants (92%), the mean age was 63.8±9.7 years, with 48% (n=42) being female. The digital intervention group (n=44) had a higher percentage of participants with controlled BP compared to the control group (n=43), though this difference was not statistically significant (57% vs. 49%, P=.60). Logistic regression analysis showed that the digital interventions did not significantly increase the hypertension control rate [odds ratio (OR): 0.73, 95% confidence interval (CI): 0.31-1.69, P=.46]. In the intervention group, SBP decreased from 158.0 mm Hg [standard deviation (SD) 18.4] at baseline to 137.5 mm Hg (13.0) at 24 weeks and DBP decreased from 93.8 mm Hg (10.3) to 85.3 mm Hg (11.6). In the control group during that same period, SBP decreased from 161.1 mm Hg (18.2) to 139.6 mm Hg (13.2) and DBP decreased from 99.2 mm Hg (9.2) to 83.4 mm Hg (12.1). After adjusting for baseline SBP or DBP, the mean change from baseline to 24 weeks was comparable between the digital intervention and control groups for both SBP [between-group difference -1.6, 95% confidence interval (CI) -7.2 to 3.9, P=.56] and DBP (between-group difference 3.3, 95% CI -1.8 to 8.5, P=.21). No major programme-related safety events occurred up to 24 weeks.

Conclusions:

Our study demonstrated that the digital interventions increased hypertension control rate in rural areas, although this improvement was not statistically significant. Nevertheless, providing convenient BP measurements and health education to these patients notably enhanced hypertension control rates. Clinical Trial: Chinese Clinical Trial Registry ChiCTR2500096583; http://www.chictr.org.cn/bin/project/edit?pid=255627.