Accepted for/Published in: JMIR mHealth and uHealth
Date Submitted: Feb 10, 2025
Date Accepted: Nov 20, 2025
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Effect of a mobile health intervention in the management of hypertension：Preliminary findings of an open-label, cluster-randomized trial
ABSTRACT
Background:
Digital therapeutics represents a promising approach to support the management of hypertension. Rural regions face significant challenges in hypertension prevention and management in China. 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 hypertension patients.
Objective:
This trial aimed to investigate the efficacy of digital intervention for the 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:
After 24 weeks, data were available from 87 participants (91.6%), the mean age was 63.8±9.7 years, with 48.3% (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 (56.8% vs. 48.8%, p=0.596). In the intervention group, SBP decreased from 158.0 mm Hg (SD 18.4) at baseline to 137.5 mm Hg (13.0) at 24 weeks and DBP decreased from 93.8mm 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 99.2mm Hg (9.2) to 83.4mm 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 = 0.562] and DBP (between-group difference 3.3, 95% CI -1.8 to 8.5, P = 0.205). No major programme-related safety events occurred up to 24 weeks.
Conclusions:
Our study demonstrated that providing convenient BP measurements and health education to patients in rural areas significantly improved hypertension control rates, although the efficacy of digital interventions was not found to be significant. Clinical Trial: This study was registered in the Chinese Clinical Trial Registry under the registration number: ChiCTR2500096583.
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