A simplified management model combining telemedicine, home BP monitoring, and single-pill combination therapy significantly reduced systolic BP compared to usual care (-9.7 vs -5.8 mmHg; p=0.033).
RCT (n=364)
Open-label
1:1
Yes
Does a simplified management model combining telemedicine, home BP monitoring, and single-pill combination therapy improve blood pressure control in adults with uncontrolled hypertension?
Integrating single-pill combination therapy with telemedicine and home BP monitoring significantly improves blood pressure control, medication adherence, and quality of life compared to usual care.
Absolute Event Rate: -9.7% vs -5.8%
p-value: p=0.033
Abstract Background Effective blood pressure (BP) control is critical for preventing cardiovascular diseases, yet consistent management remains challenging. This study aimed to evaluate whether a simplified management model combining telemedicine, home BP monitoring, and single-pill combination therapy (SPC) improves BP control compared with usual care involving conventional BP self-monitoring. Methods This open-label, multicenter randomized controlled trial was conducted across four medical centers in our city, China. Participants aged 18–75 years with uncontrolled hypertension (office BP =140/90 mmHg) were randomized (1:1) into a telemedicine group or a usual care group. The telemedicine group received SPC therapy guided by telemedicine consultations, with medications delivered directly to participants' homes, combined with encouraged home BP self-monitoring. The usual care group performed BP self-monitoring without therapy adjustments. A mobile phone-based system was used to remind participants in both groups to take regular home BP measurements. Randomization was stratified by site and implemented using a centralized system. The primary endpoint was the change in mean systolic BP (SBP) from baseline to 6 months. Secondary endpoints included diastolic BP (DBP) changes, BP control rates, and medication adherence. Exploratory outcomes assessed quality of life, disease perception, and social support. Results A total of 364 participants were randomized (telemedicine group: 180, usual care group: 184). At 6 months, the telemedicine group exhibited a significantly greater reduction in SBP (-9.7 ± 16.5 mmHg) compared to the usual care group (-5.8 ± 16.8 mmHg; p=0.033). Similarly, DBP reductions were more pronounced in the telemedicine group (-4.2 ± 11.1 mmHg) than in the usual care group (-1.1 ± 11.8 mmHg; p=0.015). The telemedicine group also demonstrated improvements in BP control rates, medication adherence, and patient-reported quality of life. Exploratory analyses suggested enhanced patient engagement, better disease perception, and increased social support in the telemedicine group. Conclusion The SIMPLE study highlights that integrating SPC therapy with telemedicine and home BP monitoring significantly improves BP control compared to usual care. It also positively impacts medication adherence, quality of life, and psychological well-being, underscoring the potential of this simplified hypertension management strategy, particularly in resource-constrained settings.Study flow chart Main results
Maimaitiaili et al. (2025) conducted an RCT in Uncontrolled hypertension (n=364). Telemedicine, home BP monitoring, and single-pill combination therapy (SPC) vs. Usual care (conventional BP self-monitoring) was evaluated on Change in mean systolic BP (SBP) from baseline to 6 months (p=0.033). A simplified management model combining telemedicine, home BP monitoring, and single-pill combination therapy significantly reduced systolic BP compared to usual care (-9.7 vs -5.8 mmHg; p=0.033).