Effectiveness of a mobile health app to support patient self-management of hypertension: a randomized controlled trial (Preprint)

BACKGROUND Hypertension is a significant global disease burden. Mobile health (mHealth) offers a promising means to provide hypertensive patients with easy access to healthcare services. Yet, its effectiveness needs to be validated, especially in less developed areas with a high-salt diet. OBJECTIVE This study aims to assess the effectiveness of the mHealth app-based intervention in supporting patient self-management of hypertension. METHODS A two-arm randomized controlled clinical trial was conducted on 448 patients with hypertension at the General Hospital of Ningxia Medical University, Ningxia Hui Autonomous Region, P.R.China. The participants selected via convenience sampling were randomly allocated into two groups: the intervention and control groups. Participants in the intervention group were trained and asked to use a mHealth app named Blood Pressure Assistant for six months. They can use the app to record and upload vital signs, access educational materials, and receive self-management reminders and feedback from healthcare providers based on the analysis of the uploaded data. Participants in the control group received the usual care. Blood pressure and two questionnaire surveys about hypertension knowledge and lifestyle behavior were used to assess all participants at baseline and six months. Data analysis was performed in SPSS software, using t-test and Chi-square test. RESULTS There were no differences in baseline characteristics between the two groups. After six months, although both groups show a significant pre-post improvement (P<.001; P<.001), the blood pressure control rate (i.e., the proportion of patients with systolic blood pressure <140mmHg and diastolic blood pressure <90mmHg) in the intervention group was better than that in the control group (90% vs. 65.6%, P<.001). The mean systolic blood pressure/diastolic blood pressure was significantly reduced by 25.83±8.99/14.28±3.74 mmHg in the intervention group (P<.001) and 21.83±6.86/8.87±4.22 mmHg in the control group (P<.001). The differences in systolic and diastolic blood pressure between the two groups were statistically significant (P<.001, P=.01). Hypertension knowledge was significantly improved only in the intervention group in both pre-post and inter-group comparisons (P<.001; P<0.01). However, only intra-group improvement was found for lifestyle behavior in the intervention group (P<.001), including medication adherence (P<.001), healthy diet (P=.024), low-salt intake (P<.001), and physical exercises (P=.017), and no significant difference in the control group and inter-group comparison. CONCLUSIONS This research demonstrated that the mHealth app-based intervention could effectively improve patient health knowledge and support them to self-manage towards a healthier lifestyle, including medication adherence, low-salt diets, and physical exercises, thereby achieving optimal blood pressure control. CLINICALTRIAL ChiCTR1900026437