Mobile Health Applications For The Management Of Primary Hypertension:A Multi-Center,Randomized,Controlled Trial

Background: Hypertension is a leading risk factor for cardiovascular and cerebrovascular diseases.Some researches have found that mobile health applications may be effective for blood control.But these results lack multi-center studies with larger sample size to prove.So we design this multi-center,randomized,controlled trial to explore the function of APP.Objective: The purpose of the study was to assess the impact of the m-Health APPs on blood pressure、medication adherence and the incidence of MACCEs.Methods: 18 to 79 year-old patients with Primary hypertension were enrolled in the multi-center randomized controlled clinical trial.480 participants were randomly assigned to the intervention and control groups.The intervention group used the “Yan FU” APP to manage the blood pressure,the control group didn’t use any m-Health APP.The outcomes were changes in blood pressure and percentage of participants with blood pressure under control、the incidence of MACCEs and medication adherence at month 6.Results: At the end of the study,37 participants were lost to follow up.The final analysis included 443 participants.The intervention group had 225 participants and control group had 218 participants.The baseline characteristics(sex、age、BMI、family history、duration of hypertension、smoking、diabetes、coronary heart disease、hyperlipidemia、SBP、DBP and the percentage of patients with controlled blood pressure)between the two groups had no statistical significance(P>0.05).At month 6,All the participants of the two groups had lower average SBP and DBP than the baseline of the trial,the p values were less than 0.05.The intervention group had lower systolic and diastolic blood pressure than the start [(131.52±7.066mmHg)vs(140.51±10.447mmHg)]and[(76.86±7.236mmHg)vs(83.89± 8.618mmHg)(P=0.00).The control group had lower systolic and diastolic blood pressure than the start [(135.27±8.094mmHg)vs(141.19 ±10.116mmHg)] and [(78.44±8.237mmHg)vs(82.59±9.621mmHg)](P=0.00).At the same time,the intervention group had a greater change in SBP than the control group.[(-8.99±6.415mmHg)vs(-5.92±6.945mmHg)](P =0.00).The intervention group also had a greater change in DBP than the control group [(-7.04±6.135mmHg)vs(-4.14±8.213mmHg)]((P=0.00).The percentage of the participants in the two groups with controlled blood pressure were improved(P=0.00),but the intervention group had a greater controll rate of blood pressure than the control group at the end of the trial(P=0.011).The incidence of MACCEs between the two groups had no statistically significant differences(P=0.242).The medication adherence of the intervention group was higher than the control group which had statistically significance(P=0.004).Conclusion: m-Health APPs are effective for hypertension management.Maybe m-Health APPs can be promoted to apply in the national hypertension control plan.But we still need larger-scale studies with longer duration and more scientific randomized ways to prove the value of m-Health APPs.