| Objectives: High systolic blood pressure(SBP)is the leading risk factor for human deaths(10.8 million)worldwide,and 2.54 million people die from high SBP in China,of which 95.7% of patients die of cardiovascular disease.Despite the availability of five types of commonly effective antihypertensive drugs,the control rate and treatment control rate of hypertensive patients in China are 16.8% and 36.7%,respectively.The low rate of blood pressure(BP)control needs to be urgently addressed to reduce the disability and mortality rates of hypertensive complications.BP measurement is a fundamental method for assessing BP levels and for observing patients’ antihypertensive efficacy.Guidelines for hypertension recommend the use of home blood pressure monitoring(HBPM)for long-term follow-up management of patients.We aim to investigate the use of upper-arm electronic BP monitors in patients with hypertension in a community in urban Shanghai to analyze the status of HBPM and BP control as well as their influencing factors.Remote HBPM management studies have been shown to reduce the BP of patients,but the function and application need to be improved.Based on the results related to Chapter 1,we added three functions to the previous application that can promote patient perceived usefulness and clinical utility,and conducted an intervention trial combining online and offline management for patients with poor BP control in the community to analyze the effectiveness,safety,and feasibility Considering the differences in the focus of hypertension management between community general practitioners and hospital specialists,an intervention trial of online management of patients with poorly controlled BP in hospital outpatient clinics was conducted to develop a simplified BP home management model based on remote HBPM combined with telephonic remote guidance from physicians and antihypertensive titration regimen improving the effectiveness of BP control in patients while improving the efficiency of physician treatment,it will provide a reference for the promotion of remote HBPM management.Methods:(1)A cross-sectional study was conducted between May 2019 and January 2020 using a stratified random sampling method to select 1141 participants from hypertensive contracted patients in a community.A questionnaire was used to collect information on patient demographic characteristics,hypertension-related conditions,knowledge of HBPM,and the availability and use of HBPM.Descriptive analysis was performed using SPSS 23.0,and a multifactorial binary logistic regression was used to analyze the factors associated with HBPM behaviors affecting patients using a home upper-arm electronic BP monitor and BP control among patients.The constructed structural equation model of BP control status was validated using AMOS 24.0,including the goodness-of-fit test,the path coefficient test,and the effect size of each variable.(2)A 12-month randomized controlled trial(RCT)(September 2020 to February 2022)selected 270 participants with essential hypertension on oral antihypertensive medication and uncontrolled office BP in the community and patients were randomly assigned 1:1 to the intervention group(remote HBPM management)and the control group(self-monitoring combined with routine management).Relevant information was collected from patients at baseline,the 6th month,and the 12 th month.Statistics were performed according to the Intention-to-treat(ITT),comparing information on office BP-related indicators,home BP-related indicators,medication-related indicators,quality of life,and adverse events between the two groups,performing subgroup analysis of the decline in office SBP in patients according to age,sex and body mass index(BMI).The impact of the factors associated with office SBP was analyzed using a linear mixed-effects model(LMM),and sensitivity analysis was performed.(3)A 3-month RCT(January 2021 to February 2022)selected 304 participants with primary hypertension on oral antihypertensive medication and uncontrolled office BP in four hospitals,and patients were randomly assigned 1:1 to the intervention group(simplified home BP management)and the control group(self-monitoring combined with routine management).Relevant information was collected from patients at baseline and the3 rd month.Statistics were performed according to the ITT,comparing information on office BP-related indicators,home BP-related indicators,medication-related indicators,and adverse events between the two groups,performing subgroup analysis of the decline in office SBP in patients according to age,sex,and BMI.The impact of the factors associated with office SBP was analyzed using LMM,and sensitivity analysis was performed.Results:(1)The ownership rate of the upper-arm electronic BP monitor was58.19%(n=664),and 510 patients(44.70%)who used this type of BP monitor for HBPM for at least 1 day/week had it,and a total of 662 patients(58.02%)had their BP controlled.Logistic regression analysis showed that patients who knew the diagnostic criteria for hypertension with HBPM [Adjusted Odd Ratio(AOR)=1.42,95% Confidence Interval(CI): 1.05～1.91)],knew that HBPM with an upper-arm electronic BP monitor was best(AOR=2.55,95% CI: 1.95～3.34)and those who considered self-monitoring frequency to be at least 1 day/week(AOR=2.19,95% CI:1.45～3.30)had a higher rate of HBPM after adjusting for BMI,marriage,smoking,alcohol consumption,regular exercise,and high-salt diet.The results of the structural equation model showed that lifestyle(β=-0.24,P=0.008),hypertension-specific behavior(β=0.34,P=0.006),and age(β=-0.15,P<0.001)directly affected patients’ BP control,with hypertension-specific as including medication adherence and HBPM behavior.315 of 510 HBPM(61.76%)patients had BP control,and logistic regression analysis showed that the frequency of HBPM was considered to be 4～7 days/week(AOR=2.18,95% CI: 1.45～3.29),the time of HBPM was morning and/or evening(AOR=1.88,95% CI: 1.27～2.80)and moderate/good medication adherence(moderate AOR=1.78,95% CI: 1.11～2.88;good AOR=3.74,95% CI: 2.12～6.60)had higher rates of BP control after adjusting for age and BMI.(2)After 12 months of community intervention,a total of 244 participants completed follow-up(121 in the intervention group and 123 in the control group).In the 6th month,the defined daily doses(DDDs)and HBPM frequency increased more in the intervention group,and the office SBP and office mean arterial pressure(MAP)decreased more than in the control group(all P<0.05).In the 12 th month,the increase in medication type,DDDs,medication adherence,HBPM frequency,office BP control rate,and home BP control rate was greater in the intervention group,and the decrease in office SBP,office MAP,home SBP,and home MAP was greater than in the control group(all P<0.05).During the intervention period,office SBP,office pulse pressure(PP),office MAP,and office pulse pressure index(PPI)decreased more rapidly over time in the intervention group than in the control group(all P<0.05).Results from LMM showed that the interaction of time with the group(β=-1.17,P=0.001)indicated that the intervention group had a greater decrease in office SBP over time.Time(β=-6.50,P<0.001),DDDs(β=-0.82,P=0.016)and mean daily temperature(β=-0.33,P=0.001)were all negatively associated with office SBP,the degree of decline in office SBP was greater in patients with aged<65 years(β=-2.71,P=0.001),moderate/good medication adherence(moderate β=-2.46,good β=-4.01,both P<0.001)and HBPM frequency >3 days/week(β=-1.54,P<0.001)in the fixed effects.As shown by the random effects,the change in office SBP over time for different individuals was different.Sensitivity analysis showed that the model results were robust.There was no significant difference in the incidence of adverse events and information difficulties between the two groups(both P>0.05),and the intervention group was more in new dyslipidemia and satisfied with both the management system and BP management outcomes(all P<0.01).(3)After 3months of hospital outpatient intervention,a total of 292 participants completed follow-up(150 in the intervention group and 142 in the control group).In the 3rd month,the patients in the intervention group showed greater increases in medication type,DDDs,medication necessity beliefs,medication adherence,and HBPM frequency,and greater decreases in office SBP,office PP,office PPI,home SBP,the standard deviation of home SBP,home PP and home PPI than the control group(all P<0.05).The results of the model showed that the interaction between time and group(β=-2.76,P=0.001)indicated a greater decrease in office SBP over time in the intervention group.Time(β=-6.55,P<0.001),DDDs(β=-0.48,P=0.025),medication adherence(β=-0.35,P=0.024),and mean daily temperature(β=-0.21,P<0.001)were all negatively associated with office SBP,and patients with aged<65 years(β=-3.38,P<0.001)and HBPM frequency >3 days/week(β=-2.95,P=0.001)had a greater decrease in office SBP in the fixed effects.As indicated by the random effect,the change in office SBP over time for different individuals was different.Sensitivity analysis showed that the result was robust.There were no significant differences in the incidence of adverse events and information difficulties between the two groups during the period(all P > 0.05).Conclusions:(1)The rate of upper-arm home electronic blood pressure monitor ownership and HBPM were higher among hypertensive contracted patients of a community in urban Shanghai.BP control rates were higher in patients with good hypertension-specific behaviors.However,HBPM regimens of patients were mostly unreasonable and they are unable to take appropriate countermeasures against BP.The standardized guidance of family physicians and the Internet-based HBPM management may urge patients to actively self-monitoring to improve BP control.(2)Remote HBPM management contributed to a faster decline in office SBP,PP,MAP,and PPI in patients with poor BP control in the community and improved office BP control,DDDs,medication adherence,and HBPM frequency.The incidence of new-onset dyslipidemia was lower and satisfaction was higher in the intervention group,indicating that the management is effective,safe,and feasible,which can provide a basis for promoting a new model of hypertension management in the community.(3)Simplified BP home management contributed to significant reductions in office SBP,home SBP,and standard deviation of home SBP,and increased DDDs,medication necessity beliefs,medication adherence,and HBPM frequency in patients with uncontrolled BP.There were no differences in the incidence of adverse events and information difficulties among patients,but longer follow-up is needed to compare the incidence of adverse events.A health information integration platform should be built to support the three-level hypertension management system of "family-community-hospital" to further develop a sustainable remote HBMP management model. |
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