The objective of this cluster randomized controlled trial is to evaluate the effectiveness of a pharmacist-led multifaceted intensive blood pressure intervention on poorly controlled hypertensive patients in phase 1 (1 month, 3 months, 6 months, 12 months) and phase 2 (24 months) post randomization.
This cluster randomized trial is conducted in eight tertiary hospitals of China, and we planned to enroll 100 participants at each hospital. The eight hospitals will be randomly divided into an intervention group or a control group in a 1:1 ratio. A total of 800 patients with poorly controlled blood pressure aged 18-80 years will be recruited into the study. The pharmacist-led multifaceted intervention is comprised of all the following five components: 1) Health education: lectures on hypertension related knowledge, the potential risks of hypertension, and guidance on healthy lifestyle, etc; 2) home blood pressure telemonitoring; 3) Medication consultation: including the usage, dosage, precautions and adverse reactions of hypertension drugs; 4) Medication reminders: remind subjects to take medication on time by Wechat or Messages; 5) Formulation of individualized medication regimen: efficacy evaluation and drug realignment. However, the control group received routine hypertension health education, standardized blood pressure measurement and regular follow-up. The primary outcome is to assess the change in blood pressure control rate, time in target range (TTR), adherence to antihypertensive medication rate, and cardiovascular disease (CVDs) between the intervention group and the control group from baseline to follow-up at 1 month, 3 months, 6 months, 12 and 24 months post randomization. The secondary outcome is to assess the change in the mean systolic and diastolic pressures, and the medication appropriateness measured by the medication appropriateness index (MAI) between the two groups in phase 1 and 2. Meanwhile, the BMI, alcohol use and smoking will be also assessed in phase 1, and the incidence of hypertension-related adverse events will be assessed in phase 2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
1,200
Based on the blood pressure management model of pharmacist-led multifaceted intervention, clinical pharmacists who have received unified training provide pharmaceutical intervention and lifestyle guidance to subjects in the intervention group according to standard protocol. Pharmaceutical interventions include health education, medication adherence (medication consultation, medication reminder), medication reorganization, and rational use of medication. At the same time, clinical pharmacists supervise the subjects to change their lifestyle (including reasonable diet, quitting smoking and drinking, moderate exercise, weight control and ensuring sleep, etc.), and guide the subjects to conduct home blood pressure monitoring.
The subjects receive conventional hypertension health education, standard blood pressure measurement training and regular follow-up in the control group.
Xijing hospital
Xi'an, Shaanxi, China
RECRUITINGBlood pressure control rate
The proportion of participants with controlled blood pressure
Time frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months after baseline
Time in target range (TTR)
TTR is the proportion of time that a subject's blood pressure value is within the specified target blood pressure range, which reflects the average blood pressure (BP) value and the degree of blood pressure variability during long-term follow-up.
Time frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months after baseline
Medication Adherence
The Morisky Medication Adherence Scale is used for evaluating the medication adherence. Compare the change in medication adherence between the intervention group and the control group. The 8 items version of the Morisky will be used, and Morisky score will range from 0 to 8. Higher scores indicate better medication adherence.
Time frame: baseline, 1 month, 3 months, 6 months and 12 months after baseline
Cardiovascular events and all-cause death
Record cardiovascular events and all-cause death
Time frame: baseline and 24 months after baseline
Mean systolic and diastolic pressure changes
Mean systolic and diastolic pressure changes of participants
Time frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months after baseline
Medication Appropriateness Index
Medication Appropriateness Index (MAI), assessed at baseline as well as at the 1, 3, 6 and 12 months follow-ups for each patient. The 10 items version of the MAI will be used, and the MAI score for each medication will range from 0 to 17. Higher scores indicate worse medication appropriateness.
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Time frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months after baseline
Body Mass Index (BMI)
Measure height and weight of subjects, and calculate BMI. Compare the change in BMI of subjects between the intervention group and the control group.
Time frame: baseline, 1 month, 3 months, 6 months and 12 months after baseline
Alcohol consumption
Record alcohol consumption by Alcohol Use Disorders Identification Test (AUDIT). The 10 items version of the AUDIT will be used, and AUDIT score will range from 0 to 40. Higher scores indicate greater alcohol dependence.
Time frame: baseline, 1 month, 3 months, 6 months and 12 months after baseline
Nicotine consumption
The smoking behavior, measured by fagerstrom test of nicotine dependence (FTND) scale in smoking patients from baseline to follow-up at 1, 3, 6 and 12 months. The 6 items version of the FTND will be used, and the FTND score will range from 0 to 10. Higher scores indicate greater nicotine dependence.
Time frame: baseline, 1 month, 3 months, 6 months and 12 months after baseline
Medication Adherence
The Morisky Medication Adherence Scale is used for evaluating the medication adherence. Compare the change in medication adherence between the intervention group and the control group. The 8 items version of the Morisky will be used, and Morisky score will range from 0 to 8. Higher scores indicate better medication adherence.
Time frame: baseline and 24 months after baseline
Patients' medical costs
Comparison of the direct medical costs between the intervention and control groups during one year.
Time frame: baseline, 1 month, 3 months, 6 months and 12 months after baseline
Hypertension-related adverse events rate
Proportion of participants with hypertension-related adverse events (include hypotension, syncope, traumatic falls, bradycardia, electrolyte abnormalities, or acute kidney injury)
Time frame: baseline and 24 months after baseline