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| Name | Class |
|---|---|
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | OTHER |
| Sichuan Academy of Medical Sciences | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention group | Experimental |
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| control group | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pharmacist-led multifaceted intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure control rate | The proportion of participants with controlled blood pressure | 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. | 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. | 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 | baseline and 24 months after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Mean systolic and diastolic pressure changes | Mean systolic and diastolic pressure changes of participants | baseline, 1 month, 3 months, 6 months, 12 months and 24 months after baseline |
| Medication Appropriateness Index |
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Inclusion Criteria (subjects must meet all of the following criteria to be included):
Exclusion Criteria(subjects will be excluded if they meet any of the following criteria):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qianqian Dong, Doctor | Contact | +8613720451039 | dongqq@fmmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing hospital | Recruiting | Xi'an | Shaanxi | 710032 | China |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Zhejiang University | OTHER |
| Second Affiliated Hospital of Xi'an Jiaotong University | OTHER |
| Shaanxi Provincial People's Hospital | OTHER |
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| Tang-Du Hospital | OTHER |
| LanZhou University | OTHER |
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| conventional health education | Behavioral | The subjects receive conventional hypertension health education, standard blood pressure measurement training and regular follow-up in the control group. |
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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.
| 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. | 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. | 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. | 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. | baseline and 24 months after baseline |
| Patients' medical costs | Comparison of the direct medical costs between the intervention and control groups during one year. | 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) | baseline and 24 months after baseline |