Effect of a Pharmacist-led Multifaceted Intervention on Treatment Outcomes in Hypertensive Patients: a Cluster Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Blood pressure control rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(subjects must meet all of the following criteria to be included):
- •1) age 18-80 years;
- •2) patients with hypertension (diagnostic criteria: defined as systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg according to the "Guidelines for the prevention and treatment of hypertension in China in 2023", based on the blood pressure measurement of three times on different days), who are currently taking anti-hypertensive medication and are judged by the research physician to have poor blood pressure control;
- •3) able to use smartphones and WeChat proficiently, and can communicate and upload pictures proficiently;
- •4) able to take care of yourself and communicate normally, and willing to cooperate with the research physician to complete the study and follow-up;
- •5) permanent residents of the city where the center is located;
- •6) voluntarily participate and sign the informed consent form
排除标准
- •(subjects will be excluded if they meet any of the following criteria):
- •1) patients with advanced disease (such as patients undergoing dialysis or liver failure), or with a life expectancy of less than 2 years as determined by the research physician;
- •2) combined with psychiatric disease, cognitive impairment, communication disorder, or inability to cooperate with the researchers;
- •3) combined with cerebrovascular disease, stroke, severe liver and kidney dysfunction, severe heart failure, cancer and history of organ transplantation, etc.;
- •4) patients who are pregnant, breastfeeding, or planning to conceive in the next 2 years.
结局指标
主要结局
Blood pressure control rate
时间窗: baseline, 1 month, 3 months, 6 months, 12 months and 24 months after baseline
The proportion of participants with controlled blood pressure
Cardiovascular events and all-cause death
时间窗: baseline and 24 months after baseline
Record cardiovascular events and all-cause death
Time in target range (TTR)
时间窗: baseline, 1 month, 3 months, 6 months, 12 months and 24 months after baseline
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.
Medication Adherence
时间窗: baseline, 1 month, 3 months, 6 months and 12 months after baseline
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.
次要结局
- Alcohol consumption(baseline, 1 month, 3 months, 6 months and 12 months after baseline)
- Patients' medical costs(baseline, 1 month, 3 months, 6 months and 12 months after baseline)
- Nicotine consumption(baseline, 1 month, 3 months, 6 months and 12 months after baseline)
- Mean systolic and diastolic pressure changes(baseline, 1 month, 3 months, 6 months, 12 months and 24 months after baseline)
- Medication Appropriateness Index(baseline, 1 month, 3 months, 6 months, 12 months and 24 months after baseline)
- Body Mass Index (BMI)(baseline, 1 month, 3 months, 6 months and 12 months after baseline)
- Medication Adherence(baseline and 24 months after baseline)
- Hypertension-related adverse events rate(baseline and 24 months after baseline)
研究者
Wang Jingwen
Director of Pharmacy Department
Xijing Hospital