Effect of a Pharmacist-led Multifaceted Intervention on Treatment Outcomes in Hypertensive Patients: a Cluster Randomised Clinical Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hypertension
- Sponsor
- Xijing Hospital
- Enrollment
- 1200
- Locations
- 1
- Primary Endpoint
- Blood pressure control rate
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Wang Jingwen
Director of Pharmacy Department
Xijing Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Blood pressure control rate
Time Frame: 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
Time Frame: baseline and 24 months after baseline
Record cardiovascular events and all-cause death
Time in target range (TTR)
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)