Effect of a Pharmacist-led Multifaceted Intervention on Treatment Outcomes in Hypertensive Patients
- Conditions
- Hypertension
- Interventions
- Behavioral: pharmacist-led multifaceted interventionBehavioral: conventional health education
- Registration Number
- NCT06558877
- Lead Sponsor
- Xijing Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 800
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description intervention group pharmacist-led multifaceted intervention - control group conventional health education -
- Primary Outcome Measures
Name Time Method Blood pressure control rate 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 baseline and 24 months after baseline Record cardiovascular events and all-cause death
Time in target range (TTR) 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 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 Outcome Measures
Name Time Method Alcohol consumption baseline, 1 month, 3 months, 6 months and 12 months after baseline 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.
Patients' medical costs baseline, 1 month, 3 months, 6 months and 12 months after baseline Comparison of the direct medical costs between the intervention and control groups during one year.
Nicotine consumption baseline, 1 month, 3 months, 6 months and 12 months after baseline 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.
Mean systolic and diastolic pressure changes baseline, 1 month, 3 months, 6 months, 12 months and 24 months after baseline Mean systolic and diastolic pressure changes of participants
Medication Appropriateness Index baseline, 1 month, 3 months, 6 months, 12 months and 24 months after baseline 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.
Body Mass Index (BMI) baseline, 1 month, 3 months, 6 months and 12 months after baseline Measure height and weight of subjects, and calculate BMI. Compare the change in BMI of subjects between the intervention group and the control group.
Medication Adherence baseline and 24 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.
Hypertension-related adverse events rate baseline and 24 months after baseline Proportion of participants with hypertension-related adverse events (include hypotension, syncope, traumatic falls, bradycardia, electrolyte abnormalities, or acute kidney injury)
Trial Locations
- Locations (1)
Xijing hospital
🇨🇳Xi'an, Shaanxi, China