NCT06558877

Effect of a Pharmacist-led Multifaceted Intervention on Treatment Outcomes in Hypertensive Patients

Effect of a Pharmacist-led Multifaceted Intervention on Treatment Outcomes in Hypertensive Patients: a Cluster Randomised Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,200 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension

Interventions

Type	Name	Description
BEHAVIORAL	pharmacist-led multifaceted intervention	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.
BEHAVIORAL	conventional health education	The subjects receive conventional hypertension health education, standard blood pressure measurement training and regular follow-up in the control group.

Timeline

• Start date: 2025-06-20
• Primary completion: 2027-09-01
• Completion: 2027-12-31
• First posted: 2024-08-19
• Last updated: 2025-07-28

Locations

1 site across 1 country: China