Recruiting
Effect of a Pharmacist-led Multifaceted Intervention on Treatment Outcomes in Hypertensive Patients
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.
ClinicalTrials.gov IDNCT06558877
PhaseNA
Enrollment1200
SponsorXijing Hospital
Age18 Years
SexALL
Conditions studied
Hypertension
About this study
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.
Interventions
- 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.
Primary outcomes
- Blood pressure control rate (baseline, 1 month, 3 months, 6 months, 12 months and 24 months after baseline)
- Time in target range (TTR) (baseline, 1 month, 3 months, 6 months, 12 months and 24 months after baseline)
- Medication Adherence (baseline, 1 month, 3 months, 6 months and 12 months after baseline)
- Cardiovascular events and all-cause death (baseline and 24 months after baseline)
Eligibility information
Inclusion Criteria (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
Exclusion Criteria(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.
Study locations
- Xijing hospital, Xi'an, Shaanxi 710032 China
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.