Effect of a Pharmacist-led Multifaceted Intervention on Treatment Outcomes in Hypertensive Patients
NCT ID: NCT06558877
Last Updated: 2025-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1200 participants
INTERVENTIONAL
2025-06-20
2027-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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intervention group
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.
control group
conventional health education
The subjects receive conventional hypertension health education, standard blood pressure measurement training and regular follow-up in the control group.
Interventions
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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.
conventional health education
The subjects receive conventional hypertension health education, standard blood pressure measurement training and regular follow-up in the control group.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Zhengzhou University
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Sichuan Academy of Medical Sciences
OTHER
Zhejiang University
OTHER
Second Affiliated Hospital of Xi'an Jiaotong University
OTHER
The People's Hospital of Shaanxi Province
UNKNOWN
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Tang-Du Hospital
OTHER
LanZhou University
OTHER
Xijing Hospital
OTHER
Responsible Party
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Wang Jingwen
Director of Pharmacy Department
Locations
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Xijing hospital
Xi'an, Shaanxi, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KY20242276
Identifier Type: -
Identifier Source: org_study_id
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