Clinical trial NCT06558877: Effect of a Pharmacist-led Multifaceted Intervention on Treatment Outcomes in Hypertensive Patients
Official title: Effect of a Pharmacist-led Multifaceted Intervention on Treatment Outcomes in Hypertensive Patients: a Cluster Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Zhengzhou University
name: Wuhan Union Hospital, China
name: Sichuan Academy of Medical Sciences
name: Zhejiang University
name: Second Affiliated Hospital of Xi'an Jiaotong University
name: The People's Hospital of Shaanxi Province
name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
First posted: 2024-08-19
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Blood pressure control rate
timeFrame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months after baseline
measure: Time in target range (TTR)
timeFrame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months after baseline
measure: Medication Adherence
timeFrame: baseline, 1 month, 3 months, 6 months and 12 months after baseline
measure: Cardiovascular events and all-cause death
timeFrame: baseline and 24 months after baseline
Secondary outcomes:
measure: Mean systolic and diastolic pressure changes
timeFrame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months after baseline
measure: Medication Appropriateness Index
timeFrame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months after baseline
measure: Body Mass Index (BMI)
timeFrame: baseline, 1 month, 3 months, 6 months and 12 months after baseline
measure: Alcohol consumption
timeFrame: baseline, 1 month, 3 months, 6 months and 12 months after baseline
measure: Nicotine consumption
timeFrame: baseline, 1 month, 3 months, 6 months and 12 months after baseline
measure: Medication Adherence
timeFrame: baseline and 24 months after baseline
measure: Patients' medical costs
timeFrame: baseline, 1 month, 3 months, 6 months and 12 months after baseline
measure: Hypertension-related adverse events rate
timeFrame: baseline and 24 months after baseline
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing hospital
state: Shaanxi
Study officials:
References: