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

NCT06558877 | Recruiting

• 1 other identifier: KY20242276
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (4)

• Blood pressure control rate

  The proportion of participants with controlled blood pressure

  baseline, 1 month, 3 months, 6 months, 12 months and 24 months after baseline

• Time in target range (TTR)

  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.

  baseline, 1 month, 3 months, 6 months, 12 months and 24 months after baseline

• Medication Adherence

  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.

  baseline, 1 month, 3 months, 6 months and 12 months after baseline

• Cardiovascular events and all-cause death

  Record cardiovascular events and all-cause death

  baseline and 24 months after baseline

Secondary Outcomes (8)

• Mean systolic and diastolic pressure changes

  baseline, 1 month, 3 months, 6 months, 12 months and 24 months after baseline

• Medication Appropriateness Index

  baseline, 1 month, 3 months, 6 months, 12 months and 24 months after baseline

• Body Mass Index (BMI)

  baseline, 1 month, 3 months, 6 months and 12 months after baseline

• Alcohol consumption

  baseline, 1 month, 3 months, 6 months and 12 months after baseline

• Nicotine consumption

  baseline, 1 month, 3 months, 6 months and 12 months after baseline

Study Arms (2)

intervention group

EXPERIMENTAL

Behavioral: pharmacist-led multifaceted intervention

control group

OTHER

Behavioral: conventional health education

Interventions

pharmacist-led multifaceted intervention BEHAVIORAL

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.

intervention group

conventional health education BEHAVIORAL

The subjects receive conventional hypertension health education, standard blood pressure measurement training and regular follow-up in the control group.

control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) age 18-80 years;
• \) 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;
• \) able to use smartphones and WeChat proficiently, and can communicate and upload pictures proficiently;
• \) able to take care of yourself and communicate normally, and willing to cooperate with the research physician to complete the study and follow-up;
• \) permanent residents of the city where the center is located;
• \) voluntarily participate and sign the informed consent form

You may not qualify if:

• \) 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;
• \) combined with psychiatric disease, cognitive impairment, communication disorder, or inability to cooperate with the researchers;
• \) combined with cerebrovascular disease, stroke, severe liver and kidney dysfunction, severe heart failure, cancer and history of organ transplantation, etc.;
• \) patients who are pregnant, breastfeeding, or planning to conceive in the next 2 years.

Sponsors & Collaborators

• Xijing Hospital: lead
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Sichuan Academy of Medical Sciences: collaborator
• Zhejiang University: collaborator
• Second Affiliated Hospital of Xi'an Jiaotong University: collaborator
• The People's Hospital of Shaanxi Province: collaborator
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Tang-Du Hospital: collaborator
• LanZhou University: collaborator

Study Sites (1)

Xijing hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Qianqian Dong, Doctor

CONTACT

+8613720451039; dongqq@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Pharmacy Department

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 19, 2024
• Study Start: June 20, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 28, 2025

Record last verified: 2025-07

Locations

CN (1)