Effect of a Pharmacist-led Multifaceted Intervention on Treatment Outcomes in Hypertensive Patients
NCT Number: NCT06558877
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypertension
Interventions: BEHAVIORAL: pharmacist-led multifaceted intervention|BEHAVIORAL: conventional health education
Sponsor: Xijing Hospital
Collaborators: The First Affiliated Hospital of Zhengzhou University|Wuhan Union Hospital, China|Sichuan Academy of Medical Sciences|Zhejiang University|Second Affiliated Hospital of Xi'an Jiaotong University|The People's Hospital of Shaanxi Province|Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 800
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-09-01
Completion Date: 2026-12-31
Locations: Xijing hospital, Xi'an, Shaanxi, 710032, China

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.

Primary Outcome Measures: 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 Outcome Measures: Mean systolic and diastolic pressure changes, Mean systolic and diastolic pressure changes of participants, baseline, 1 month, 3 months, 6 months, 12 months and 24 months after baseline|Medication Appropriateness Index, Medication Appropriateness Index (MAI), assessed at baseline as well as at the 1, 3, 6 and 12 months follow-ups for each patient. The 10 items version of the MAI will be used, and the MAI score for each medication will range from 0 to 17. Higher scores indicate worse medication appropriateness., baseline, 1 month, 3 months, 6 months, 12 months and 24 months after baseline|Body Mass Index (BMI), Measure height and weight of subjects, and calculate BMI. Compare the change in BMI of subjects between the intervention group and the control group., baseline, 1 month, 3 months, 6 months and 12 months after baseline|Alcohol consumption, Record alcohol consumption by Alcohol Use Disorders Identification Test (AUDIT). The 10 items version of the AUDIT will be used, and AUDIT score will range from 0 to 40. Higher scores indicate greater alcohol dependence., baseline, 1 month, 3 months, 6 months and 12 months after baseline|Nicotine consumption, The smoking behavior, measured by fagerstrom test of nicotine dependence (FTND) scale in smoking patients from baseline to follow-up at 1, 3, 6 and 12 months. The 6 items version of the FTND will be used, and the FTND score will range from 0 to 10. Higher scores indicate greater nicotine dependence., baseline, 1 month, 3 months, 6 months and 12 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 and 24 months after baseline|Patients' medical costs, Comparison of the direct medical costs between the intervention and control groups during one year., baseline, 1 month, 3 months, 6 months and 12 months after baseline|Hypertension-related adverse events rate, Proportion of participants with hypertension-related adverse events (include hypotension, syncope, traumatic falls, bradycardia, electrolyte abnormalities, or acute kidney injury), baseline and 24 months after baseline