HypertensionNCT06558877
Effect of a Pharmacist-led Multifaceted Intervention on Treatment Outcomes in Hypertensive Patients
A study testing pharmacist-led multifaceted intervention and conventional health education in people with Hypertension, run by Xijing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- pharmacist-led multifaceted intervention and conventional health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xijing hospital
Xi'an, Shaanxi, 710032
Qianqian Dong, Doctor, +8613720451039, dongqq@fmmu.edu.cn
About this study
Official title: Effect of a Pharmacist-led Multifaceted Intervention on Treatment Outcomes in Hypertensive Patients: a Cluster Randomised Clinical Trial
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- pharmacist-led multifaceted intervention, conventional health education
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pharmacist-led multifaceted interventionBehavioural
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 educationBehavioural
The subjects receive conventional hypertension health education, standard blood pressure measurement training and regular follow-up in the control group.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Not described Receives: Behavioral: pharmacist-led multifaceted intervention |
| control group | Other | Not described Receives: Behavioral: conventional health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure control rate
The proportion of participants with controlled blood pressure
Measured: 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.
Measured: 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.
Measured: 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
Measured: baseline and 24 months after baseline
Secondary outcomes (8)
Mean systolic and diastolic pressure changes
Mean systolic and diastolic pressure changes of participants
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline and 24 months after baseline
Patients' medical costs
Comparison of the direct medical costs between the intervention and control groups during one year.
Measured: 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)
Measured: baseline and 24 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start20 Jun 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Sichuan Academy of Medical Sciences, Second Affiliated Hospital, Zhejiang University, School of Medicine, Second Affiliated Hospital of Xi'an Jiaotong University, Shaanxi Provincial People's Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Tang-Du Hospital, LanZhou University
- Responsible party
- Principal investigator, Wang Jingwen, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558877
- Sponsor's protocol ID
- KY20242276
- Status last verified
- Jul 2025
- First submitted
- 14 Aug 2024
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Pharmacist-led Multifaceted Intervention on Treatment Outcomes in Hypertensive Patients: a Cluster Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT06558877
- Acronym / sponsor ID
- KY20242276
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Sichuan Academy of Medical Sciences, Second Affiliated Hospital, Zhejiang University, School of Medicine, Second Affiliated Hospital of Xi'an Jiaotong University, Shaanxi Provincial People's Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Tang-Du Hospital, LanZhou University
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: pharmacist-led multifaceted intervention |
| control group | Other | Behavioral: conventional health education |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pharmacist-led multifaceted interventionBased 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. | Behavioural | intervention group |
| conventional health educationThe subjects receive conventional hypertension health education, standard blood pressure measurement training and regular follow-up in the control group. | Behavioural | control group |
Primary outcome
Blood pressure control rate
Time frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months after baseline
The proportion of participants with controlled blood pressure
Time in target range (TTR)
Time frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months after baseline
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.
Medication Adherence
Time frame: baseline, 1 month, 3 months, 6 months and 12 months after baseline
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.
Cardiovascular events and all-cause death
Time frame: baseline and 24 months after baseline
Record cardiovascular events and all-cause death
8 secondary outcomes
Mean systolic and diastolic pressure changes
Time frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months after baseline
Medication Appropriateness Index
Time frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months after baseline
Body Mass Index (BMI)
Time frame: baseline, 1 month, 3 months, 6 months and 12 months after baseline
Alcohol consumption
Time frame: baseline, 1 month, 3 months, 6 months and 12 months after baseline
Nicotine consumption
Time frame: baseline, 1 month, 3 months, 6 months and 12 months after baseline
Medication Adherence
Time frame: baseline and 24 months after baseline
Patients' medical costs
Time frame: baseline, 1 month, 3 months, 6 months and 12 months after baseline
Hypertension-related adverse events rate
Time frame: baseline and 24 months after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pharmacist-led multifaceted intervention and conventional health education in people with Hypertension, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qianqian Dong, Doctor (+8613720451039, dongqq@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure control rate (time frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months after baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.