HypertensionPharmMTMHNCT06310512
Efficacy of Pharmacist Interventions Through the "Medication Therapy Management Pathway in Hypertensive Patients"
A study testing Structured drug therapy management in people with Hypertension and Medication Therapy Management, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
The goal of this Randomized Controlled Trial is to carry out in adult patients with primary hypertension whose blood pressure control is not up to standard. The main question it aims to answer are: To explore the effect of pharmacists' implementation of "the medication therapy management pathway in hypertensive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Medication Therapy Management
- What is being tested?
- Structured drug therapy management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old, male or female;
- Outpatients diagnosed with primary hypertension who have not received treatment or are receiving antihypertensive medication;
- Mild to moderate hypertensive patients with substandard blood pressure: home blood pressure >140/90 mmHg at least once in the last month or more, and the average sitting blood pressure in the clinic on the day of enrollment is >140/90 mmHg;
- Expected survival > 12 months;
- Voluntary participation in the trial and signing the informed consent form.
Who cannot join
- Severe hypertension (mean SBP ≥180mmHg, or mean DBP ≥110mmHg), hypertensive emergency or hypertensive sub-emergency (systolic blood pressure >180 mmHg or diastolic blood pressure >120 mmHg);
- Have a history or diagnosis of secondary hypertension, including but not limited to the following: renal hypertension, renal vascular hypertension, aortic stenosis, pheochromocytoma, Cushing's syndrome, cystic nephropathy, etc., but drug-induced hypertension is not an exclusion criterion;
- Patients in the acute stage of the disease requiring emergency medical consultation;
- patients with mental disorder, hearing impairment, intellectual disability, aphasia, etc., resulting in the inability to communicate or to comply with the study agreement
- Patients with tumors;
- Any other reasons that the investigator considers unsuitable for participation in the clinical trial that may affect the efficacy and safety evaluation of the study (including, but not limited to, the investigator's judgment that the subject lives far away and cannot be followed up as scheduled).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Pharmacist Interventions Through the "Medication Therapy Management Pathway in Hypertensive Patients":A Prospective, Multicenter, Randomized, Controlled Study
The goal of this Randomized Controlled Trial is to carry out in adult patients with primary hypertension whose blood pressure control is not up to standard. The main question it aims to answer are:
To explore the effect of pharmacists' implementation of "the medication therapy management pathway in hypertensive patients"on the patients with hypertension.
Read more
Participants will receive structured drug treatment management at the first diagnosis. During on-site follow-up in the first, third and sixth months, as well as telephone follow-up in the second week, second and fourth months, patients will be evaluated, corresponding information will be collected and possible interventions will be taken.
Researchers will compare the non intervention group to see if patients' blood pressure will also be reduced without intervention.
Read the detailed description
The purpose of this study is to explore the effectiveness, safety, and cost-effectiveness of pharmacists implementing the Drug Treatment Management Pathway in the treatment of hypertension patients. This trial is a prospective, multi-center, randomized, controlled study. We plan to enroll 420 patients with primary hypertension who are over 18 years old and whose blood pressure control is not up to standard. Qualified participants who meet the inclusion and exclusion criteria were randomly divided into an intervention group of 280 cases and a non intervention group of 140 cases in a 2:1 ratio.
- Conditions
- Hypertension, Medication Therapy Management
- Being tested
- Structured drug therapy management
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured drug therapy managementBehavioural
Interventions mainly included (1) information collection, clinical assessment, and evaluation of medication regimens; (2) identification of and intervention for medication-related problems; (3) pharmacy instruction and education, and development of personal medication lists; and (4) follow-up and reassessment
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention group patients will undergo structured drug treatment management at their first visit. During on-site follow-up at 1, 3, and 6 months, as well as telephone follow-up at the second week, 2 and 4 months, the patient's condition will be evaluated, corresponding information will be collected, and possible intervention measures will be taken for the patient. Receives: Behavioral: Structured drug therapy management |
| Non-Intervention group | No intervention | For non intervention group patients, pharmacists evaluate the patient's condition and collect corresponding information at the first visit and on-site follow-up at 1, 3, and 6 months, explain the dosage and dosage of drugs to the patient, and remind them of medication contraindications. Necessary intervention measures are taken at the 6th month. |
What is being measured
The primary outcome is the main question the study is designed to answer.
systolic blood pressure
Change from baseline in mean seated systolic blood pressure at 6 months
Measured: 6 months
Secondary outcomes (9)
diastolic blood pressure
Changes from baseline in mean seated diastolic blood pressure at 6 months
Measured: 6 months
Change from baseline in mean sitting systolic blood pressure at 3 months
Change from baseline in mean sitting systolic blood pressure at 3 months
Measured: 3 months
Change from baseline in number of medication-related problems (MRP) at 6 months
Change from baseline in number of medication-related problems (MRP) at 6 months
Measured: 6 months
Average number of medication-related problems (MRP) resolved after 6 months
Average number of medication-related problems (MRP) resolved after 6 months
Measured: 6 months
The compliance rate of blood pressure after 6 months
The compliance rate of blood pressure after 6 months
Measured: 6 months
Effective rate of blood pressure lowering after 6 months
Effective rate of blood pressure lowering after 6 months
Measured: 6 months
Time to BP Attainment in Intervention and Non-Intervention Groups
Time to BP Attainment in Intervention and Non-Intervention Groups
Measured: From the date of enrollment to the date when the patient's first blood pressure meets the standard, the evaluation is conducted up to 6 months
Changes from baseline in adherence scores at 6 months,the General Medication Compliance Scale (GMAS) was used.
The General Medication Compliance Scale (GMAS) was used, with a maximum score of 33 and a minimum score of 0. The higher the score, the higher the patient's compliance.
Measured: 6 months
Economic indicators，mainly including the cost of implementing intervention measures and the impact of intervention measures on patient diagnosis and treatment costs
The implementation costs of intervention measures mainly include the development, installation, and annual maintenance costs of Interactive Network Response System (IWRS), labor costs of intervention measures, material costs incurred during the intervention process, multi center collaboration costs, and other costs incurred due to the intervention measures. Intervention measures have an impact on patient diagnosis and treatment costs, mainly including an increase in per visit outpatient expenses and medication costs.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 May 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (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 Beijing Anzhen 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
- None (open label)
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Yang, Beijing Anzhen Hospital
- Investigators
- Yang Lin, Study director, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310512
- Sponsor's protocol ID
- ANZHEN HOSPITOL-LY-04
- Acronym
- PharmMTMH
- Status last verified
- Mar 2024
- First submitted
- 18 Dec 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pharmacist Interventions Through the "Medication Therapy Management Pathway in Hypertensive Patients":A Prospective, Multicenter, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT06310512
- Acronym / sponsor ID
- PharmMTMH / ANZHEN HOSPITOL-LY-04
- Conditions
- Hypertension, Medication Therapy Management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 15 Mar 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 goal of this Randomized Controlled Trial is to carry out in adult patients with primary hypertension whose blood pressure control is not up to standard. The main question it aims to answer are:
To explore the effect of pharmacists' implementation of "the medication therapy management pathway in hypertensive patients"on the patients with hypertension.
Participants will receive structured drug treatment management at the first diagnosis. During on-site follow-up in the first, third and sixth months, as well as telephone follow-up in the second week, second and fourth months, patients will be evaluated, corresponding information will be collected and possible interventions will be taken.
Researchers will compare the non intervention group to see if patients' blood pressure will also be reduced without intervention.
Detailed description
The purpose of this study is to explore the effectiveness, safety, and cost-effectiveness of pharmacists implementing the Drug Treatment Management Pathway in the treatment of hypertension patients. This trial is a prospective, multi-center, randomized, controlled study. We plan to enroll 420 patients with primary hypertension who are over 18 years old and whose blood pressure control is not up to standard. Qualified participants who meet the inclusion and exclusion criteria were randomly divided into an intervention group of 280 cases and a non intervention group of 140 cases in a 2:1 ratio.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Structured drug therapy managementIntervention group patients will undergo structured drug treatment management at their first visit. During on-site follow-up at 1, 3, and 6 months, as well as telephone follow-up at the second week, 2 and 4 months, the patient's condition will be evaluated, corresponding information will be collected, and possible intervention measures will be taken for the patient. |
| Non-Intervention group | No intervention | –For non intervention group patients, pharmacists evaluate the patient's condition and collect corresponding information at the first visit and on-site follow-up at 1, 3, and 6 months, explain the dosage and dosage of drugs to the patient, and remind them of medication contraindications. Necessary intervention measures are taken at the 6th month. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years old, male or female;
- Outpatients diagnosed with primary hypertension who have not received treatment or are receiving antihypertensive medication;
- Mild to moderate hypertensive patients with substandard blood pressure: home blood pressure >140/90 mmHg at least once in the last month or more, and the average sitting blood pressure in the clinic on the day of enrollment is >140/90 mmHg;
- Expected survival > 12 months;
- Voluntary participation in the trial and signing the informed consent form.
Key exclusion criteria (6 listed)
- Severe hypertension (mean SBP ≥180mmHg, or mean DBP ≥110mmHg), hypertensive emergency or hypertensive sub-emergency (systolic blood pressure >180 mmHg or diastolic blood pressure >120 mmHg);
- Have a history or diagnosis of secondary hypertension, including but not limited to the following: renal hypertension, renal vascular hypertension, aortic stenosis, pheochromocytoma, Cushing's syndrome, cystic nephropathy, etc., but drug-induced hypertension is not an exclusion criterion;
- Patients in the acute stage of the disease requiring emergency medical consultation;
- patients with mental disorder, hearing impairment, intellectual disability, aphasia, etc., resulting in the inability to communicate or to comply with the study agreement
- Patients with tumors;
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 |
|---|---|---|
| Structured drug therapy managementInterventions mainly included (1) information collection, clinical assessment, and evaluation of medication regimens; (2) identification of and intervention for medication-related problems; (3) pharmacy instruction and education, and development of personal medication lists; and (4) follow-up and reassessment | Behavioural | Intervention group |
Primary outcome
systolic blood pressure
Time frame: 6 months
Change from baseline in mean seated systolic blood pressure at 6 months
9 secondary outcomes
diastolic blood pressure
Time frame: 6 months
Change from baseline in mean sitting systolic blood pressure at 3 months
Time frame: 3 months
Change from baseline in number of medication-related problems (MRP) at 6 months
Time frame: 6 months
Average number of medication-related problems (MRP) resolved after 6 months
Time frame: 6 months
The compliance rate of blood pressure after 6 months
Time frame: 6 months
Effective rate of blood pressure lowering after 6 months
Time frame: 6 months
Time to BP Attainment in Intervention and Non-Intervention Groups
Time frame: From the date of enrollment to the date when the patient's first blood pressure meets the standard, the evaluation is conducted up to 6 months
Changes from baseline in adherence scores at 6 months,the General Medication Compliance Scale (GMAS) was used.
Time frame: 6 months
Economic indicators，mainly including the cost of implementing intervention measures and the impact of intervention measures on patient diagnosis and treatment costs
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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. This study is not recruiting at the moment.
Yang Lin study director
Beijing Anzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured drug therapy management in people with Hypertension and Medication Therapy Management, run by Beijing Anzhen 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?
The sponsor lists 5 inclusion and 6 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 15 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JuanJuan Wei, MS (01064456609, weijj2005@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
systolic blood pressure (time frame: 6 months). 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 15 Mar 2024.