Hypertension, Medication Therapy Management
Conditions
Brief 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 patientson 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.
Interventions
BEHAVIORALStructured drug therapy management
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
Sponsors
Beijing Anzhen Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years old, male or female; 2. Outpatients diagnosed with primary hypertension who have not received treatment or are receiving antihypertensive medication; 3. 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; 4. Expected survival \> 12 months; 5. Voluntary participation in the trial and signing the informed consent form.
Exclusion criteria
1. 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); 2. 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; 3. Patients in the acute stage of the disease requiring emergency medical consultation; 4. patients with mental disorder, hearing impairment, intellectual disability, aphasia, etc., resulting in the inability to communicate or to comply with the study agreement 5. Patients with tumors; 6. 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| systolic blood pressure | 6 months | Change from baseline in mean seated systolic blood pressure at 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in mean sitting systolic blood pressure at 3 months | 3 months | Change from baseline in mean sitting systolic blood pressure at 3 months |
| Change from baseline in number of medication-related problems (MRP) at 6 months | 6 months | Change from baseline in number of medication-related problems (MRP) at 6 months |
| Average number of medication-related problems (MRP) resolved after 6 months | 6 months | Average number of medication-related problems (MRP) resolved after 6 months |
| The compliance rate of blood pressure after 6 months | 6 months | The compliance rate of blood pressure after 6 months |
| diastolic blood pressure | 6 months | Changes from baseline in mean seated diastolic blood pressure at 6 months |
| Time to BP Attainment in Intervention and Non-Intervention Groups | 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 | Time to BP Attainment in Intervention and Non-Intervention Groups |
| Changes from baseline in adherence scores at 6 months,the General Medication Compliance Scale (GMAS) was used. | 6 months | 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. |
| Economic indicators，mainly including the cost of implementing intervention measures and the impact of intervention measures on patient diagnosis and treatment costs | 6 months | 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. |
| Effective rate of blood pressure lowering after 6 months | 6 months | Effective rate of blood pressure lowering after 6 months |
Countries
China
Contacts
Primary ContactJuanJuan Wei, MS
Outcome results
None listed