Efficacy of Pharmacist Interventions Through the "Medication Therapy Management Pathway in Hypertensive Patients":A Prospective, Multicenter, Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- systolic blood pressure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Intervention group
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.
干预措施: Structured drug therapy management (Behavioral)
Non-Intervention group
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.
结局指标
主要结局
systolic blood pressure
时间窗: 6 months
Change from baseline in mean seated systolic blood pressure at 6 months
次要结局
- Average number of medication-related problems (MRP) resolved after 6 months(6 months)
- diastolic blood pressure(6 months)
- Change from baseline in mean sitting systolic blood pressure at 3 months(3 months)
- Change from baseline in number of medication-related problems (MRP) at 6 months(6 months)
- The compliance rate of blood pressure after 6 months(6 months)
- Effective rate of blood pressure lowering after 6 months(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)
- Changes from baseline in adherence scores at 6 months,the General Medication Compliance Scale (GMAS) was used.(6 months)
- Economic indicators，mainly including the cost of implementing intervention measures and the impact of intervention measures on patient diagnosis and treatment costs(6 months)
研究者
Lin Yang
Professor
Beijing Anzhen Hospital