Pharmacists Intervention to Improve Hypertension Management in Primary Care (APOTHECARE): A Cluster-randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 497
- 试验地点
- 106
- 主要终点
- Proportion of patients with systolic blood pressure <135 mmHg and diastolic blood pressure < 85 mmHg at 10 weeks of follow-up (automated office blood pressure measurement)
研究概览
简要总结
Arterial hypertension is the single largest contributor to mortality world-wide, and only 30-50% of diagnosed and treated patients achieve their blood pressure goal. The APOTHECARE trial is designed to identify treated patients with uncontrolled hypertension in community pharmacies in order to improve blood pressure control through intensification of antihypertensive therapy.
详细描述
Patients with medically treated arterial hypertension, who attend a pharmacy in order to obtain their antihypertensive medication are invited to participate in the trial.
The main inclusion criteria is uncontrolled hypertension, as determined by an automated office blood pressure measurement at a threshold of 135/85 mmHg.
Main exclusion criteria include a first-ever prescription of an antihypertensive agent, resistant hypertension, systolic blood pressure ≥ 180 mmHg and dialysis.
Randomization occurs on the level of pharmacies (cluster randomization).
Patients in the interventional arm are immediately referred to their treating physician for up-titration of antihypertensive therapy. Re-examination of automated automated office blood-pressure occurs in the respective pharmacy, and patients are referred to their treating physician again if required. These measures are accompanied by a structured and educational blood pressure record card.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Written informed consent
- •Age > 18 years
- •Medically pre-treated arterial hypertension
- •Automated office blood pressure ≥ 135 mmHg systolic or ≥ 85 mmHg diastolic
排除标准
- •First ever prescription of antihypertensive medication
- •First prescription of a new antihypertensive substance or dose adjustment
- •Prior therapy with 4 or more different antihypertensive substances
- •Systolic blood pressure ≥ 180 mmHg
- •Adherence to the study protocol not to be anticipated
- •Inclusion into the study at another study site
结局指标
主要结局
Proportion of patients with systolic blood pressure <135 mmHg and diastolic blood pressure < 85 mmHg at 10 weeks of follow-up (automated office blood pressure measurement)
时间窗: 10 weeks
Primary endpoint
次要结局
- Proportion of patients with systolic blood pressure <135 mmHg and diastolic blood pressure < 85 mmHg (automated office blood pressure measurement)(20 weeks)
- Proportion of patients with systolic blood pressure <135 mmHg and diastolic blood pressure < 85 mmHg (home blood pressure, mean of available readings)(20 weeks)
- Change in average systolic blood pressure (automated office blood pressure measurement)(20 weeks)
研究者
Miklos Rohla
MD
Wilhelminenspital Vienna