A Home-based Blood Pressure Measurement Program in Hypertensive Patients to Promote Medications Adherence and Blood Pressure Status.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 2
- 主要终点
- Blood pressure-24 weeks
研究概览
简要总结
In this study the investigators aim to evaluate the effect of home-based blood pressure measurement with an electronic device on medication adherence and blood pressure control.
详细描述
Adherence to treatment is disappointingly low among patients with chronic health disorders especially after 6 month of initiating drug therapy. In hypertensive patients , as reported by WHO, 50% of non-adherence could be expected. Poor adherence to anti hypertensive medications results in increased morbidity, mortality and costs. One of the reasons that could implicate medications adherence can be attributed to seeing no physical sign of better controlling blood pressure. Self monitoring of blood pressure at home has been reported to improve patients adherence to their medications.
This study is a 2-arm randomized controlled trial. The investigators aim to evaluate the effect of home-based blood pressure measurement with an electronic device on medication adherence and blood pressure status.
One hundred ninety six hypertensive patients aged at least 18 years old are recruited in an ambulatory care setting and are evenly allocated to the study arms with balanced-block telephone randomization.
Appropriate medication is prescribed as preferred by the cardiologist (single daily dose medicines are recommended). Patients in both arms are followed for 24 weeks, each will be visited by the cardiologist four times during the study period. In each visit, patients' blood pressure will be measured twice by a nurse in the office.
In the intervention arm, electronic blood pressure device is provided for each patient and he/she will be trained to measure blood pressure at home once daily (same time each day). A logbook is also provided to document the daily blood pressure level.
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
- Single (Outcomes Assessor)
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
- •Ambulatory patients older than 18
- •Patients newly diagnosed as hypertension stage 1
- •Patients previously on antihypertensive treatment but uncontrolled hypertension
- •Patients not possessing electronic self blood pressure measurement device
- •Patients with functional ability to use the device
排除标准
- •Patients requiring two or more antihypertensive drugs at the start of the study
- •Patients with secondary hypertension
- •Patients cardiovascular comorbidities and other interfering medical conditions
- •Patients with drug contraindication or documented drug allergy
- •Patients with serum creatinine > 150 microliters
- •Withdrawal criteria:
- •Inadequate therapeutic effect requiring an increase of more than 20% in pre-established number of visits
- •Emergence of adverse drug reactions requiring cessation of medication
研究组 & 干预措施
Home-based blood pressure monitoring
干预措施: Self monitoring of blood pressure (Behavioral)
Usual care
干预措施: Usual Care (Other)
结局指标
主要结局
Blood pressure-24 weeks
时间窗: Change from baseline(at the point of recruiting) blood pressure at 24 weeks.
Blood pressure is measured twice by trained nurses using hand-cuff device at the physician office. (in Hg millimeter)
次要结局
- Medication adherence-4 weeks(Change from baseline(at the point of recruiting) medication adherence at 4 weeks)
- Blood pressure- 12 weeks(Change from baseline(at the point of recruiting) blood pressure at 12 weeks.)
- Blood pressure- 4 weeks(Change from baseline(at the point of recruiting) blood pressure at 4 weeks.)
- Medication adherence- 12 weeks(Change from baseline(at the point of recruiting) medication adherence at 12 weeks)
- Medication adherence-24 weeks(Change from baseline(at the point of recruiting) medication adherence at 24 weeks)