A Home-based Blood Pressure Monitoring Program to Promote Better Management of Hypertension
A Home-based Blood Pressure Measurement Program in Hypertensive Patients to Promote Medications Adherence and Blood Pressure Status.
研究概览
详细说明
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.
Primary outcome of the study is the blood pressure measured at each office visit overtime. Medication adherence is measured by pill count method as the secondary outcome.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Tehran、伊朗伊斯兰共和国
- Dr Mohagheghi's Office
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Home-based blood pressure monitoring
|
Electronic blood pressure device is provided for patients 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.
|
|
有源比较器：日常护理
|
Four visits to the physician's office at 4th, 12th, 24th week in the study period with usual advice giving practice of the staff.
At the end of the trial period, an electronic blood pressure device will be given to each patient in this arm.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Blood pressure-24 weeks
大体时间：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)
|
Change from baseline(at the point of recruiting) blood pressure at 24 weeks.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Medication adherence-4 weeks
大体时间：Change from baseline(at the point of recruiting) medication adherence at 4 weeks
|
Change from baseline(at the point of recruiting) medication adherence at 4 weeks
|
|
|
Blood pressure- 4 weeks
大体时间：Change from baseline(at the point of recruiting) blood pressure at 4 weeks.
|
Change from baseline(at the point of recruiting) blood pressure at 4 weeks.
|
|
|
Blood pressure- 12 weeks
大体时间：Change from baseline(at the point of recruiting) blood pressure at 12 weeks.
|
Change from baseline(at the point of recruiting) blood pressure at 12 weeks.
|
|
|
Medication adherence- 12 weeks
大体时间：Change from baseline(at the point of recruiting) medication adherence at 12 weeks
|
Change from baseline(at the point of recruiting) medication adherence at 12 weeks
|
|
|
Medication adherence-24 weeks
大体时间：Change from baseline(at the point of recruiting) medication adherence at 24 weeks
|
Pill count method is employed.
At the time of each office visit, patients bring their medications with themselves and the researcher counts the unused pills.
Adherence is calculated as percentage of the pills used during previous weeks.
|
Change from baseline(at the point of recruiting) medication adherence at 24 weeks
|
合作者和调查者
调查人员
- 学习椅：Kheirollah Gholami, M.Sc,PharmD、Tehran University of Medical Sciences
- 研究主任：Zahra Jahangard-Rafsanjani, PharmD、Tehran University of Medical Sciences
- 首席研究员：Arash Rashidian, M.D, Ph.D、Tehran University of Medical Sciences
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.