Treatment of Hypertension: an Interventional Approach to Improve Blood Pressure Control (DRIVE)
研究概览
详细说明
More than 1 billion people world wide suffer from hypertension (HT), leaving it the world´s top rank risk factor and contributor to global disease burden. Cardiac disease, stroke, kidney disease and dementia are diseases related to HT with high economic burden on societies and each year 9.4 million people die as a direct consequence of HT.
Estimated < 50 % of hypertensive patients adhere to preventive hypertensive medication after 1 year of treatment.
Poor adherence to antihypertensive treatment have by many been explained partly by the silent nature of hypertension, the risk of side effects from antihypertensive medication, treatment expenditures and the patient health perspectives.
In a randomized controlled trial design we plan to enrol 20 subjects, the limited number explained by the study being part of the initial planning of a larger scale trial organized by the research group, to invistigate the change in ambulatory bloodpressure with or with out Direct Observed Theraphy prior to meassurement, as a one-time-only medication adherence check.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Oslo、挪威、0407
- Oslo University Hospital
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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:
- 18 years and above
- Residing in Oslo/Akershus
- Ambulatory Systolic Daytime Blood Pressure ≥ 135 mmHg
- ≥ 2 antihypertensive medications
- Be able to read and write Norwegian
Exclusion Criteria:
- Critical illness, ongoing treatment
- Known atrial fibrillation
- Known heart valve stenosis
- Myocardial infarction, angina pectoris or stroke the past 6 months
- Known severe renal impairment (eGFR < 30 ml/min/1.73 m2)
- History of DOT prior to ABPM
- Participation in other interventional study
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预：控制
标准护理
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实验性的：Direct Observed Therapy
Direct Observed Therapy immediately followed by mounting of ambulatory blood pressure device and measurement of ambulatory blood pressure according to ESH 2013 guidelines.
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Patients allocated to the intervention group take their medication (from original blister packaged) in front of the invistigator who observe the patient swallowing the medication.
To secure the principals of Direct Observed Therapy, the patient do not leave the clinic for two hours.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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Change in 24-hour ambulatory mean systolic daytime blood pressure
大体时间：Measurement at follow-up visit 3 weeks ± 7 days relative to baseline.
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Measurement at follow-up visit 3 weeks ± 7 days relative to baseline.
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次要结果测量
结果测量 |
大体时间 |
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Change in mean office systolic blood pressure
大体时间：Measurement at follow-up visit 3 weeks ± 7 days relative to baseline.
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Measurement at follow-up visit 3 weeks ± 7 days relative to baseline.
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合作者和调查者
调查人员
- 首席研究员：Aud Høieggen, MD PhD、Oslo University Hospital
出版物和有用的链接
一般刊物
- Fadl Elmula FE, Hoffmann P, Fossum E, Brekke M, Gjonnaess E, Hjornholm U, Kjaer VN, Rostrup M, Kjeldsen SE, Os I, Stenehjem AE, Hoieggen A. Renal sympathetic denervation in patients with treatment-resistant hypertension after witnessed intake of medication before qualifying ambulatory blood pressure. Hypertension. 2013 Sep;62(3):526-32. doi: 10.1161/HYPERTENSIONAHA.113.01452. Epub 2013 Jul 8.
- Fadl Elmula FE, Hoffmann P, Larstorp AC, Fossum E, Brekke M, Kjeldsen SE, Gjonnaess E, Hjornholm U, Kjaer VN, Rostrup M, Os I, Stenehjem A, Hoieggen A. Adjusted drug treatment is superior to renal sympathetic denervation in patients with true treatment-resistant hypertension. Hypertension. 2014 May;63(5):991-9. doi: 10.1161/HYPERTENSIONAHA.114.03246. Epub 2014 Mar 3.
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 (实际的)
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.
Direct Observed Therapy的临床试验
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Institute of Cancer Research, United KingdomCancer Research UK; University of Manchester; University of Sussex完全的
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University of Applied Sciences and Arts of Southern...Vrije Universiteit Brussel; Universiteit Antwerpen; THIM - die internationale Hochschule für Physiotherapie完全的