Default BP Medication Intensification
2017年1月30日 更新者:Florian Rader, MD, MSc、Cedars-Sinai Medical Center
Automatic Medication Increase Protocol in the Treatment of Elevated Blood Pressure
High blood pressure leads to heart attacks and strokes which can be prevented by blood pressure-lowering medication.
However, the current office-based prescription of one pill and one dose at a time is ineffective.
the investigators want to pilot-test a more effective patient-centered treatment approach, where patients will receive a prescription with gradual but automatic weekly increases of dose and number of pills.
Patients will measure their blood pressure with an iPhone compatible cuff, which transmits readings to the doctor or pharmacist, who will stop escalation when the desired blood pressure level is reached.
The investigators hypothesize that the intervention will decrease the time to control blood pressure and increase the overall rate of blood pressure control.
Therefore, this new treatment model could prevent heart attacks and strokes, and reduce healthcare costs.
研究概览
详细说明
This is a pilot 2A trial of an innovative behavioral economics theory-based antidote for physician inertia in the medical treatment of hypertension (HTN).
In the current reactive physician-centered model, blood pressure (BP) is measured and medical decisions are made in the physician office; when deciding whether or not to prescribe new medication for a high office BP reading, the physician's default behavior is inaction.
The investigators propose default medication intensification as a new patient-centered/pharmacist-assisted proactive treatment model to eliminate physician inertia.
For enrolled patients with office BP>155/95, the physician will prescribe a one-month protocol that automatically escalates drug dose and drug number each week.
The pharmacist will fill the prescription in a blister pack to simplify adherence.
The patient will measure daily home BP with an iPhone cuff that transmits the data electronically to the pharmacist, who will halt the protocol if goal home BP<135/85 is achieved ahead of schedule.
the investigators will pilot test the feasibility and safety of self-monitoring plus the new automatic intensification protocol packaged in blisters.
Default medication intensification could revolutionize HTN treatment and reduce healthcare costs.
研究类型
介入性
注册 (实际的)
3
阶段
- 阶段2
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
California
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Los Angeles、California、美国、90048
- Cedars-Sinai Medical Center
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 55年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 18 to 55 years old
- office BP of ≥160 mmHg systolic and ≥100 mmHg diastolic (treated or untreated) AND <180 mmHg systolic.
Exclusion Criteria:
- chronic kidney disease
- symptomatic coronary artery disease
- congestive heart failure
- more than mild valvular heart disease
- Diabetes mellitus
- obstructive left ventricular hypertrophy
- severe electrolyte abnormalities
- multiple medication intolerances
- orthostatic hypotension
- cognitive impairment and mental disorders affecting ability to self-monitor BP
- patients who are unwilling to measure and transmit BP readings throughout the study
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:default intensification arm (all)
all subjects will receive blister packs with weekly increasing blood pressure medications.
There is no control arm for this study
|
The investigators will determine which blood pressure medications to use.
No specific drug will be tested but rather the automatic intensification of medications is the intervention.
Examples of drugs used in this study are calcium channel blockers (e.g., amlodipine 2.5 mg to 10 mg) or ACE-inhibitors (e.g., lisinopril 5 mg to 40 mg) or diuretics (HCTZ 25 mg).
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 |
措施说明 |
大体时间 |
|---|---|---|
|
Symptomatic hypotension
大体时间:from enrollment to 12 weeks
|
Primary safety outcome is symptomatic hypotension during study participation (12 weeks).
Safety monitoring will be achieved with patient-directed iPhone-based BP measuring and transmitting to study staff.
|
from enrollment to 12 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
hypertension control rate
大体时间:at 12 weeks
|
The investigators will assess blood pressure throughout the study period (12 weeks) with iPhone based technology.
Hypertension control is defined as home blood pressure <135/85 mmHg
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at 12 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Phillips LS, Branch WT, Cook CB, Doyle JP, El-Kebbi IM, Gallina DL, Miller CD, Ziemer DC, Barnes CS. Clinical inertia. Ann Intern Med. 2001 Nov 6;135(9):825-34. doi: 10.7326/0003-4819-135-9-200111060-00012.
- O'Connor PJ. Overcome clinical inertia to control systolic blood pressure. Arch Intern Med. 2003 Dec 8-22;163(22):2677-8. doi: 10.1001/archinte.163.22.2677. No abstract available.
- Green BB, Cook AJ, Ralston JD, Fishman PA, Catz SL, Carlson J, Carrell D, Tyll L, Larson EB, Thompson RS. Effectiveness of home blood pressure monitoring, Web communication, and pharmacist care on hypertension control: a randomized controlled trial. JAMA. 2008 Jun 25;299(24):2857-67. doi: 10.1001/jama.299.24.2857. Erratum In: JAMA. 2009 Nov 11;302(18):1972.
- Bray EP, Holder R, Mant J, McManus RJ. Does self-monitoring reduce blood pressure? Meta-analysis with meta-regression of randomized controlled trials. Ann Med. 2010 Jul;42(5):371-86. doi: 10.3109/07853890.2010.489567.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年11月1日
初级完成 (实际的)
2015年9月1日
研究完成 (实际的)
2015年12月1日
研究注册日期
首次提交
2013年11月12日
首先提交符合 QC 标准的
2013年11月22日
首次发布 (估计)
2013年11月25日
研究记录更新
最后更新发布 (估计)
2017年2月1日
上次提交的符合 QC 标准的更新
2017年1月30日
最后验证
2017年1月1日
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.