NCT02730052撤回不适用
Estudio RioplateNsE Sobre Telemonitoreo en hIpertensos No-controlAdos
Universidad de la Republica12 个研究点 分布在 2 个国家开始时间: 2016年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 12
- 主要终点
- Time to blood pressure control
研究概览
简要总结
The proportion of hypertensive patients achieving adequate blood pressure control meeting guideline targets remains low. Of those patients on blood pressure lowering drugs, only 50% reach control.
Objectives:
- Test the feasibility of telemonitoring of blood pressure in uncontrolled hypertensive patients.
- Investigate whether telemonitoring enabled self-measurement of blood pressure leads to faster blood pressure control than self-measurement without telemonitoring.
- Secondary endpoints include adverse effects, assessment of quality of life, adherence, a log of technical problems, and cost-effectiveness.
Methods:
Randomised parallel-group study consisting of 4 stages.
- Screening to check for eligibility.
- Randomisation in a 1:1 proportion to control or experimental arm: In the control arm, doctors will receive reports on the self-measured blood pressure based on diary cards; in the experimental group, doctors will receive weekly reports via telemonitoring.
- Treatment period: Doctors will adjust treatment according to the present guidelines of Hypertension. Blood pressure control is a home blood pressure below 135 mm Hg systolic and 85 mm Hg diastolic. Once blood pressure control is achieved the treatment period ends.
- Late follow-up: Assessment of blood pressure control at home 3 months after completion of the treatment period by means of telemonitoring.
Sample size: 120 patients per group. Patients: recruited at clinics from Uruguay and Argentina.
Main Inclusion Criteria:
- Women and men, age range 20 to 80 years.
- Uncontrolled hypertension and new diagnosed hypertension with a self-measured blood pressure at home of 135 mm Hg systolic and/or 85 mm Hg diastolic or more;
- Patients should be willing to accept adherence checking during follow-up and sign an informed written consent.
Exclusion Criteria
- Patients emotionally or intellectually not capable of measuring their blood pressure at home;
- A clinical or social context, which is suboptimal for the self-measurement of blood pressure;
- Pregnancy;
- Alcohol or substance abuse or psychiatric illnesses;
- Participation in another study. Expected outcomes: blood pressure control will be achieved faster in the telemonitoring group.
详细描述
- Research Questions
Previous studies demonstrated the feasibility of telemonitoring of blood pressure. However, several issues remain unaddressed.
- Feasibility of telemonitoring within the South American context has never been tested. No attempt has ever been made in South America to assess adherence to antihypertensive drugs in primary care.
- Telemonitoring of blood pressure will never make it to the routine clinical practice unless it can be proven that application of the technique results in faster and better blood pressure control compared with usual care including self-measurement of blood pressure at home.
- Secondary endpoints must also include adverse events, a simple assessment of quality of life, adherence, a log of technical problems, and cost-effectiveness.
- General Design
ERNESTINA is a randomised parallel-group study, which will address the feasibility and potential benefits of telemonitoring of blood pressure at home. Eligible patients will be recruited at outpatient medical clinics.
- Screening period followed by stratification and randomisation: Screening involves checking inclusion and exclusion criteria, ruling out secondary hypertension remediable by specific treatment, and obtaining informed written consent as outlined in the Helsinki declaration.
Eligible patients will be stratified by centre and randomised in a one-to-one proportion to control or intervention. Randomisation will be implemented by sequentially numbered sealed envelopes, which contain the group assignment. These envelopes will be available at the practices, so that no contact with the Studies Coordinating Centre (SCC) will be necessary to randomise the patient.
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
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women and men are eligible. Women of reproductive age should apply effective contraception.
- •Age ranges from 20 years (inclusive) to 80 years.
- •At screening, patients should have hypertension, which is uncontrolled on medical treatment. Uncontrolled hypertension is an office blood pressure of 140 mm Hg systolic or 90 mm Hg diastolic or higher AND a self-measured blood pressure at home of 135 mm Hg systolic or 85 mm Hg diastolic or more. Practitioners will receive a weekly report on the self-measured blood pressure at home summarising the results of the run-in period.
- •At the screening visit, patients should either be untreated for at least 4 weeks or taking a stable drug regimen for at least 4 weeks. Medical treatment can consist of all major drug classes. This includes diuretics, beta-blockers, alfa-blockers, calcium-channel blockers (CCBs), inhibitors of the renin system (angiotensin-converting enzyme inhibitors (ACEIs), angiotensin II type 1 receptor blockers (ARBs), the direct renin inhibitor aliskiren,18 aldosterone receptor antagonists (ARAs), centrally acting antihypertensive drugs and vasodilators (hydralazine). In line with current recommendations and recent studies, unless contra-indicated or not tolerated, aldosterone antagonists, such as spironolactone 25 to 50 mg per day should have been attempted for at least 4 weeks to improve blood pressure control in treatment-resistant patients. (1) The patients should be intellectually and emotionally capable of measuring their blood pressure at home and accept to keep a diary (control group) or to have a report sent to their doctor (intervention group).
- •Patient should provide written informed consent.
排除标准
- •The clinical context is suboptimal for telemonitoring of blood pressure:
- •Myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months of the screening period;
- •Type 1 diabetes mellitus requiring multiple adjustments of treatment to maintain control or diabetes mellitus with recent hyperglycaemic or hypoglycaemic coma;
- •Renal dysfunction defined as an estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73m2, using the Modification of Diet in Renal Disease formula;
- •Secondary hypertension, in which treatment options other than antihypertensive drug treatment are indicated;
- •Sleep apnea syndrome that qualifies for treatment with continuous positive airway pressure (CPAP);
- •Atrial fibrillation or arrhythmia making oscillometric blood pressure measurement unreliable;
- •The patient is on a waiting list for elective surgery or a cardiovascular intervention;
- •Patients with alcohol or substance abuse or psychiatric illnesses.
- •The patients should not have any serious medical condition, which in the opinion of the investigator, may adversely interfere with self-measurement of blood pressure at home.
- •Patients should not participate in any other trial of an investigational drug or device.
研究组 & 干预措施
Omron 9200T without Telemonitoring
Active Comparator
In the control group doctors will receive information on the self-measured blood pressure as recorded at home via a diary card.
干预措施: Omron 9200T without Telemonitoring (Device)
Omron 9200T plus Telemonitoring
Experimental
In the intervention group, doctors will receive weekly reports via telemonitoring of self-measured blood pressure.
干预措施: Omron 9200T plus Telemonitoring (Device)
结局指标
主要结局
Time to blood pressure control
时间窗: through study completion, an average of 2 years
Blood pressure control will be defined as a self-measured blood pressure at home below 135 mm Hg systolic and 85 mm Hg diastolic. Blood pressure control is assumed to be present if the aforementioned levels are attained during the preceding week to medical control.
次要结局
- Adverse events, recorded by a self-administered questionnaire(through study completion, an average of 2 years)
- Assessment of drug adherence using Morisky questionnaire(through study completion, an average of 2 years)
- The proportion of patients reaching and maintaining blood pressure control on self-measurement and office measurement at the late follow-up visit(through study completion, an average of 2 years)
- Total pill load per day(through study completion, an average of 2 years)
- Assessment of quality of life using the Euro-Quality-of-life questionnaire "EQ-5D-5L"(through study completion, an average of 2 years)
- The proportion of patients reaching blood pressure control on self-measurement at home and office measurement(through study completion, an average of 2 years)
- Number of single-pill combinations(through study completion, an average of 2 years)
- Health care costs from randomization to last follow-up(through study completion, an average of 2 years)
研究者
José Boggia
MD PhD
Universidad de la Republica
研究点 (12)
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