HOme telemonitoRing of Arterial hypertensiOn With antihypertenSive Treatment Titration: a Randomized COntrolled prosPEctive Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 460
- 试验地点
- 1
- 主要终点
- Mean of 24h systolic blood pressure (SBP)
研究概览
简要总结
Rater blinded, multi-center, prospective, randomized controlled study comparing mean 24 hour systolic blood pressure of eligible hypertensive patients in the TELEMONITORIN group versus the USUAL CARE group, at 6 months after inclusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Included are patients with:
- •age ≥ 35 years old
- •newly diagnosed hypertention
- •uncontrolled hypertention
排除标准
- •Excluded are patients with:
- •orthostatic hypotension
- •chronic renal failure (serum creatinine > 200 micromol / L)
- •acute coronary syndrome
- •coronary revascularization or stroke within the past 3 months
- •known secondary causes of hypertension
- •pregnancy
- •New York Heart Association Class III or IV heart failure or left ventricular ejection fraction < 30%
- •dementia or another cause that prevents the application of remote monitoring
研究组 & 干预措施
Telemonitoring
In addition to the usual care, this group benefits from a weekly telephone call by the Clinical Research Associate (CRA) for the collection of home blood pressure measurements (which the patient measures twice a day everyday), for therapeutic education, and for treatment compliance assessment.
This group will also benefit from a monthly call by the attending physician for treatment titration and side effects check.
干预措施: Telemonitoring (Procedure)
Conventional
This group will benefit form the usual care without any phone calls for therapeutic education, treatment compliance assessment, treatment titration or side effects check.
The usual care includes attending the follow up visits after inclusion at Day 90 (D-90) & Day 180 (D-180) for face to face consultation with the attending physician.
干预措施: Usual Care without Telemonitoring (Procedure)
结局指标
主要结局
Mean of 24h systolic blood pressure (SBP)
时间窗: 0 - 180 days
The change from baseline of mean 24-hour systolic blood pressure (SBP) at 6 months of follow-up
次要结局
- percentage of Dipping(0-180 days)
- frequency of cardiovascular complications(180 days)
- Mean of the Short Form survey (SF-12) scores(0-180 days)
- Mean of 24h diastolic blood pressure (DBP)(0-180 days)
- percentage of blood pressure load(0-180 days)