A Remote Nursing-Guided Secondary Prevention Programme in Acute Coronary Syndrome. The SPRING Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 484
- 试验地点
- 4
- 主要终点
- major adverse events
研究概览
简要总结
DESIGN: Controlled clinical trial with single randomization, unmasked, open and multicentric.
CENTERS: University Hospital of A Coruña and University Hospital of Ferrol CONDITION TO STUDY: Acute Coronary Syndrome (ACS). INTERVENTION:monitored outhospital not inhospital supervised. MAIN OBJECTIVE: To determine the incidence of major adverse events (total mortality, new ACS, coronary revascularization, all-cause hospitalization) during the one-year period after hospitalization for ACS.
详细描述
The SPRING study aims to learn whether a remote, nurse-guided secondary prevention program reduces adverse events in patients who suffer an infarction during the subsequent one-year period. The SPRING study focuses not only on adverse events but also on the patients' state of life in terms of diet, physical exercise, emotional state, tobacco use, and adherence to medical treatment. Nursing is a profession in charge of preserving the health of patients, which is why the remote secondary cardiovascular prevention program of this study is coordinated by a nurse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients who have suffered an ACS in the health area of A Coruña or Ferrol from the beginning of the study inclusion period until reaching the fixed sample size.
- •Ages between 18 and 75 years.
- •Patients with ability to read and understand the participation sheet in the study.
- •Patients signing informed consent to participate in the study.
- •Patients living in the health care area of HUAC or HUF.
排除标准
- •Patients who are dependent for the Basic Activities of Daily Living (BADL) or who suffer from severe cognitive impairment (which makes reliable anamnesis impossible).
- •Patients with a Left Ventricular Ejection Fraction (LVEF) less than or equal to 35%.
- •Patients with a NYHA III / IV score and / or the Canadian Cardiovascular Association (CCS) scale of IV.
结局指标
主要结局
major adverse events
时间窗: 1 year
total mortality, new ACS, coronary revascularization, hospitalization for any cause
次要结局
- cardiovascular mortality(1 year)
- cardiovascular hospitalization(one year)
- stroke(1 year)
- tobacco(1 year)
- physical activity(1 year)
- nutrition(1 year)
- emotion state(1 year)
研究者
CARMEN NERI FERNANDEZ POMBO
Research Nurse.
University Hospital A Coruña