Outpatient Cardiac Rehabilitation Versus Hospital. Cost-effectiveness Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 138
- 试验地点
- 2
- 主要终点
- Morbidity
研究概览
简要总结
The hypothesis is that home based clinical rehabilitation (CR) is less expensive than hospital based CR with similar clinical effectiveness. The investigators will compare the results of two forms of CR on
- direct and indirect healthcare costs
- effectiveness on mortality, morbidity, modifiable risk factors control, functional capacity measured by exercise testing, health related quality of life and satisfaction rate
- cost/effectiveness analysis
详细描述
The main reasons for patients not to participate in a cardiac rehabilitation program that usually develops by group in the hospital or in a gym, are problems of access to hospital, disgust for participating in a group activity and problems in reconciling their work and / or home with the program schedule. These problems could be overcome by outcome cardiac rehabilitation and thus could increase the number of patients benefit from treatment in either the environment extra or intra-hospital.
Low and medium coronary patients sent to cardiac rehabilitation program at our center within the first 12 weeks after presenting with acute coronary syndrome or been revascularized will be included in the study. The prescription of intensity of effort is based on heart rate reached during the stress test for the initial evaluation in all cases, although at home-program heart rate will be monitored using heart rate monitor and / or by the Borg scale. In this way outpatient group patient could performed training sessions individually and at the time of day that best suits their capabilities. The other program components: control of risk factors, health education and counseling will be identical in both groups of patients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients referred to cardiac rehabilitation program in the first twelve weeks after an acute coronary syndrome (myocardial infarction or unstable angina) or after percutaneous or surgical revascularization
- •who have no contraindication to participate in the program
排除标准
- •contraindication to participate in the program
- •high-risk criteria for home cardiac rehabilitation.
研究组 & 干预措施
Hospital cardiac rehabilitation
The patients will perform physical training sessions in the hospital
干预措施: Cardiac rehabilitation (Behavioral)
Home cardiac rehabilitation
The patients will perform physical training sessions at home
干预措施: Cardiac rehabilitation (Behavioral)
结局指标
主要结局
Morbidity
时间窗: 1 year
Readmissions, percutaneous or surgical revascularization
Cost
时间窗: 1 year
1. Direct costs 1. direct healthcare costs: hospital admissions for cardiovascular causes, percutaneous or surgical revascularization, medical and nursing consultation, physical training sessions, medical explorations including the analytic explorations, medication consumption, emergency department visits, depreciation of equipment used. 2. Direct costs other than health: Transfer the patient for his attention, passenger costs if necessary. 2. Indirect costs: working days lost during program participation (2 months, family overloads caused by participation in the program (2 months).
次要结局
- Satisfaction(1 year)
- Mortality(1 year)
- Quality of Life(1 year)
- Control of risk factors(1 year)
- Functional capacity(1 year)
研究者
Fernando Arós Borau
Cardiologist
Basque Health Service