Cost-effectiveness of Outpatient Versus Hospital Cardiac Rehabilitation

Study Overview
=================
Brief Summary
-----------------
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

Detailed Description
-----------------
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.

Official Title
-----------------
Outpatient Cardiac Rehabilitation Versus Hospital. Cost-effectiveness Study

Conditions
-----------------
Coronary Heart Disease

Intervention / Treatment
-----------------
* Behavioral: Cardiac rehabilitation
* Behavioral: Cardiac rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: contraindication to participate in the program high-risk criteria for home cardiac rehabilitation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hospital cardiac rehabilitation<br>The patients will perform physical training sessions in the hospital | Behavioral: Cardiac rehabilitation<br>* Training sessions: 8 weeks of supervised physical training sessions. Stress intensity will be calculated from the peak heart rate reached during stress test: 60-70% during the first month and 70-85% during the second one. Patients will be advised to do at least 1 hour of outdoor exercise with the same intensity on the days when they do not attend hospital. Health education sessions and relaxation sessions: one per week. Smoking and diet checking: as recommended by doctor.<br>|
| Active Comparator: Home cardiac rehabilitation<br>The patients will perform physical training sessions at home | Behavioral: Cardiac rehabilitation<br>* The only difference in the hospital's program is that training sessions will be out of hospital with the same target heart rate that in this case will be controlled with pulsometer or Borg scale. The recommended frequency of sessions will be: at least 5 days a week with a minimum of 1 hour / day.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity | Readmissions, percutaneous or surgical revascularization | 1 year | 
| Cost | Direct costs 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. Direct costs other than health: Transfer the patient for his attention, passenger costs if necessary. Indirect costs: working days lost during program participation (2 months, family overloads caused by participation in the program (2 months). | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Control of risk factors | Control of risk factors at the end of training sessions and one year after the acute event: Percentage of patients achieving the therapeutic goal outlined in the clinical practice guidelines in each of the risk factors | 1 year | 
| Functional capacity | Oxygen consumption peak measured during exercise testing | 1 year | 
| Quality of Life | SF-12 version 2 | 1 year | 
| Satisfaction | satisfaction questionnaire based on Osakidetza Basque Health Service questionnaires | 1 year | 
| Mortality | All cause mortality | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise therapy, cost effectiveness, cardiac rehabilitation, home-based exercise