Cost-effectiveness of Outpatient Versus Hospital Cardiac Rehabilitation (CERC1)

Basque Health Service

Status: Unknown

Conditions: Coronary Heart Disease

Treatments: Behavioral: Cardiac rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT01567189

CERC1

Details and patient eligibility

About

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

1. direct and indirect healthcare costs
2. effectiveness on mortality, morbidity, modifiable risk factors control, functional capacity measured by exercise testing, health related quality of life and satisfaction rate
3. cost/effectiveness analysis

Full 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.

Enrollment: 138 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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138 participants in 2 patient groups

Hospital cardiac rehabilitation

Experimental group

Description:

The patients will perform physical training sessions in the hospital

Treatment:

Behavioral: Cardiac rehabilitation

Behavioral: Cardiac rehabilitation

Home cardiac rehabilitation

Active Comparator group

Description:

The patients will perform physical training sessions at home

Treatment:

Behavioral: Cardiac rehabilitation

Behavioral: Cardiac rehabilitation