Clinical trial NCT01567189: Cost-effectiveness of Outpatient Versus Hospital Cardiac Rehabilitation
Official title: Outpatient Cardiac Rehabilitation Versus Hospital. Cost-effectiveness Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Heart Disease
Keywords: Exercise therapy
cost effectiveness
cardiac rehabilitation
home-based exercise
Lead sponsor: Basque Health Service
Sponsor class: OTHER_GOV
First posted: 2012-03-30
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

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.

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.

Primary outcomes:
measure: Morbidity
timeFrame: 1 year
measure: Cost
timeFrame: 1 year
Secondary outcomes:
measure: Control of risk factors
timeFrame: 1 year
measure: Functional capacity
timeFrame: 1 year
measure: Quality of Life
timeFrame: 1 year
measure: Satisfaction
timeFrame: 1 year
measure: Mortality
timeFrame: 1 year
Other outcomes:
Locations:
city: Vitoria
country: Spain
facility: Araba University Hospital
state: Álava
Study officials:
References: