Cost-effectiveness of Outpatient Versus Hospital Cardiac Rehabilitation

NCT ID: NCT01567189

Last Updated: 2012-03-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-04-30

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.

Conditions

Coronary Heart Disease

Keywords

Exercise therapy; cost effectiveness; cardiac rehabilitation; home-based exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hospital cardiac rehabilitation

The patients will perform physical training sessions in the hospital

Group Type: EXPERIMENTAL

Cardiac rehabilitation

Intervention Type: BEHAVIORAL

• 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.

Home cardiac rehabilitation

The patients will perform physical training sessions at home

Group Type: ACTIVE_COMPARATOR

Cardiac rehabilitation

Intervention Type: BEHAVIORAL

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.

Interventions

Cardiac rehabilitation

• 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.

Intervention Type: BEHAVIORAL

Cardiac rehabilitation

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Basque Health Service

OTHER_GOV

Sponsor Role: lead

Responsible Party

Fernando Arós Borau

Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Araba University Hospital

Vitoria-Gasteiz, Álava, Spain

Countries

Spain

Central Contacts

Fernando Aros Borau

Role: CONTACT

Phone: +34 945 007000

Email: LUISFDO.AROSBORAU@osakidetza.net

Other Identifiers

CERC1

Identifier Type: -

Identifier Source: org_study_id