Cost-effectiveness of Outpatient Versus Hospital Cardiac Rehabilitation

Coronary Heart Disease Clinical Trial

— CERC1  

Official title:

Outpatient Cardiac Rehabilitation Versus Hospital. Cost-effectiveness Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01567189
• Other study ID #: CERC1
• Status: Not yet recruiting
• Phase: N/A
• First received: February 22, 2012
• Last updated: March 28, 2012
• Start date: April 2012
• Est. completion date: April 2013

Study information

• Verified date: March 2012
• Source: Basque Health Service
• Contact: Fernando Aros Borau
• Phone: +34 945 007000
• Email: LUISFDO.AROSBORAU[@]osakidetza.net
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 138
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Myocardial Ischemia

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Spain	Araba University Hospital	Vitoria	Álava

Sponsors (1)

Lead Sponsor	Collaborator
Basque Health Service

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morbidity	Readmissions, percutaneous or surgical revascularization	1 year	No
Primary	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	No
Secondary	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	No
Secondary	Functional capacity	Oxygen consumption peak measured during exercise testing	1 year	No
Secondary	Quality of Life	SF-12 version 2	1 year	No
Secondary	Satisfaction	satisfaction questionnaire based on Osakidetza Basque Health Service questionnaires	1 year	No
Secondary	Mortality	All cause mortality	1 year	No