Cost-effectiveness of Outpatient Versus Hospital Cardiac Rehabilitation

Not Applicable

• Conditions: Coronary Heart Disease
• Interventions: Behavioral: Cardiac rehabilitation

• Registration Number: NCT01567189
• Lead Sponsor: Basque Health Service

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.

Study Timeline

• Study First Submitted: 2012-02-22
• Status Verified: 2012-03
• Study First Submitted QC: 2012-03-28
• Last Update Submitted: 2012-03-28
• Study First Posted: 2012-03-30
• Last Update Posted: 2012-03-30
• Study Start: 2012-04
• Primary Completion: 2013-04
• Study Completion: 2013-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 138

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hospital cardiac rehabilitation	Cardiac rehabilitation	The patients will perform physical training sessions in the hospital
Home cardiac rehabilitation	Cardiac rehabilitation	The patients will perform physical training sessions at home

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Satisfaction	1 year	satisfaction questionnaire based on Osakidetza Basque Health Service questionnaires
Mortality	1 year	All cause mortality
Quality of Life	1 year	SF-12 version 2
Control of risk factors	1 year	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
Functional capacity	1 year	Oxygen consumption peak measured during exercise testing

Trial Locations

Locations (1)

Araba University Hospital; 🇪🇸 Vitoria, Álava, Spain