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

Outpatient Cardiac Rehabilitation Versus Hospital. Cost-effectiveness Study

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

Study Overview

• Status: Unknown
• Conditions: Coronary Heart Disease
• Intervention / Treatment: Behavioral: Cardiac rehabilitation; Behavioral: Cardiac rehabilitation

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 Type: Interventional
• Enrollment (Anticipated): 138
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fernando Aros Borau; Phone Number: +34 945 007000; Email: LUISFDO.AROSBORAU@osakidetza.net

Study Locations

• Spain
  • Álava
    • Vitoria, Álava, Spain, 01009
      • Araba University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hospital cardiac rehabilitation; The patients will perform physical training sessions in the hospital	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.; 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.
Active Comparator: Home cardiac rehabilitation; The patients will perform physical training sessions at home	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity	Readmissions, percutaneous or surgical revascularization	1 year
Cost	Direct costsdirect 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Functional capacity	Oxygen consumption peak measured during exercise testing	1 year
Quality of Life	SF-12 version 2	1 year
Satisfaction	satisfaction questionnaire based on Osakidetza Basque Health Service questionnaires	1 year
Mortality	All cause mortality	1 year

Collaborators and Investigators

• Sponsor: Basque Health Service

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Anticipated): April 1, 2013
• Study Completion (Anticipated): April 1, 2013

Study Registration Dates

• First Submitted: February 22, 2012
• First Submitted That Met QC Criteria: March 28, 2012
• First Posted (Estimate): March 30, 2012

Study Record Updates

• Last Update Posted (Estimate): March 30, 2012
• Last Update Submitted That Met QC Criteria: March 28, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: cost effectiveness; Exercise therapy; cardiac rehabilitation; home-based exercise
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: CERC1