search
Back to results

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

Primary Purpose

Coronary Heart Disease

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Cardiac rehabilitation
Cardiac rehabilitation
Sponsored by
Basque Health Service
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Heart Disease focused on measuring Exercise therapy, cost effectiveness, cardiac rehabilitation, home-based exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Araba University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hospital cardiac rehabilitation

Home cardiac rehabilitation

Arm Description

The patients will perform physical training sessions in the hospital

The patients will perform physical training sessions at home

Outcomes

Primary Outcome Measures

Morbidity
Readmissions, percutaneous or surgical revascularization
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).

Secondary Outcome Measures

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

Full Information

First Posted
February 22, 2012
Last Updated
March 28, 2012
Sponsor
Basque Health Service
search

1. Study Identification

Unique Protocol Identification Number
NCT01567189
Brief Title
Cost-effectiveness of Outpatient Versus Hospital Cardiac Rehabilitation
Acronym
CERC1
Official Title
Outpatient Cardiac Rehabilitation Versus Hospital. Cost-effectiveness Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
April 2013 (Anticipated)
Study Completion Date
April 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Basque Health Service

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 direct and indirect healthcare costs effectiveness on mortality, morbidity, modifiable risk factors control, functional capacity measured by exercise testing, health related quality of life and satisfaction rate 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
Keywords
Exercise therapy, cost effectiveness, cardiac rehabilitation, home-based exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hospital cardiac rehabilitation
Arm Type
Experimental
Arm Description
The patients will perform physical training sessions in the hospital
Arm Title
Home cardiac rehabilitation
Arm Type
Active Comparator
Arm Description
The patients will perform physical training sessions at home
Intervention Type
Behavioral
Intervention Name(s)
Cardiac rehabilitation
Intervention Description
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
Intervention Name(s)
Cardiac rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Morbidity
Description
Readmissions, percutaneous or surgical revascularization
Time Frame
1 year
Title
Cost
Description
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).
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Control of risk factors
Description
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
Time Frame
1 year
Title
Functional capacity
Description
Oxygen consumption peak measured during exercise testing
Time Frame
1 year
Title
Quality of Life
Description
SF-12 version 2
Time Frame
1 year
Title
Satisfaction
Description
satisfaction questionnaire based on Osakidetza Basque Health Service questionnaires
Time Frame
1 year
Title
Mortality
Description
All cause mortality
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fernando Aros Borau
Phone
+34 945 007000
Email
LUISFDO.AROSBORAU@osakidetza.net
Facility Information:
Facility Name
Araba University Hospital
City
Vitoria
State/Province
Álava
ZIP/Postal Code
01009
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Cost-effectiveness of Outpatient Versus Hospital Cardiac Rehabilitation

We'll reach out to this number within 24 hrs