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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01567189
Recruitment Status : Unknown
Verified March 2012 by Fernando Arós Borau, Basque Health Service.
Recruitment status was:  Not yet recruiting
First Posted : March 30, 2012
Last Update Posted : March 30, 2012
Information provided by (Responsible Party):
Fernando Arós Borau, Basque Health Service

February 22, 2012
March 30, 2012
March 30, 2012
April 2012
April 2013   (Final data collection date for primary outcome measure)
  • Morbidity [ Time Frame: 1 year ]
    Readmissions, percutaneous or surgical revascularization
  • Cost [ Time Frame: 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).
Same as current
No Changes Posted
  • Control of risk factors [ Time Frame: 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 [ Time Frame: 1 year ]
    Oxygen consumption peak measured during exercise testing
  • Quality of Life [ Time Frame: 1 year ]
    SF-12 version 2
  • Satisfaction [ Time Frame: 1 year ]
    satisfaction questionnaire based on Osakidetza Basque Health Service questionnaires
  • Mortality [ Time Frame: 1 year ]
    All cause mortality
Same as current
Not Provided
Not Provided
Cost-effectiveness of Outpatient Versus Hospital Cardiac Rehabilitation
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

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.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Coronary Heart Disease
  • 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.
  • Experimental: Hospital cardiac rehabilitation
    The patients will perform physical training sessions in the hospital
    Intervention: Behavioral: Cardiac rehabilitation
  • Active Comparator: Home cardiac rehabilitation
    The patients will perform physical training sessions at home
    Intervention: Behavioral: Cardiac rehabilitation
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
April 2013
April 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Fernando Arós Borau, Basque Health Service
Basque Health Service
Not Provided
Not Provided
Basque Health Service
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP