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

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

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Behavioral: Cardiac rehabilitation Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Outpatient Cardiac Rehabilitation Versus Hospital. Cost-effectiveness Study
Study Start Date : April 2012
Estimated Primary Completion Date : April 2013
Estimated Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

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.

Active Comparator: Home cardiac rehabilitation
The patients will perform physical training sessions at home
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.

Primary Outcome Measures :
  1. Morbidity [ Time Frame: 1 year ]
    Readmissions, percutaneous or surgical revascularization

  2. 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).

Secondary Outcome Measures :
  1. 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

  2. Functional capacity [ Time Frame: 1 year ]
    Oxygen consumption peak measured during exercise testing

  3. Quality of Life [ Time Frame: 1 year ]
    SF-12 version 2

  4. Satisfaction [ Time Frame: 1 year ]
    satisfaction questionnaire based on Osakidetza Basque Health Service questionnaires

  5. Mortality [ Time Frame: 1 year ]
    All cause mortality

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01567189

Contact: Fernando Aros Borau +34 945 007000

Araba University Hospital Not yet recruiting
Vitoria, Álava, Spain, 01009
Sponsors and Collaborators
Basque Health Service

Responsible Party: Fernando Arós Borau, Cardiologist, Basque Health Service Identifier: NCT01567189     History of Changes
Other Study ID Numbers: CERC1
First Posted: March 30, 2012    Key Record Dates
Last Update Posted: March 30, 2012
Last Verified: March 2012

Keywords provided by Fernando Arós Borau, Basque Health Service:
Exercise therapy
cost effectiveness
cardiac rehabilitation
home-based exercise

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases