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

This study is not yet open for participant recruitment.
Verified March 2012 by Basque Health Service
Sponsor:
Information provided by (Responsible Party):
Fernando Arós Borau, Basque Health Service
ClinicalTrials.gov Identifier:
NCT01567189
First received: February 22, 2012
Last updated: March 28, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention
Coronary Heart Disease
 Behavioral: Cardiac rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Outpatient Cardiac Rehabilitation Versus Hospital. Cost-effectiveness Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Basque Health Service:

Primary Outcome Measures:
  • Morbidity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Readmissions, percutaneous or surgical revascularization

  • Cost [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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:
  • Control of risk factors [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Oxygen consumption peak measured during exercise testing

  • Quality of Life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    SF-12 version 2

  • Satisfaction [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    satisfaction questionnaire based on Osakidetza Basque Health Service questionnaires

  • Mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    All cause mortality


Estimated Enrollment: 138
Study Start Date: April 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01567189

Contacts
Contact: Fernando Aros Borau +34 945 007000 LUISFDO.AROSBORAU@osakidetza.net

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

No publications provided

Responsible Party: Fernando Arós Borau, Cardiologist, Basque Health Service
ClinicalTrials.gov Identifier: NCT01567189     History of Changes
Other Study ID Numbers: CERC1
Study First Received: February 22, 2012
Last Updated: March 28, 2012
Health Authority: Spain: Ethics Committee

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

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

ClinicalTrials.gov processed this record on June 17, 2013