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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Basque Health Service.
Recruitment status was  Not yet recruiting
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

February 22, 2012
March 28, 2012
April 2012
April 2013   (final data collection date for primary outcome measure)
  • 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).
Same as current
Complete list of historical versions of study NCT01567189 on ClinicalTrials.gov Archive Site
  • 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
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
138
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.
Both
18 Years and older
No
Contact: Fernando Aros Borau +34 945 007000 LUISFDO.AROSBORAU@osakidetza.net
Spain
 
NCT01567189
CERC1
No
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