Cost-effectiveness of Outpatient Versus Hospital Cardiac Rehabilitation (CERC1)
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|ClinicalTrials.gov 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
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
|Condition or disease||Intervention/treatment||Phase|
|Coronary Heart Disease||Behavioral: Cardiac rehabilitation||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Hospital cardiac rehabilitation
The patients will perform physical training sessions in the hospital
Behavioral: Cardiac rehabilitation
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.
- Morbidity [ Time Frame: 1 year ]Readmissions, percutaneous or surgical revascularization
- Cost [ Time Frame: 1 year ]
- 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).
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT01567189
|Contact: Fernando Aros Borau||+34 945 007000||LUISFDO.AROSBORAU@osakidetza.net|
|Araba University Hospital||Not yet recruiting|
|Vitoria, Álava, Spain, 01009|