Shared Care Rehabilitation After Acute Coronary Syndrome (SHARED-REHAB)
|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.|
|ClinicalTrials.gov Identifier: NCT01522001|
Recruitment Status : Completed
First Posted : January 31, 2012
Last Update Posted : May 29, 2015
Cardiac rehabilitation is an individual adapted multidisciplinary intervention for people suffering from Heart Disease. It involves;
- Dietary counseling,
- Exercise training,
- Psychosocial support,
- smoking cessation
- Patient education
The purpose is quick and complete recovery and to reduce the chance of recurrence.
In Denmark people admitted with Acute Cardiac Disease is referred to a course of hospital based cardiac rehabilitation at discharge.
The Danish Municipal Reform of 2007 changed the responsibility of rehabilitation from the Regions, who runs the hospitals, to the municipalities.
Shared care is in this setting that elements of treatment are completed different places in Health Care.
The aim of this study is:
- to establish a shared care model for Cardiac rehabilitation following admission with Acute Coronary Syndrome and
- to compare this model to the existing hospital based cardiac rehabilitation after admission with Acute Coronary Syndrome.
Primary outcome is participation in cardiac rehabilitation.
|Condition or disease||Intervention/treatment||Phase|
|Acute Coronary Syndrome Myocardial Ischemia Acute Myocardial Infarction: Rehabilitation Phase||Behavioral: Shared Care model||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||212 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Shared Care Rehabilitation After Acute Coronary Syndrome|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
No Intervention: Hospital-based
Active Comparator: Shared care Model
Behavioral: Shared Care model
- Participation in cardiac rehabilitation [ Time Frame: 4 months ]
Participation in cardiac rehabilitation is evaluated for each element. Participation is defined as at least 50% for each element.
- Smoking cessation
- Dietary counseling
- Exercise training
- Patient education
- Psychosocial support
Full participation is in 6 of 6 elements if smoker or 5/5 if non-smoker. Partial full participation is in 5/6 if smoker or 4/5 if non-smoker.
- Change of BMI and / or abdominal circumference [ Time Frame: 4 and 12 months ]
- 24-hour Ambulatory Blood Pressure [ Time Frame: 4 og 12 months ]
- Blood Cholesterol values (Total, LDL, HDL) [ Time Frame: 4 and 12 months ]
- Fasting Blood glucose [ Time Frame: 4 and 12 months ]
- Exercise Capacity [ Time Frame: 4 and 12 months ]
- Lifestyle changes [ Time Frame: 4 and 12 months ]Diet, Physical Activity, Smoking, Alcohol consumption.
- Depression score [ Time Frame: 4 and 12 months ]Estimated by Hospital Anxiety and Depression Scale
- Compliance to pharmaceutical treatment [ Time Frame: 4 and 12 months ]
- Readmission [ Time Frame: 4 and 12 months ]Total and cardiovascular
- Change in Health Related Quality of Living [ Time Frame: 4 and 12 months ]SF-12 HeartQoL EQ-5D
- Difference in Health economic costs [ Time Frame: 4 and 12 months ]
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): NCT01522001
|Silkeborg, Region Midt, Denmark, 8600|
|Aarhus University Hospital. Department of Cardiology and Medicine|
|Aarhus, Denmark, 8000|
|Viborg Hospital, Hospital Unit of Viborg, Silkeborg, Hammel and Skive|
|Viborg, Denmark, 8800|
|Principal Investigator:||Jannik B Bertelsen, MD||Hjertemedicinsk Afdeling B, Aarhus University Hospital|