Shared Care Rehabilitation After Acute Coronary Syndrome

Study Overview
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Brief Summary
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Cardiac rehabilitation is an individual adapted multidisciplinary intervention for people suffering from Heart Disease. It involves; Dietary counseling, Exercise training, Psychosocial support, Physician 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.

Official Title
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Shared Care Rehabilitation After Acute Coronary Syndrome

Conditions
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Acute Coronary Syndrome, Myocardial Ischemia, Acute Myocardial Infarction: Rehabilitation Phase

Intervention / Treatment
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* Behavioral: Shared Care model


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admission with Acute Coronary Syndrome Resident in district of Department of Cardiology, Aarhus University Hospital, Silkeborg or Viborg Hospital, part of the Hospitalsenheden Midt Viborg, Silkeborg, Skive, Hammel. Accept both models of cardiac rehabilitation written informed consent Exclusion Criteria: Resident outside the district of Department of Cardiology, Aarhus University Hospital, Viborg Hospital or Silkeborg Hospital, part of Hospitalsenheden Midt (Viborg, Silkeborg, Skive, Hammel). Age 80 years or older Heart Failure (Ejection Fraction less than 40%) Severe Comorbidity Resuscitated and need of support from ergotherapist after discharge.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Hospital-based<br>First visit at cardiac ambulatory approximately 14 days after discharge includes physician examination by cardiologist and counseling from nurse specialized in cardiac rehabilitation. Dietary counseling with dietician Exercise (1 hour, 2 timer pr week for 12 weeks) Smoking cessation if smoker with educated smoking cessation instructor Patient education and psychosocial support in 2 to 3 individual consultations with nurse specialized in cardiac rehabilitation Examination by cardiologist 8-12 weeks after discharge. | |
| Active Comparator: Shared care Model<br>First visit at cardiac ambulatory approximately 14 days after discharge includes examination by cardiologist and counseling from nurse specialized in cardiac rehabilitation. Dietary counseling with dietician Exercise (1 hour, 2 timer pr week for 12 weeks) Smoking cessation if smoker with educated smoking cessation instructor Patient education and psychosocial support in 2 individual consultations and 8 group based consultations with experienced nurse Examination by the patient´s general practitioner 8-12 weeks after discharge. | Behavioral: Shared Care model<br>* First visit at cardiac ambulatory approximately 14 days after discharge includes physician examination by cardiologist and counseling from nurse specialized in cardiac rehabilitation. Dietary counseling with dietician Exercise (1 hour, 2 timer pr week for 12 weeks) Smoking cessation if smoker with educated smoking cessation instructor Patient education and psychosocial support in 2 individual consultations and 8 group based consultations with experienced nurse Examination by the patient´s general practitioner 8-12 weeks after discharge.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participation in cardiac rehabilitation | 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 Physician 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. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of BMI and / or abdominal circumference |  | 4 and 12 months | 
| 24-hour Ambulatory Blood Pressure |  | 4 og 12 months | 
| Blood Cholesterol values (Total, LDL, HDL) |  | 4 and 12 months | 
| Fasting Blood glucose |  | 4 and 12 months | 
| Exercise Capacity |  | 4 and 12 months | 
| Lifestyle changes | Diet, Physical Activity, Smoking, Alcohol consumption. | 4 and 12 months | 
| Depression score | Estimated by Hospital Anxiety and Depression Scale | 4 and 12 months | 
| Compliance to pharmaceutical treatment |  | 4 and 12 months | 
| Readmission | Total and cardiovascular | 4 and 12 months | 
| Change in Health Related Quality of Living | SF-12 HeartQoL EQ-5D | 4 and 12 months | 
| Difference in Health economic costs |  | 4 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Coronary Syndrome, Myocardial Ischemia, Shared Care, Rehabilitation, Community, Cardiac Rehabilitation, Hospital