Shared Care Rehabilitation After Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

— SHARED-REHAB  

Official title:

Shared Care Rehabilitation After Acute Coronary Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01522001
• Other study ID #: SHARED REHAB
• Status: Completed
• Phase: Phase 4
• First received: January 26, 2012
• Last updated: May 28, 2015
• Start date: October 2011
• Est. completion date: April 2015

Study information

• Verified date: September 2012
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Myocardial Infarction: Rehabilitation Phase
• Coronary Artery Disease
• Myocardial Infarction
• Myocardial Ischemia
• Syndrome

Intervention

Behavioral:
• Shared Care model
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.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital. Department of Cardiology and Medicine	Aarhus
Denmark	Silkeborg Hospital	Silkeborg	Region Midt
Denmark	Viborg Hospital, Hospital Unit of Viborg, Silkeborg, Hammel and Skive	Viborg

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Region MidtJylland Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change of BMI and / or abdominal circumference		4 and 12 months	No
Secondary	24-hour Ambulatory Blood Pressure		4 og 12 months	No
Secondary	Blood Cholesterol values (Total, LDL, HDL)		4 and 12 months	No
Secondary	Fasting Blood glucose		4 and 12 months	No
Secondary	Exercise Capacity		4 and 12 months	No
Secondary	Lifestyle changes	Diet, Physical Activity, Smoking, Alcohol consumption.	4 and 12 months	No
Secondary	Depression score	Estimated by Hospital Anxiety and Depression Scale	4 and 12 months	No
Secondary	Compliance to pharmaceutical treatment		4 and 12 months	No
Secondary	Readmission	Total and cardiovascular	4 and 12 months	No
Secondary	Change in Health Related Quality of Living	SF-12 HeartQoL EQ-5D	4 and 12 months	No
Secondary	Difference in Health economic costs		4 and 12 months	No