Shared Care Rehabilitation After Acute Coronary Syndrome (SHARED-REHAB)

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia; Acute Coronary Syndrome; Acute Myocardial Infarction: Rehabilitation Phase
• Intervention / Treatment: Behavioral: Shared Care model

• Study Type: Interventional
• Enrollment (Actual): 212
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Aarhus University Hospital. Department of Cardiology and Medicine
  • Viborg, Denmark, 8800
    • Viborg Hospital, Hospital Unit of Viborg, Silkeborg, Hammel and Skive
  • Region Midt
    • Silkeborg, Region Midt, Denmark, 8600
      • Silkeborg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Hospital-based; 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; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Region MidtJylland Denmark
• Investigators: Principal Investigator: Jannik B Bertelsen, MD, Hjertemedicinsk Afdeling B, Aarhus University Hospital

Publications and helpful links

General Publications

• Bertelsen JB, Dehbarez NT, Refsgaard J, Kanstrup H, Johnsen SP, Qvist I, Christensen B, Sogaard R, Christensen KL. Shared care versus hospital-based cardiac rehabilitation: a cost-utility analysis based on a randomised controlled trial. Open Heart. 2018 Feb 7;5(1):e000584. doi: 10.1136/openhrt-2016-000584. eCollection 2018.
• Bertelsen JB, Refsgaard J, Kanstrup H, Johnsen SP, Qvist I, Christensen B, Christensen KL. Cardiac rehabilitation after acute coronary syndrome comparing adherence and risk factor modification in a community-based shared care model versus hospital-based care in a randomised controlled trial with 12 months of follow-up. Eur J Cardiovasc Nurs. 2017 Apr;16(4):334-343. doi: 10.1177/1474515116666781. Epub 2016 Sep 23.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: January 26, 2012
• First Submitted That Met QC Criteria: January 26, 2012
• First Posted (Estimate): January 31, 2012

Study Record Updates

• Last Update Posted (Estimate): May 29, 2015
• Last Update Submitted That Met QC Criteria: May 28, 2015
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Rehabilitation; Hospital; Acute Coronary Syndrome; Cardiac Rehabilitation; Myocardial Ischemia; Community; Shared Care
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease; Coronary Disease; Myocardial Infarction; Infarction; Coronary Artery Disease; Myocardial Ischemia; Syndrome; Ischemia; Acute Coronary Syndrome
• Other Study ID Numbers: SHARED REHAB