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

This study is currently recruiting participants.
Verified September 2012 by University of Aarhus
Sponsor:
Collaborator:
Region MidtJylland Denmark
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01522001
First received: January 26, 2012
Last updated: September 14, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Acute Coronary Syndrome
Myocardial Ischemia
Acute Myocardial Infarction: Rehabilitation Phase
 Behavioral: Shared Care model
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Shared Care Rehabilitation After Acute Coronary Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Participation in cardiac rehabilitation [ Time Frame: 4 months ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Change of BMI and / or abdominal circumference [ Time Frame: 4 and 12 months ] [ Designated as safety issue: No ]
  • 24-hour Ambulatory Blood Pressure [ Time Frame: 4 og 12 months ] [ Designated as safety issue: No ]
  • Blood Cholesterol values (Total, LDL, HDL) [ Time Frame: 4 and 12 months ] [ Designated as safety issue: No ]
  • Fasting Blood glucose [ Time Frame: 4 and 12 months ] [ Designated as safety issue: No ]
  • Exercise Capacity [ Time Frame: 4 and 12 months ] [ Designated as safety issue: No ]
  • Lifestyle changes [ Time Frame: 4 and 12 months ] [ Designated as safety issue: No ]
    Diet, Physical Activity, Smoking, Alcohol consumption.

  • Depression score [ Time Frame: 4 and 12 months ] [ Designated as safety issue: No ]
    Estimated by Hospital Anxiety and Depression Scale

  • Compliance to pharmaceutical treatment [ Time Frame: 4 and 12 months ] [ Designated as safety issue: No ]
  • Readmission [ Time Frame: 4 and 12 months ] [ Designated as safety issue: No ]
    Total and cardiovascular

  • Change in Health Related Quality of Living [ Time Frame: 4 and 12 months ] [ Designated as safety issue: No ]
    SF-12 HeartQoL EQ-5D

  • Difference in Health economic costs [ Time Frame: 4 and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 208
Study Start Date: October 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01522001

Contacts
Contact: Jannik B Bertelsen, MD +4589497695 ext +4541196151 jannbert@rm.dk
Contact: Kent L Christensen, MD +4589497150 ext +4520189229 kentchri@rm.dk

Locations
Denmark
Silkeborg Hospital Recruiting
Silkeborg, Region Midt, Denmark, 8600
Contact: Lars Frost, MD, ph.d         larfrost@rm.dk    
Aarhus University Hospital. Department of Cardiology and Medicine Recruiting
Aarhus, Denmark, 8000
Sub-Investigator: Kent L Christensen, MD            
Viborg Hospital, Hospital Unit of Viborg, Silkeborg, Hammel and Skive Recruiting
Viborg, Denmark, 8800
Contact: Jens Refsgaard, MD, ph.d         jennrefs@viborg.rm.dk    
Sponsors and Collaborators
University of Aarhus
Region MidtJylland Denmark
Investigators
Principal Investigator: Jannik B Bertelsen, MD Hjertemedicinsk Afdeling B, Aarhus University Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01522001     History of Changes
Other Study ID Numbers: SHARED REHAB
Study First Received: January 26, 2012
Last Updated: September 14, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Acute Coronary Syndrome
Myocardial Ischemia
Shared Care
Rehabilitation
 Community
Cardiac Rehabilitation
Hospital

Additional relevant MeSH terms:
Myocardial Ischemia
Coronary Artery Disease
Infarction
Ischemia
Myocardial Infarction
Acute Coronary Syndrome
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
 Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes
Necrosis
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013