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Completed

NCT Number: NCT01522001

Shared Care Rehabilitation After Acute Coronary Syndrome

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.

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Key information

Conditions

Acute Coronary Syndrome Acute Myocardial Infarction: Rehabilitation Phase Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Silkeborg Hospital, Silkeborg, Region Midt, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Shared Care model

Behavioral
  • 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.

Primary outcomes

  1. 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
    • 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 outcomes

  1. Change of BMI and / or abdominal circumference

    Time frame: 4 and 12 months

  2. 24-hour Ambulatory Blood Pressure

    Time frame: 4 og 12 months

  3. Blood Cholesterol values (Total, LDL, HDL)

    Time frame: 4 and 12 months

  4. Fasting Blood glucose

    Time frame: 4 and 12 months

  5. Exercise Capacity

    Time frame: 4 and 12 months

  6. Lifestyle changes

    Time frame: 4 and 12 months

    Diet, Physical Activity, Smoking, Alcohol consumption.

  7. Depression score

    Time frame: 4 and 12 months

    Estimated by Hospital Anxiety and Depression Scale

  8. Compliance to pharmaceutical treatment

    Time frame: 4 and 12 months

  9. Readmission

    Time frame: 4 and 12 months

    Total and cardiovascular

  10. Change in Health Related Quality of Living

    Time frame: 4 and 12 months

    SF-12 HeartQoL EQ-5D

  11. Difference in Health economic costs

    Time frame: 4 and 12 months

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Region MidtJylland Denmark

Registry information

Acronym: SHARED-REHAB

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jan 31, 2012
Registry last updated
May 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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