Clinical trial NCT01522001: Shared Care Rehabilitation After Acute Coronary Syndrome
Official title: Shared Care Rehabilitation After Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Myocardial Ischemia
Acute Myocardial Infarction: Rehabilitation Phase
Keywords: Acute Coronary Syndrome
Myocardial Ischemia
Shared Care
Rehabilitation
Community
Cardiac Rehabilitation
Hospital
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Region MidtJylland Denmark
First posted: 2012-01-31
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Participation in cardiac rehabilitation
timeFrame: 4 months
Secondary outcomes:
measure: Change of BMI and / or abdominal circumference
timeFrame: 4 and 12 months
measure: 24-hour Ambulatory Blood Pressure
timeFrame: 4 og 12 months
measure: Blood Cholesterol values (Total, LDL, HDL)
timeFrame: 4 and 12 months
measure: Fasting Blood glucose
timeFrame: 4 and 12 months
measure: Exercise Capacity
timeFrame: 4 and 12 months
measure: Lifestyle changes
timeFrame: 4 and 12 months
measure: Depression score
timeFrame: 4 and 12 months
measure: Compliance to pharmaceutical treatment
timeFrame: 4 and 12 months
measure: Readmission
timeFrame: 4 and 12 months
measure: Change in Health Related Quality of Living
timeFrame: 4 and 12 months
measure: Difference in Health economic costs
timeFrame: 4 and 12 months
Other outcomes:
Locations:
city: Silkeborg
country: Denmark
facility: Silkeborg Hospital
state: Region Midt
city: Aarhus
country: Denmark
facility: Aarhus University Hospital. Department of Cardiology and Medicine
city: Viborg
country: Denmark
facility: Viborg Hospital, Hospital Unit of Viborg, Silkeborg, Hammel and Skive
Study officials:
affiliation: Hjertemedicinsk Afdeling B, Aarhus University Hospital
name: Jannik B Bertelsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.