Shared Care Rehabilitation After Acute Coronary Syndrome

NCT ID: NCT01522001

Last Updated: 2015-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 212 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2015-04-30

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.

Conditions

Acute Coronary Syndrome; Myocardial Ischemia; Acute Myocardial Infarction: Rehabilitation Phase

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Shared Care model

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region MidtJylland Denmark

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jannik B Bertelsen, MD

Role: PRINCIPAL_INVESTIGATOR

Hjertemedicinsk Afdeling B, Aarhus University Hospital

Locations

Silkeborg Hospital

Silkeborg, Region Midt, Denmark

Aarhus University Hospital. Department of Cardiology and Medicine

Aarhus, , Denmark

Viborg Hospital, Hospital Unit of Viborg, Silkeborg, Hammel and Skive

Viborg, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 29531754 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27566597 (View on PubMed)

Other Identifiers

SHARED REHAB

Identifier Type: -

Identifier Source: org_study_id