NCT01522001

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2011

Longer than P75 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 31, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

May 29, 2015

Status Verified

September 1, 2012

Enrollment Period

3.5 years

First QC Date

January 26, 2012

Last Update Submit

May 28, 2015

Conditions

Acute Coronary SyndromeMyocardial IschemiaAcute Myocardial Infarction: Rehabilitation Phase

Keywords

Acute Coronary SyndromeMyocardial IschemiaShared CareRehabilitationCommunityCardiac RehabilitationHospital

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • 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

  • +6 more secondary outcomes

Study Arms (2)

Hospital-based

NO INTERVENTION

* 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.

Shared care Model

ACTIVE COMPARATOR

* 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

Interventions

Shared Care modelBEHAVIORAL

* 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.

Shared care Model

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Silkeborg Hospital

Silkeborg, Region Midt, 8600, Denmark

Location

Aarhus University Hospital. Department of Cardiology and Medicine

Aarhus, 8000, Denmark

Location

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

Viborg, 8800, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 29531754DERIVED

  • 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.

    PMID: 27566597DERIVED

MeSH Terms

Conditions

Acute Coronary SyndromeMyocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Jannik B Bertelsen, MD

    Hjertemedicinsk Afdeling B, Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2012

First Posted

January 31, 2012

Study Start

October 1, 2011

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

May 29, 2015

Record last verified: 2012-09

Locations

DK(3)