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

Primary Purpose

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

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Shared Care model
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Coronary Syndrome focused on measuring Acute Coronary Syndrome, Myocardial Ischemia, Shared Care, Rehabilitation, Community, Cardiac Rehabilitation, Hospital

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Silkeborg Hospital
  • Aarhus University Hospital. Department of Cardiology and Medicine
  • Viborg Hospital, Hospital Unit of Viborg, Silkeborg, Hammel and Skive

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Hospital-based

Shared care Model

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change of BMI and / or abdominal circumference
24-hour Ambulatory Blood Pressure
Blood Cholesterol values (Total, LDL, HDL)
Fasting Blood glucose
Exercise Capacity
Lifestyle changes
Diet, Physical Activity, Smoking, Alcohol consumption.
Depression score
Estimated by Hospital Anxiety and Depression Scale
Compliance to pharmaceutical treatment
Readmission
Total and cardiovascular
Change in Health Related Quality of Living
SF-12 HeartQoL EQ-5D
Difference in Health economic costs

Full Information

First Posted
January 26, 2012
Last Updated
May 28, 2015
Sponsor
University of Aarhus
Collaborators
Region MidtJylland Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT01522001
Brief Title
Shared Care Rehabilitation After Acute Coronary Syndrome
Acronym
SHARED-REHAB
Official Title
Shared Care Rehabilitation After Acute Coronary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Region MidtJylland Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Myocardial Ischemia, Acute Myocardial Infarction: Rehabilitation Phase
Keywords
Acute Coronary Syndrome, Myocardial Ischemia, Shared Care, Rehabilitation, Community, Cardiac Rehabilitation, Hospital

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
212 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hospital-based
Arm Type
No Intervention
Arm Description
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.
Arm Title
Shared care Model
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Shared Care model
Intervention Description
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 Outcome Measure Information:
Title
Participation in cardiac rehabilitation
Description
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.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Change of BMI and / or abdominal circumference
Time Frame
4 and 12 months
Title
24-hour Ambulatory Blood Pressure
Time Frame
4 og 12 months
Title
Blood Cholesterol values (Total, LDL, HDL)
Time Frame
4 and 12 months
Title
Fasting Blood glucose
Time Frame
4 and 12 months
Title
Exercise Capacity
Time Frame
4 and 12 months
Title
Lifestyle changes
Description
Diet, Physical Activity, Smoking, Alcohol consumption.
Time Frame
4 and 12 months
Title
Depression score
Description
Estimated by Hospital Anxiety and Depression Scale
Time Frame
4 and 12 months
Title
Compliance to pharmaceutical treatment
Time Frame
4 and 12 months
Title
Readmission
Description
Total and cardiovascular
Time Frame
4 and 12 months
Title
Change in Health Related Quality of Living
Description
SF-12 HeartQoL EQ-5D
Time Frame
4 and 12 months
Title
Difference in Health economic costs
Time Frame
4 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jannik B Bertelsen, MD
Organizational Affiliation
Hjertemedicinsk Afdeling B, Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Silkeborg Hospital
City
Silkeborg
State/Province
Region Midt
ZIP/Postal Code
8600
Country
Denmark
Facility Name
Aarhus University Hospital. Department of Cardiology and Medicine
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Viborg Hospital, Hospital Unit of Viborg, Silkeborg, Hammel and Skive
City
Viborg
ZIP/Postal Code
8800
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
29531754
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.
Results Reference
derived
PubMed Identifier
27566597
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.
Results Reference
derived

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Shared Care Rehabilitation After Acute Coronary Syndrome

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