Shared Care Rehabilitation After Acute Coronary Syndrome
Shared Care Rehabilitation After Acute Coronary Syndrome
Sponsors
Source
University of Aarhus
Oversight Info
Has Dmc
No
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.
Overall Status
Completed
Start Date
2011-10-01
Completion Date
2015-04-01
Primary Completion Date
2015-04-01
Phase
Phase 4
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Participation in cardiac rehabilitation |
4 months |
Secondary Outcome
Measure |
Time Frame |
|
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 |
|
Lifestyle changes |
4 and 12 months |
|
Depression score |
4 and 12 months |
|
Compliance to pharmaceutical treatment |
4 and 12 months |
|
Readmission |
4 and 12 months |
|
Change in Health Related Quality of Living |
4 and 12 months |
|
Difference in Health economic costs |
4 and 12 months |
Enrollment
212
Conditions
Intervention
Intervention Type
Behavioral
Intervention Name
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.
Arm Group Label
Shared care Model
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.
Gender
All
Minimum Age
18 Years
Maximum Age
79 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Jannik B Bertelsen, MD |
Principal Investigator |
Hjertemedicinsk Afdeling B, Aarhus University Hospital |
Location
Facility |
|
Silkeborg Hospital Silkeborg Region Midt 8600 Denmark |
|
Aarhus University Hospital. Department of Cardiology and Medicine Aarhus 8000 Denmark |
|
Viborg Hospital, Hospital Unit of Viborg, Silkeborg, Hammel and Skive Viborg 8800 Denmark |
Location Countries
Country
Denmark
Verification Date
2012-09-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Arm Group
Arm Group Label
Hospital-based
Arm Group Type
No 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 to 3 individual consultations with nurse specialized in cardiac rehabilitation
Examination by cardiologist 8-12 weeks after discharge.
Arm Group Label
Shared care Model
Arm Group Type
Active Comparator
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.
Firstreceived Results Date
N/A
Acronym
SHARED-REHAB
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)
Study First Submitted
January 26, 2012
Study First Submitted Qc
January 26, 2012
Study First Posted
January 31, 2012
Last Update Submitted
May 28, 2015
Last Update Submitted Qc
May 28, 2015
Last Update Posted
May 29, 2015
ClinicalTrials.gov processed this data on December 12, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.