Acute Coronary SyndromePhase 4SHARED-REHABNCT01522001
Shared Care Rehabilitation After Acute Coronary Syndrome
A Phase 4 study testing Shared Care model in people with Acute Coronary Syndrome and Myocardial Ischemia, run by University of Aarhus at 3 sites in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Acute Coronary Syndrome, Myocardial Ischemia, Acute Myocardial Infarction: Rehabilitation Phase
- What is being tested?
- Shared Care model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 3 sitesDenmark
- Study dates
- Oct 2011to Apr 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Aarhus University Hospital. Department of Cardiology and Medicine
Aarhus, 8000
Silkeborg Hospital
Silkeborg, Region Midt, 8600
Viborg Hospital, Hospital Unit of Viborg, Silkeborg, Hammel and Skive
Viborg, 8800
About this study
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
Read more
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
- Being tested
- Shared Care model
- Keywords
- Acute Coronary Syndrome, Myocardial Ischemia, Shared Care, Rehabilitation, Community, Cardiac Rehabilitation, Hospital
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared Care modelBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Shared Care model |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (11)
Change of BMI and / or abdominal circumference
Measured: 4 and 12 months
24-hour Ambulatory Blood Pressure
Measured: 4 og 12 months
Blood Cholesterol values (Total, LDL, HDL)
Measured: 4 and 12 months
Fasting Blood glucose
Measured: 4 and 12 months
Exercise Capacity
Measured: 4 and 12 months
Lifestyle changes
Diet, Physical Activity, Smoking, Alcohol consumption.
Measured: 4 and 12 months
Depression score
Estimated by Hospital Anxiety and Depression Scale
Measured: 4 and 12 months
Compliance to pharmaceutical treatment
Measured: 4 and 12 months
Readmission
Total and cardiovascular
Measured: 4 and 12 months
Change in Health Related Quality of Living
SF-12 HeartQoL EQ-5D
Measured: 4 and 12 months
Difference in Health economic costs
Measured: 4 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startOct 2011
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Region MidtJylland Denmark
- Responsible party
- Sponsor
- Investigators
- Jannik B Bertelsen, MD, Principal investigator, Hjertemedicinsk Afdeling B, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522001
- Sponsor's protocol ID
- SHARED REHAB
- Acronym
- SHARED-REHAB
- Status last verified
- Sep 2012
- First submitted
- 26 Jan 2012
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29531754Bertelsen 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.
PubMed 27566597
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Care Rehabilitation After Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT01522001
- Acronym / sponsor ID
- SHARED-REHAB / SHARED REHAB
- Conditions
- Acute Coronary Syndrome, Myocardial Ischemia, Acute Myocardial Infarction: Rehabilitation Phase
- Keywords
- Acute Coronary Syndrome, Myocardial Ischemia, Shared Care, Rehabilitation, Community, Cardiac Rehabilitation, Hospital
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Region MidtJylland Denmark
- Study start
- Oct 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 31 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: 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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Shared care Model |
Primary outcome
Participation in cardiac rehabilitation
Time frame: 4 months
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.
11 secondary outcomes
Change of BMI and / or abdominal circumference
Time frame: 4 and 12 months
24-hour Ambulatory Blood Pressure
Time frame: 4 og 12 months
Blood Cholesterol values (Total, LDL, HDL)
Time frame: 4 and 12 months
Fasting Blood glucose
Time frame: 4 and 12 months
Exercise Capacity
Time frame: 4 and 12 months
Lifestyle changes
Time frame: 4 and 12 months
Depression score
Time frame: 4 and 12 months
Compliance to pharmaceutical treatment
Time frame: 4 and 12 months
Readmission
Time frame: 4 and 12 months
Change in Health Related Quality of Living
Time frame: 4 and 12 months
Difference in Health economic costs
Time frame: 4 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2015.
- Derived from this study: PubMed 29531754Bertelsen 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.
- Derived from this study: PubMed 27566597Bertelsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jannik B Bertelsen, MD principal investigator
Hjertemedicinsk Afdeling B, Aarhus University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Shared Care model in people with Acute Coronary Syndrome and Myocardial Ischemia, run by University of Aarhus at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation in cardiac rehabilitation (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01522001, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2015.