Myocardial InfarctionNCT01108653
A Structuralised Sick-leave Program Compared to Usual Care Sick Leave Management in Patients After an Acute Myocardial Infarction
A study testing Structuralised sick-leave program in people with Myocardial Infarction, run by Oslo University Hospital at 1 site in Norway.
Trial summary
In this study the investigators aim at comparing the effect on quality of life and the cost-effectiveness of a structuralised sick-leave program compared to usual care sick leave management in patients after an acute non ST myocardial infarction(NSTEMI).The investigators hypothesize that a structuralised sick-leave… Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Structuralised sick-leave program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2010to Dec 2012
- Phase
- Interventional
- 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 Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with acute NSTEMI who are revascularized.
- 65 years old or less
- Self caring
- Adequately literate in Norwegian
- Have a regular work in at least 50% position.
Who cannot join
- Patients not willing to participate
- Professional drivers
- Patients with alcohol or drug abuse
- Severe complications after the myocardial infarction such as malignant arrythmias, heart failure and major bleedings.
- Patients with recent CABG ( coronary artery bypass graft operation) within the last 6 months.
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo, Trondheimsveien 235, 0514
Stefan Agewall, Professor
About this study
In this study the investigators aim at comparing the effect on quality of life and the cost-effectiveness of a structuralised sick-leave program compared to usual care sick leave management in patients after an acute non ST myocardial infarction(NSTEMI).The investigators hypothesize that a structuralised sick-leave program after an acute NSTEMI is cost-effective without a negative effect on quality of life compared to usual care management in this patient group.
- Conditions
- Myocardial Infarction
- Being tested
- Usual care sick-leave management, Structuralised sick-leave program
- Keywords
- Cardiovascular diseases, Heart diseases, Myocardial infarction, Rehabilitation, Health Economy, Randomized controlled trials, Non ST Elevation Myocardial Infarction (NSTEMI), Cost analysis, Sick-leave, Quality of Life
- Medical subject headings
- Myocardial Infarction, Cardiovascular Diseases, Heart Diseases, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual care sick-leave managementOther
Patients randomized to usual care. Follow up after discharge by general practitioner (GP) according to local practice.
Structuralised sick-leave programOther
Patients randomized to the structuralized program will get full time sick-leave for 2 weeks after discharge.Cardiologist will be responsible for individual adaption of each patient's sick-leave and follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Usual care sick-leave management | Other | Not described Receives: Other: Usual care sick-leave management |
| Group 2: Structuralised sick-leave program | Other | Not described Receives: Other: Structuralised sick-leave program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost effectiveness
In order to evaluate resource use (costs) all patients will be asked to fill in a questionnaire at baseline and after 6 and 12 months. Total costs and mean costs will be calculated in the two different follow-up modalities.
Measured: one year
Secondary outcomes (1)
Quality of Life measures are estimated at baseline and after 6 and 12 months using the standard Medical Outcomes Study Short form( SF-36)questionnaire and the disease-specific Utility-Based Quality of life-Heart questionnaire(UBQ-H).
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Sor-Ost
- Investigators
- Stefan Agewall, Professor, Principal investigator, Oslo University Hospital. Department of Cardiology. Trondheimsveien 235, 0514 Oslo, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01108653
- Sponsor's protocol ID
- REK sør-øst B:2009/719b
- Status last verified
- Jan 2010
- First submitted
- 19 Apr 2010
- Last updated
- 7 May 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Structuralised Sick-leave Program Compared to Usual Care Sick Leave Management in Patients After an Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT01108653
- Acronym / sponsor ID
- REK sør-øst B:2009/719b
- Conditions
- Myocardial Infarction
- Keywords
- Cardiovascular diseases, Heart diseases, Myocardial infarction, Rehabilitation, Health Economy, Randomized controlled trials, Non ST Elevation Myocardial Infarction (NSTEMI), Cost analysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Helse Sor-Ost
- Study start
- Jan 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 22 Apr 2010 (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.
In this study the investigators aim at comparing the effect on quality of life and the cost-effectiveness of a structuralised sick-leave program compared to usual care sick leave management in patients after an acute non ST myocardial infarction(NSTEMI).The investigators hypothesize that a structuralised sick-leave program after an acute NSTEMI is cost-effective without a negative effect on quality of life compared to usual care management in this patient group.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Usual care sick-leave management | Other | Other: Usual care sick-leave management |
| Group 2: Structuralised sick-leave program | Other | Other: Structuralised sick-leave program |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with acute NSTEMI who are revascularized.
- 65 years old or less
- Self caring
- Adequately literate in Norwegian
- Have a regular work in at least 50% position.
Key exclusion criteria (5 listed)
- Patients not willing to participate
- Professional drivers
- Patients with alcohol or drug abuse
- Severe complications after the myocardial infarction such as malignant arrythmias, heart failure and major bleedings.
- Patients with recent CABG ( coronary artery bypass graft operation) within the last 6 months.
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 |
|---|---|---|
| Usual care sick-leave managementPatients randomized to usual care. Follow up after discharge by general practitioner (GP) according to local practice. | Other | Group 1: Usual care sick-leave management |
| Structuralised sick-leave programPatients randomized to the structuralized program will get full time sick-leave for 2 weeks after discharge.Cardiologist will be responsible for individual adaption of each patient's sick-leave and follow-up. | Other | Group 2: Structuralised sick-leave program |
Primary outcome
Cost effectiveness
Time frame: one year
In order to evaluate resource use (costs) all patients will be asked to fill in a questionnaire at baseline and after 6 and 12 months. Total costs and mean costs will be calculated in the two different follow-up modalities.
1 secondary outcome
Quality of Life measures are estimated at baseline and after 6 and 12 months using the standard Medical Outcomes Study Short form( SF-36)questionnaire and the disease-specific Utility-Based Quality of life-Heart questionnaire(UBQ-H).
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2010.
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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.
Stefan Agewall, Professor principal investigator
Oslo University Hospital. Department of Cardiology. Trondheimsveien 235, 0514 Oslo, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structuralised sick-leave program in people with Myocardial Infarction, run by Oslo University Hospital at 1 site in Norway.
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 5 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: status not confirmed, as of the sponsor's last update on 7 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefan Agewall, Professor, MD.PhD (+4722894655, stefan.agewall@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost effectiveness (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2010.