A Structuralised Sick-leave Program Compared to Usual Care Sick Leave Management in Patients After an Acute Myocardial Infarction

Study Overview
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Brief Summary
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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.

Official Title
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A Structuralised Sick-leave Program Compared to Usual Care Sick Leave Management in Patients After an Acute Myocardial Infarction

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Other: Usual care sick-leave management
* Other: Structuralised sick-leave program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1: Usual care sick-leave management<br> | Other: Usual care sick-leave management<br>* Patients randomized to usual care. Follow up after discharge by general practitioner (GP) according to local practice.<br>|
| Other: Group 2: Structuralised sick-leave program<br> | Other: Structuralised sick-leave program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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