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

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01108653
• Other study ID #: REK sør-øst B:2009/719b
• Status: Recruiting
• Phase: N/A
• First received: April 19, 2010
• Last updated: May 6, 2010
• Start date: January 2010
• Est. completion date: December 2012

Study information

• Verified date: January 2010
• Source: Oslo University Hospital
• Contact: Stefan Agewall, Professor, MD.PhD
• Phone: +4722894655
• Email: stefan.agewall[@]medisin.uio.no
• Is FDA regulated: No
• Health authority: Norway: Ethics Committee
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Other:
• Usual care sick-leave management
Patients randomized to usual care. Follow up after discharge by general practitioner (GP) according to local practice.
• Structuralised sick-leave program
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.

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo	Trondheimsveien 235

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Helse Sor-Ost

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No