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

Not Applicable

• Conditions: Myocardial Infarction
• Interventions: Other: Usual care sick-leave management; Other: Structuralised sick-leave program

• Registration Number: NCT01108653
• Lead Sponsor: Oslo University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-01
• Study Start: 2010-01
• Study First Submitted: 2010-04-19
• Study First Submitted QC: 2010-04-20
• Study First Posted: 2010-04-22
• Last Update Submitted: 2010-05-06
• Last Update Posted: 2010-05-07
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: Usual care sick-leave management	Usual care sick-leave management	-
Group 2: Structuralised sick-leave program	Structuralised sick-leave program	-

Primary Outcome Measures

Name	Time	Method
Cost effectiveness	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.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Trondheimsveien 235, Norway