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

May 6, 2010 updated by: Oslo University Hospital
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Norway
    • Trondheimsveien 235
      • Oslo, Trondheimsveien 235, Norway, 0514
        • Recruiting
        • Oslo University Hospital
        • Principal Investigator:
          • Stefan Agewall, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one year

Secondary Outcome Measures

Outcome Measure
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).
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

Helse Sor-Ost

Investigators

  • Principal Investigator: Stefan Agewall, Professor, Oslo University Hospital. Department of Cardiology. Trondheimsveien 235, 0514 Oslo, Norway

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

April 19, 2010

First Submitted That Met QC Criteria

April 20, 2010

First Posted (Estimate)

April 22, 2010

Study Record Updates

Last Update Posted (Estimate)

May 7, 2010

Last Update Submitted That Met QC Criteria

May 6, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REK sør-øst B:2009/719b

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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