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

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ClinicalTrials.gov Identifier: NCT01108653
Recruitment Status : Unknown
Verified January 2010 by Oslo University Hospital.
Recruitment status was:  Recruiting
First Posted : April 22, 2010
Last Update Posted : May 7, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Myocardial Infarction Other: Usual care sick-leave management Other: Structuralised sick-leave program

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Structuralised Sick-leave Program Compared to Usual Care Sick Leave Management in Patients After an Acute Myocardial Infarction
Study Start Date : January 2010
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.
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.


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  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). [ Time Frame: one year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01108653


Contacts
Contact: Stefan Agewall, Professor, MD.PhD +4722894655 stefan.agewall@medisin.uio.no
Contact: Liv Mundal, MD +4793268387 liv.mundal@oslo-universitetssykehus.no

Locations
Norway
Oslo University Hospital Recruiting
Oslo, Trondheimsveien 235, Norway, 0514
Principal Investigator: Stefan Agewall, Professor         
Sponsors and Collaborators
Oslo University Hospital
Helse Sor-Ost
Investigators
Principal Investigator: Stefan Agewall, Professor Oslo University Hospital. Department of Cardiology. Trondheimsveien 235, 0514 Oslo, Norway
More Information

Responsible Party: Oslo University Hospital. Trondheimsveien 235,0514 Oslo, Norway.(Professor Stefan Agewall), Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01108653     History of Changes
Other Study ID Numbers: REK sør-øst B:2009/719b
First Posted: April 22, 2010    Key Record Dates
Last Update Posted: May 7, 2010
Last Verified: January 2010

Keywords provided by Oslo University Hospital:
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

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases