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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Oslo University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Helse Sor-Ost
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01108653
First received: April 19, 2010
Last updated: May 6, 2010
Last verified: January 2010

April 19, 2010
May 6, 2010
January 2010
December 2012   (final data collection date for primary outcome measure)
Cost effectiveness [ Time Frame: one year ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01108653 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Structuralised Sick-leave Program Compared to Usual Care Sick Leave Management in Patients After an Acute Myocardial Infarction
A Structuralised Sick-leave Program Compared to Usual Care Sick Leave Management in Patients After an Acute Myocardial Infarction

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Myocardial Infarction
  • Other: Usual care sick-leave management
    Patients randomized to usual care. Follow up after discharge by general practitioner (GP) according to local practice.
  • 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.
  • Group 1: Usual care sick-leave management
    Intervention: Other: Usual care sick-leave management
  • Group 2: Structuralised sick-leave program
    Intervention: Other: Structuralised sick-leave program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
up to 65 Years
No
Contact: Stefan Agewall, Professor, MD.PhD +4722894655 stefan.agewall@medisin.uio.no
Contact: Liv Mundal, MD +4793268387 liv.mundal@oslo-universitetssykehus.no
Norway
 
NCT01108653
REK sør-øst B:2009/719b
Not Provided
Oslo University Hospital. Trondheimsveien 235,0514 Oslo, Norway.(Professor Stefan Agewall), Oslo University Hospital
Oslo University Hospital
Helse Sor-Ost
Principal Investigator: Stefan Agewall, Professor Oslo University Hospital. Department of Cardiology. Trondheimsveien 235, 0514 Oslo, Norway
Oslo University Hospital
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP