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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
History of Changes
  Purpose

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 Intervention
Myocardial Infarction
 Other: Usual care sick-leave management
Other: Structuralised sick-leave program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: January 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   up to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 19, 2010
Last Updated: May 6, 2010
Health Authority: Norway: Ethics Committee

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

ClinicalTrials.gov processed this record on May 16, 2013