A Structuralised Sick-leave Program Compared to Usual Care Sick Leave Management in Patients After an Acute Myocardial Infarction
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 19, 2010
CompletedFirst Posted
Study publicly available on registry
April 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedMay 7, 2010
January 1, 2010
2.9 years
April 19, 2010
May 6, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cost effectiveness
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 Outcomes (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).
one year
Study Arms (2)
Group 1: Usual care sick-leave management
OTHERGroup 2: Structuralised sick-leave program
OTHERInterventions
Patients randomized to usual care. Follow up after discharge by general practitioner (GP) according to local practice.
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 Criteria
You may qualify if:
- Patients with acute NSTEMI who are revascularized.
- years old or less
- Self caring
- Adequately literate in Norwegian
- Have a regular work in at least 50% position.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oslo University Hospitallead
- Helse Sor-Ostcollaborator
Study Sites (1)
Oslo University Hospital
Oslo, Trondheimsveien 235, 0514, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefan Agewall, Professor
Oslo University Hospital. Department of Cardiology. Trondheimsveien 235, 0514 Oslo, Norway
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 19, 2010
First Posted
April 22, 2010
Study Start
January 1, 2010
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
May 7, 2010
Record last verified: 2010-01