Skip to content

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01108653
Enrollment
120
Registered
2010-04-22
Start date
2010-01-31
Completion date
2012-12-31
Last updated
2010-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

Keywords

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

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.

Interventions

OTHERUsual care sick-leave management

Patients randomized to usual care. Follow up after discharge by general practitioner (GP) according to local practice.

OTHERStructuralised 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.

Sponsors

Helse Sor-Ost
CollaboratorOTHER_GOV
Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Cost effectivenessone yearIn 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

MeasureTime 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).one year

Countries

Norway

Contacts

Primary ContactStefan Agewall, Professor, MD.PhD
stefan.agewall@medisin.uio.no+4722894655
Backup ContactLiv Mundal, MD
liv.mundal@oslo-universitetssykehus.no+4793268387

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026