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

Primary Purpose

Myocardial Infarction

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Usual care sick-leave management
Structuralised sick-leave program
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Myocardial Infarction focused on measuring 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

Eligibility Criteria

undefined - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Oslo University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Group 1: Usual care sick-leave management

Group 2: Structuralised sick-leave program

Arm Description

Outcomes

Primary Outcome Measures

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.

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).

Full Information

First Posted
April 19, 2010
Last Updated
May 6, 2010
Sponsor
Oslo University Hospital
Collaborators
Helse Sor-Ost
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1. Study Identification

Unique Protocol Identification Number
NCT01108653
Brief Title
A Structuralised Sick-leave Program Compared to Usual Care Sick Leave Management in Patients After an Acute Myocardial Infarction
Official Title
A Structuralised Sick-leave Program Compared to Usual Care Sick Leave Management in Patients After an Acute Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Oslo University Hospital
Collaborators
Helse Sor-Ost

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Usual care sick-leave management
Arm Type
Other
Arm Title
Group 2: Structuralised sick-leave program
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Usual care sick-leave management
Intervention Description
Patients randomized to usual care. Follow up after discharge by general practitioner (GP) according to local practice.
Intervention Type
Other
Intervention Name(s)
Structuralised sick-leave program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cost effectiveness
Description
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.
Time Frame
one year
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan Agewall, Professor, MD.PhD
Phone
+4722894655
Email
stefan.agewall@medisin.uio.no
First Name & Middle Initial & Last Name or Official Title & Degree
Liv Mundal, MD
Phone
+4793268387
Email
liv.mundal@oslo-universitetssykehus.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Agewall, Professor
Organizational Affiliation
Oslo University Hospital. Department of Cardiology. Trondheimsveien 235, 0514 Oslo, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
State/Province
Trondheimsveien 235
ZIP/Postal Code
0514
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Agewall, Professor

12. IPD Sharing Statement

Learn more about this trial

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

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