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Clinical Trials/NCT01512836
NCT01512836
Completed
Not Applicable

A Randomized Controlled Trial to Determine Outcome and Cost Effectiveness of Case Management of Patients Suffering From Chronic Obstructive Pulmonary Disease (COPD) in a Danish Setting

Kronikerenheden Nordjylland1 site in 1 country150 target enrollmentJuly 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Sponsor
Kronikerenheden Nordjylland
Enrollment
150
Locations
1
Primary Endpoint
COPD hospitalization rates
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

This randomized controlled trial (RCT) will examine a nurse case management model for patients suffering from chronic obstructive pulmonary disease (COPD) in a Danish municipality, and is performed in order to evaluate the use of case management as a tool in achieving integrated, quality and cost-effective care for this group of patients.

The main objectives are to evaluate how case management influences on hospital admissions, mortality, quality of life and self care, as well as to compare costs and cost-effectiveness of case management vs. usual care.

Detailed Description

Case management is being implemented as a health service strategy that should contribute to maximize health outcomes within a cost-constrained environment. Evaluations of case management in Danish settings are sparse, and so far no Danish studies have evaluated the cost-effectiveness of case management. This study is performed as a RCT, and the study focuses exclusively on patients with COPD. The patients will be enrolled and randomized after being referred to rehabilitation at the local rehabilitation center in Aalborg municipality, Denmark. 150 patients will be randomly assigned to two groups of 75 patients each. Participants in the control group will receive usual care, whereas patients assigned to the interventional group will receive case management besides their usual care. Each patient will be followed for 12 months. Patients in both groups will fill out questionnaires at baseline and 12 months. The data register system "Health - Planning and Quality" in the Northern Region of Jutland will be used to determine health care services and costs.

Registry
clinicaltrials.gov
Start Date
July 2012
End Date
January 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kronikerenheden Nordjylland
Responsible Party
Principal Investigator
Principal Investigator

Sabrina Storgaard Soerensen

Ph.d. student

Kronikerenheden Nordjylland

Eligibility Criteria

Inclusion Criteria

  • Patients who are clinically referred to rehabilitation at Aalborg Rehabilitation Center for their diagnosed COPD

Exclusion Criteria

  • Patients living outside Aalborg municipality, or who is considering to move to another municipality or country in near future.
  • Patients without a telephone
  • Patients with dementia
  • Patients participating in other research studies

Outcomes

Primary Outcomes

COPD hospitalization rates

Time Frame: 1 year (study inclusion - 12 months of follow-up)

Secondary Outcomes

  • Mortality(1 year (study inclusion - 12 months of follow-up))
  • Self Care(A baseline measure at study inclusion and after 12 months of follow-up)
  • Quality of Life (QoL)(A baseline measure at study inclusion and after 12 months of follow-up)
  • Cost-effectiveness of case management(1 year)

Study Sites (1)

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