Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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