Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Secondary Prevention of Problems in Health Status in Patients With COPD by Early Detection, Motivational Intervention to Engage in Treatment by the Patient, and by Individualized Treatment
The purpose of this study is to determine the effectiveness of an intervention conducted by
a pulmonary nurse in patients with COPD.
The hypothesis is that in a sample of COPD patients with clinically relevant problems in
health status (physiological functioning, symptoms, functional impairment and quality of
life), a motivational intervention conducted by a pulmonary nurse will lead to
patient-tailored treatment and an improved health status.
Chronic Obstructive Pulmonary Disease (COPD) is a disease state characterized by airflow
that is not fully reversible. Besides problems in physiological functioning, the patient
also can experience symptoms, functional impairment and a diminished quality of life (see
Vercoulen et al., 2008). Problems in the three latter domains of health status are hardly
recognized in usual care, and remain untreated until escalated. This is mainly caused by two
phenomena: doctor delay and patient delay. Doctor delay: the physician does not directly
identify symptoms, functional impairment, and problems in quality of life. Patient delay:
the patient does not report problems in these health status domains.
What is necessary is a screening instrument that can be used in routine care and identifies
patients with problems in the four domains of health status. If clinically relevant problems
exists, and additional treatment is recommended, an intervention by the pulmonary nurse is
indicated. This intervention is directed at increasing awareness of existing problems and
motivating the patient for additional treatment. By means of the screening and intervention,
problems in health status are detected and treated early, before escalation. Treatment is
patient-tailored, based on the existing problems in the four domains of health status,
eventually leading to an improved health status.
A randomized controlled trial is conducted to test the hypothesis described above. Based on
the independent clinical interpretation of the PatientProfileChart (see Peters et al., 2009)
by three professionals, patients are assigned to one of the following groups: 1. Patients
with no clinically relevant problems in health status (group I), and 2. Patients with
clinically relevant problems in health status (group II/III). Patients with clinically
relevant problems in health status are randomized to a control group (group II: usual care
as delivered by the outpatient clinic) and the experimental group (group III: intervention
conducted by a pulmonary nurse, directed at increasing awareness of problems in health
status, increasing motivation to engage in additional treatment, and improving health
status).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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