Secondary Prevention of Problems in Health Status in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT ID: NCT00940355
Last Updated: 2010-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
303 participants
INTERVENTIONAL
2007-09-30
2009-10-31
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Intervention pulmonary nurse
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.
Intervention pulmonary nurse
The intervention is conducted by a pulmonary nurse, directed at increasing awareness of problems in health status, and increasing motivation to engage in additional treatment, and improving health status.
Usual care
group II: usual care as delivered by the outpatient clinic.
No interventions assigned to this group
Interventions
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Intervention pulmonary nurse
The intervention is conducted by a pulmonary nurse, directed at increasing awareness of problems in health status, and increasing motivation to engage in additional treatment, and improving health status.
Eligibility Criteria
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Inclusion Criteria
* Written informed consent
Exclusion Criteria
* Not competent enough in understanding Dutch language
* Participation in pulmonary rehabilitation program within previous 6 months
* Current participation in other research study in COPD
18 Years
ALL
No
Sponsors
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PICASSO: Partners in Care Solutions for COPD
OTHER
Radboud University Medical Center
OTHER
Responsible Party
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Radboud University Nijmegen Medical Center
Principal Investigators
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Leonie Daudey, MSc.
Role: PRINCIPAL_INVESTIGATOR
Radboud University Nijmegen Medical Center, department of Medical Psychology & department of Pulmonary Diseases
Jan Vercoulen, Dr.
Role: STUDY_DIRECTOR
Radboud University Nijmegen Medical Center, department of Medical Psychology & department of Pulmonary Diseases
Jan Vercoulen, Dr.
Role: STUDY_CHAIR
Radboud University NIjmegen Medical Center, Department of Medical Psychology & department of Pulmonary Diseases
Locations
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Radboud University Nijmegen Medical Center, department of Pulmonary Diseases
Groesbeek, , Netherlands
Countries
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References
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Vercoulen JH, Daudey L, Molema J, Vos PJ, Peters JB, Top M, Folgering H. An Integral assessment framework of health status in chronic obstructive pulmonary disease (COPD). Int J Behav Med. 2008;15(4):263-79. doi: 10.1080/10705500802365474.
Peters JB, Daudey L, Heijdra YF, Molema J, Dekhuijzen PN, Vercoulen JH. Development of a battery of instruments for detailed measurement of health status in patients with COPD in routine care: the Nijmegen Clinical Screening Instrument. Qual Life Res. 2009 Sep;18(7):901-12. doi: 10.1007/s11136-009-9502-2. Epub 2009 Jun 19.
Other Identifiers
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NTR1844
Identifier Type: -
Identifier Source: secondary_id
PICASSO 06-009
Identifier Type: -
Identifier Source: org_study_id
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