NCT00940355|Completed
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Sponsor study identifier
Secondary identifiers
interventional
303
1 country
1
Study Start
September 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2009
Actual (reported)Study Completion
October 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2007
Date type not reportedThis date has not been verified as actual or estimated.
July 15, 2009
Actual (reported)July 16, 2009
Actual (reported)October 2009
Actual (reported)October 2009
Actual (reported)Physiological Functioning: TLC% predicted, RV% predicted, FEV1% predicted, BMI
T0 (baseline), T1 (after 6 months) T2 (after 12 months). T0: group I/II/III T1: group II/III T2 group I/II/III
Symptoms: Physical Activity Rating Scale Dyspnoea- Global Dyspnoea Activity and Global Dyspnoea Burden, Dyspnoea Emotions Questionnaire - Frustration and Anxiety, Checklist Individual Strength - Fatigue
T0 (baseline), T1 (after 6 months) T2 (after 12 months). T0: group I/II/III T1: group II/III T2 group I/II/III
Quality of Life: Beck Depression Inventory Primary Care, Satisfaction with Life Scale, Satisfaction Physical, Satisfaction Future, Satisfaction Spouse and Satisfaction Social
T0 (baseline), T1 (after 6 months) T2 (after 12 months). T0: group I/II/III T1: group II/III T2 group I/II/III
Functional Impairment: Quality of Life for Respiratory Illness Questionnaire - General Activities, Sickness Impact Profile - Home Management and Ambulation
Smoking status
T0 (baseline), T1 (after 6 months) T2 (after 12 months). T0: group I/II/III T1: group II/III T2 group I/II/III
Patient satisfaction with treatment
T1 (after 6 months) T2 (after 12 months). T1: group II/III T2 group I/II/III
Sociodemographic variables (i.e. sex, age, education, personal situation, work situation)
T0 (baseline), T1 (after 6 months) T2 (after 12 months). T0: group I/II/III T1: group II/III T2 group I/II/III
Clinical variables (i.e. comorbidity, previous and current treatments, hospitalization)
T0 (baseline), T1 (after 6 months) T2 (after 12 months). T0: group I/II/III T1: group II/III T2 group I/II/III
Accuracy of diagnostic properties of the PatientProfileChart
T0 (baseline), T0: group I/II/III
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.
group II: usual care as delivered by the outpatient clinic.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Radboud University Nijmegen Medical Center, department of Pulmonary Diseases
Groesbeek, 6560 AB, Netherlands
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.
Leonie Daudey, MSc.
Radboud University Nijmegen Medical Center, department of Medical Psychology & department of Pulmonary Diseases
Jan Vercoulen, Dr.
Radboud University Nijmegen Medical Center, department of Medical Psychology & department of Pulmonary Diseases
Jan Vercoulen, Dr.
Radboud University NIjmegen Medical Center, Department of Medical Psychology & department of Pulmonary Diseases
303 participants (actual enrollment reported by the registry).
First Submitted
July 15, 2009
First Posted
July 16, 2009
Study Start
September 2007
Date type not reportedThis date has not been verified as actual or estimated.
T0 (baseline), T1 (after 6 months) T2 (after 12 months). T0: group I/II/III T1: group II/III T2 group I/II/III
The number of additional treatments
T0 (baseline), T1 (after 6 months) T2 (after 12 months). T0: group I/II/III T1: group II/III T2 group I/II/III
Contact the study team to confirm eligibility.
Primary Completion
October 2009
Actual (reported)Study Completion
October 2009
Actual (reported)Last Updated
January 20, 2010
Record last verified: 2009-07
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Source: ClinicalTrials.gov.
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