Clinical trial NCT00940355: Secondary Prevention of Problems in Health Status in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Health Status
Keywords: COPD
Health Status
Intervention
Secondary prevention
patient-tailored treatment
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: PICASSO: Partners in Care Solutions for COPD
First posted: 2009-07-16
Enrollment: 303
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* Diagnosis of COPD
* Written informed consent

Exclusion Criteria:

* Not able to adhere to study protocol
* Not competent enough in understanding Dutch language
* Participation in pulmonary rehabilitation program within previous 6 months
* Current participation in other research study in COPD

Primary outcomes:
measure: Physiological Functioning: TLC% predicted, RV% predicted, FEV1% predicted, BMI
timeFrame: T0 (baseline), T1 (after 6 months) T2 (after 12 months). T0: group I/II/III T1: group II/III T2 group I/II/III
measure: Symptoms: Physical Activity Rating Scale Dyspnoea- Global Dyspnoea Activity and Global Dyspnoea Burden, Dyspnoea Emotions Questionnaire - Frustration and Anxiety, Checklist Individual Strength - Fatigue
timeFrame: T0 (baseline), T1 (after 6 months) T2 (after 12 months). T0: group I/II/III T1: group II/III T2 group I/II/III
measure: Quality of Life: Beck Depression Inventory Primary Care, Satisfaction with Life Scale, Satisfaction Physical, Satisfaction Future, Satisfaction Spouse and Satisfaction Social
timeFrame: T0 (baseline), T1 (after 6 months) T2 (after 12 months). T0: group I/II/III T1: group II/III T2 group I/II/III
measure: Functional Impairment: Quality of Life for Respiratory Illness Questionnaire - General Activities, Sickness Impact Profile - Home Management and Ambulation
timeFrame: T0 (baseline), T1 (after 6 months) T2 (after 12 months). T0: group I/II/III T1: group II/III T2 group I/II/III
measure: The number of additional treatments
timeFrame: T0 (baseline), T1 (after 6 months) T2 (after 12 months). T0: group I/II/III T1: group II/III T2 group I/II/III
Secondary outcomes:
measure: Smoking status
timeFrame: T0 (baseline), T1 (after 6 months) T2 (after 12 months). T0: group I/II/III T1: group II/III T2 group I/II/III
measure: Patient satisfaction with treatment
timeFrame: T1 (after 6 months) T2 (after 12 months). T1: group II/III T2 group I/II/III
measure: Sociodemographic variables (i.e. sex, age, education, personal situation, work situation)
timeFrame: T0 (baseline), T1 (after 6 months) T2 (after 12 months). T0: group I/II/III T1: group II/III T2 group I/II/III
measure: Clinical variables (i.e. comorbidity, previous and current treatments, hospitalization)
timeFrame: T0 (baseline), T1 (after 6 months) T2 (after 12 months). T0: group I/II/III T1: group II/III T2 group I/II/III
measure: Accuracy of diagnostic properties of the PatientProfileChart
timeFrame: T0 (baseline), T0: group I/II/III
Other outcomes:
Locations:
city: Groesbeek
country: Netherlands
facility: Radboud University Nijmegen Medical Center, department of Pulmonary Diseases
Study officials:
affiliation: Radboud University Nijmegen Medical Center, department of Medical Psychology & department of Pulmonary Diseases
name: Leonie Daudey, MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Nijmegen Medical Center, department of Medical Psychology & department of Pulmonary Diseases
name: Jan Vercoulen, Dr.
role: STUDY_DIRECTOR
affiliation: Radboud University NIjmegen Medical Center, Department of Medical Psychology & department of Pulmonary Diseases
name: Jan Vercoulen, Dr.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.