Secondary Prevention of Problems in Health Status in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; Health Status
• Intervention / Treatment: Behavioral: Intervention pulmonary nurse

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).

• Study Type: Interventional
• Enrollment (Actual): 303
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Groesbeek, Netherlands, 6560 AB
    • Radboud University Nijmegen Medical Center, department of Pulmonary Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: Usual care; group II: usual care as delivered by the outpatient clinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: PICASSO: Partners in Care Solutions for COPD
• Investigators: Principal Investigator: Leonie Daudey, MSc., Radboud University NIjmegen Medical Center, Department of Medical Psychology & department of Pulmonary Diseases; Study Director: Jan Vercoulen, Dr., Radboud University NIjmegen Medical Center, Department of Medical Psychology & department of Pulmonary Diseases; Study Chair: Jan Vercoulen, Dr., Radboud University NIjmegen Medical Center, Department of Medical Psychology & department of Pulmonary Diseases

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: July 15, 2009
• First Submitted That Met QC Criteria: July 15, 2009
• First Posted (Estimate): July 16, 2009

Study Record Updates

• Last Update Posted (Estimate): January 20, 2010
• Last Update Submitted That Met QC Criteria: January 19, 2010
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: COPD; Health Status; Intervention; Secondary prevention; patient-tailored treatment
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: PICASSO 06-009; NTR1844