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

This study has been completed.
Sponsor:
Collaborator:
PICASSO: Partners in Care Solutions for COPD
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00940355
First received: July 15, 2009
Last updated: January 19, 2010
Last verified: July 2009
History of Changes
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease
Health Status
 Behavioral: Intervention pulmonary nurse

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Physiological Functioning: TLC% predicted, RV% predicted, FEV1% predicted, BMI [ Time Frame: T0 (baseline), T1 (after 6 months) T2 (after 12 months). T0: group I/II/III T1: group II/III T2 group I/II/III ] [ Designated as safety issue: No ]
  • Symptoms: Physical Activity Rating Scale Dyspnoea- Global Dyspnoea Activity and Global Dyspnoea Burden, Dyspnoea Emotions Questionnaire - Frustration and Anxiety, Checklist Individual Strength - Fatigue [ Time Frame: T0 (baseline), T1 (after 6 months) T2 (after 12 months). T0: group I/II/III T1: group II/III T2 group I/II/III ] [ Designated as safety issue: No ]
  • Quality of Life: Beck Depression Inventory Primary Care, Satisfaction with Life Scale, Satisfaction Physical, Satisfaction Future, Satisfaction Spouse and Satisfaction Social [ Time Frame: T0 (baseline), T1 (after 6 months) T2 (after 12 months). T0: group I/II/III T1: group II/III T2 group I/II/III ] [ Designated as safety issue: No ]
  • Functional Impairment: Quality of Life for Respiratory Illness Questionnaire - General Activities, Sickness Impact Profile - Home Management and Ambulation [ Time Frame: T0 (baseline), T1 (after 6 months) T2 (after 12 months). T0: group I/II/III T1: group II/III T2 group I/II/III ] [ Designated as safety issue: No ]
  • The number of additional treatments [ Time Frame: T0 (baseline), T1 (after 6 months) T2 (after 12 months). T0: group I/II/III T1: group II/III T2 group I/II/III ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Smoking status [ Time Frame: T0 (baseline), T1 (after 6 months) T2 (after 12 months). T0: group I/II/III T1: group II/III T2 group I/II/III ] [ Designated as safety issue: No ]
  • Patient satisfaction with treatment [ Time Frame: T1 (after 6 months) T2 (after 12 months). T1: group II/III T2 group I/II/III ] [ Designated as safety issue: No ]
  • Sociodemographic variables (i.e. sex, age, education, personal situation, work situation) [ Time Frame: T0 (baseline), T1 (after 6 months) T2 (after 12 months). T0: group I/II/III T1: group II/III T2 group I/II/III ] [ Designated as safety issue: No ]
  • Clinical variables (i.e. comorbidity, previous and current treatments, hospitalization) [ Time Frame: T0 (baseline), T1 (after 6 months) T2 (after 12 months). T0: group I/II/III T1: group II/III T2 group I/II/III ] [ Designated as safety issue: No ]
  • Accuracy of diagnostic properties of the PatientProfileChart [ Time Frame: T0 (baseline), T0: group I/II/III ] [ Designated as safety issue: No ]

Enrollment: 303
Study Start Date: September 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00940355

Locations
Netherlands
Radboud University Nijmegen Medical Center, department of Pulmonary Diseases
Groesbeek, Netherlands, 6560 AB
Sponsors and Collaborators
Radboud University
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
  More Information

Publications:

Responsible Party: Dr. J.H.M.M. Vercoulen, Radboud University Nijmegen Medical Center
ClinicalTrials.gov Identifier: NCT00940355     History of Changes
Other Study ID Numbers: PICASSO 06-009, NTR1844
Study First Received: July 15, 2009
Last Updated: January 19, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
COPD
Health Status
Intervention
Secondary prevention
patient-tailored treatment

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013