Costs and Effects of Three Modes for Disease Management of Chronic Obstructive Pulmonary Disease in General Practice

This study has been completed.
Sponsor:
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
PICASSO: Partners in Care Solutions for COPD
Erasmus Medical Center
McGill University
Information provided by (Responsible Party):
E. Bischoff, Radboud University
ClinicalTrials.gov Identifier:
NCT00128765
First received: August 9, 2005
Last updated: November 21, 2011
Last verified: November 2011
  Purpose

In this randomized controlled trial, three contemporary modes for chronic obstructive pulmonary disease (COPD) management in Dutch general practices are compared for costs and effects:

  • usual general practitioner (GP) care (at patient's initiative);
  • regular practice nurse review; and
  • integrated self-management education.

All three interventions are based on existing guidelines, materials, and field experiences.


Condition Intervention
Lung Diseases, Obstructive
Behavioral: an integrated self-management education program
Behavioral: regular practice nurse review (monitoring controls)
Behavioral: care at initiative of the patient (usual GP care)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Costs and Effects of Three Modes for Disease Management of Chronic Obstructive Pulmonary Disease (COPD) in General Practice. A Randomized Controlled Trial Comparing Regular Practice Nurse Review, Self-management Education and Usual Care

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • disease-specific health-related quality of life (HRQoL) [ Time Frame: two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the number of exacerbations [ Time Frame: two years ] [ Designated as safety issue: No ]
  • generic quality of life [ Time Frame: two years ] [ Designated as safety issue: No ]
  • decline post- and pre-bronchodilator (BD) lung function indices [ Time Frame: two years ] [ Designated as safety issue: No ]
  • level of respiratory symptoms [ Time Frame: two years ] [ Designated as safety issue: No ]
  • satisfaction with the health care received [ Time Frame: two years ] [ Designated as safety issue: No ]
  • compliance with (non-) pharmaceutical treatment [ Time Frame: two years ] [ Designated as safety issue: No ]
  • direct and indirect medical costs [ Time Frame: two years ] [ Designated as safety issue: No ]
  • COPD related self-efficacy [ Time Frame: two years ] [ Designated as safety issue: No ]
  • COPD coping styles [ Time Frame: two years ] [ Designated as safety issue: No ]

Enrollment: 165
Study Start Date: January 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: usual care
usual care, i.e. COPD care at patient's own initiative, mostly for medical help during exacerbations
Behavioral: care at initiative of the patient (usual GP care)
care at initiative of the patient (usual GP care)
Experimental: monitoring controls
regular COPD care (monitoring) provided by practice nurse according to current COPD guidelines
Behavioral: regular practice nurse review (monitoring controls)
protocol based on existing Guidelines: Dutch College of General Practitioners (NHG) Global Initiative for Chronic Obstructive Lung Disease (GOLD)
Experimental: self-management
disease specific self-management program 'Living Well with COPD'
Behavioral: an integrated self-management education program
disease specific self-management program 'Living Well with COPD', developed in Montreal, Canada

Detailed Description:

Considering the ageing of the Dutch population and the current and increasing shortage of general practitioners (GPs), the capacity of primary healthcare is a major and growing concern. Delegation of care normally provided by GPs with care provided by trained practice nurses is now rapidly emerging for patients with chronic respiratory disease, i.e. asthma and chronic obstructive pulmonary disease (COPD). However, most general practices still provide care at initiative of the patient self, because of the lack in scientific evidence and the costs of implementing a regular care structure. Self-care by patients may be an alternative to alleviate the growing load on primary health care.

The following two main research questions are addressed in this study.

  • Does an integrated self-management education intervention for patients with COPD in general practice contribute to attaining long-term treatment targets, compared to regular monitoring by a practice nurse and usual GP care?
  • What is the cost-effectiveness of an integrated self-management education intervention for patients with COPD, compared to regular monitoring by a practice nurse and usual GP care?
  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Registered in one of the general practices participating in the study
  • Diagnosis of COPD, with Global Initiative for Chronic Obstructive Lung Diseases (GOLD) stage I, II or III
  • Age ≥35 years
  • Willing to provide written informed consent

Exclusion Criteria:

  • Very poor prognosis with regard to respiratory condition (GOLD stage IV)
  • Severe co-morbid conditions with a reduced life expectancy
  • Unable to communicate in the Dutch language
  • Objections to one or more of the disease management modes in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00128765

Locations
Netherlands
Radboud University, Department of General Medicine
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
PICASSO: Partners in Care Solutions for COPD
Erasmus Medical Center
McGill University
Investigators
Study Chair: Chris van Weel, FRCP Department of General Practice, Radboud University, Nijmegen, The Netherlands
Study Director: Tjard Schermer, PhD Department of General Practice, Radboud University, Nijmegen, The Netherlands
Principal Investigator: Erik Bischoff, MD Department of General Practice, Radboud University, Nijmegen, The Netherlands
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: E. Bischoff, MD MSc, Radboud University
ClinicalTrials.gov Identifier: NCT00128765     History of Changes
Other Study ID Numbers: MONC95582, ZonMw grant: 945.04.230, Picasso grant: 005.2004, CMO: 2004/249
Study First Received: August 9, 2005
Last Updated: November 21, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
chronic obstructive pulmonary disease (COPD)
self-management
practice nurse
cost-effectiveness
randomized controlled trial

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

ClinicalTrials.gov processed this record on July 22, 2014