Clinical Trial: Costs and Effects of Three Modes for Disease Management of Chronic Obstructive Pulmonary Disease in General Practice.

This study is currently recruiting patients.
Verified by Radboud University August 2005

Sponsors and Collaborators: Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Picasso: Partners in Care Solutions for COPD
Department of Pulmonary Diseases, Radboud University, The Netherlands
Centre for Quality of Care, Radboud University, The Netherlands
Erasmus Medical Center, Rotterdam, The Netherlands
McGill University, Montreal, Canada
Information provided by: Radboud University
ClinicalTrials.gov Identifier: NCT00128765

Purpose

In this randomized controlled trial three contemporary modes for COPD disease management in Dutch general practices are compared for costs and effects: (I) usual general practitioner care (at patient’s initiative); (II) regular practice nurse review; (III) integrated self-management education. All three interventions are based on existing guidelines, materials, and field experiences.
Condition Intervention
Lung Diseases, Obstructive
 Behavior: - an integrated self-management education program
 Behavior: - regular practice nurse review
 Behavior: - care at initiative of the patient (usual GP care)

MedlinePlus related topics:  COPD (Chronic Obstructive Pulmonary Disease)

Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

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.

Further Study Details: 
Primary Outcomes: * disease-specific health-related quality of life (HRQoL)
Secondary Outcomes: * the number of exacerbations;; * generic quality of life; * decline post- and preBD lung function indices; * level of respiratory symptoms; * satisfaction with the health care received; * compliance with (non-)pharmaceutical treatment; * direct and indirect medical costs
Expected Total Enrollment:  165

Study start: January 2005;  Expected completion: July 2008
Last follow-up: December 2007;  Data entry closure: January 2008

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.

  1. 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?
  2. 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 above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • registered in one of the general practices participating in the study;
  • diagnosis of COPD, with GOLD stage I, II or III (see Appendix III);
  • age ≥35 years;
  • willing to provide written informed consent.

Exclusion Criteria:

  • very poor prognosis with regard to the 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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00128765

Erik Bischoff, MD      +31(0)243614611    E.Bischoff@hag.umcn.nl
Tjard Schermer, PhD      +31(0)243614611    T.Schermer@hag.umcn.nl

Netherlands
      Radboud University, Department of General Medicine, Nijmegen,  6500 HB,  Netherlands; Recruiting
Erik Bischoff, MD  +31(0)243614611    E.Bischoff@hag.umcn.nl 
Tjard Schermer, PhD  +31(0)243614611    T.Schermer@hag.umcn.nl 
Erik Bischoff, MD,  Principal Investigator

Study chairs or principal investigators

Chris van Weel, FRCP,  Study Chair,  Department of General Practice, Radboud University, Nijmegen, The Netherlands   
Tjard Schermer, PhD,  Study Director,  Department of General Practice, Radboud University, Nijmegen, The Netherlands   
Erik Bischoff, MD,  Principal Investigator,  Department of General Practice, Radboud University, Nijmegen, The Netherlands   

More Information

Publications

Bourbeau J, Julien M, Maltais F, Rouleau M, Beaupre A, Begin R, Renzi P, Nault D, Borycki E, Schwartzman K, Singh R, Collet JP; Chronic Obstructive Pulmonary Disease axis of the Respiratory Network Fonds de la Recherche en Sante du Quebec. Reduction of hospital utilization in patients with chronic obstructive pulmonary disease: a disease-specific self-management intervention. Arch Intern Med. 2003 Mar 10;163(5):585-91.

Monninkhof E, van der Valk P, van der Palen J, van Herwaarden C, Partridge MR, Zielhuis G. Self-management education for patients with chronic obstructive pulmonary disease: a systematic review. Thorax. 2003 May;58(5):394-8. Review.

Bourbeau J, Nault D, Dang-Tan T. Self-management and behaviour modification in COPD . Patient Educ Couns. 2004 Mar;52(3):271-7.

Study ID Numbers:  MONC95582; ZonMw grant: 945.04.230; Picasso grant: 005.2004; CMO: 2004/249
Last Updated:  August 9, 2005
Record first received:  August 9, 2005
ClinicalTrials.gov Identifier:  NCT00128765
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
ClinicalTrials.gov processed this record on 2005-08-23



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