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)

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

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?

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

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

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   

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