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OpenTrials
Completed

NCT Number: NCT00128765

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

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.

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Key information

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboud University, Department of General Medicine

Nijmegen, 6500 HB, Netherlands

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

an integrated self-management education program

Behavioral

disease specific self-management program 'Living Well with COPD', developed in Montreal, Canada

regular practice nurse review (monitoring controls)

Behavioral

protocol based on existing Guidelines: Dutch College of General Practitioners (NHG) Global Initiative for Chronic Obstructive Lung Disease (GOLD)

care at initiative of the patient (usual GP care)

Behavioral

care at initiative of the patient (usual GP care)

Primary outcomes

  1. disease-specific health-related quality of life (HRQoL)

    Time frame: two years

Secondary outcomes

  1. the number of exacerbations

    Time frame: two years

  2. generic quality of life

    Time frame: two years

  3. decline post- and pre-bronchodilator (BD) lung function indices

    Time frame: two years

  4. level of respiratory symptoms

    Time frame: two years

  5. satisfaction with the health care received

    Time frame: two years

  6. compliance with (non-) pharmaceutical treatment

    Time frame: two years

  7. direct and indirect medical costs

    Time frame: two years

  8. COPD related self-efficacy

    Time frame: two years

  9. COPD coping styles

    Time frame: two years

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Erasmus Medical Center
  • McGill University
  • PICASSO: Partners in Care Solutions for COPD
  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Aug 10, 2005
Registry last updated
Nov 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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