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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 |
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Information provided by: | Radboud University |
ClinicalTrials.gov Identifier: | NCT00128765 |
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:
All three interventions are based on existing guidelines, materials, and field experiences.
Condition | Intervention |
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Lung Diseases, Obstructive |
Behavioral: an integrated self-management education program Behavioral: regular practice nurse review Behavioral: care at initiative of the patient (usual GP care) |
Study Type: | Interventional |
Study Design: | Randomized, Single Blind (Outcomes Assessor), 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 |
Estimated Enrollment: | 165 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | August 2008 |
Arms | Assigned Interventions |
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A: Active Comparator
usual care
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Behavioral: care at initiative of the patient (usual GP care) |
B: Active Comparator
regular COPD care provided by practice nurse
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Behavioral: regular practice nurse review
protocol based on existing Guidelines: Dutch College of General Practitioners (NHG) Global Initiative for Chronic Obstructive Lung Disease (GOLD)
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C: Experimental
disease specific self-management program 'Living Well with COPD'
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Behavioral: an integrated self-management education program
disease specific self-management program 'Living Well with COPD', developed in Montreal, Canada
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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.
Ages Eligible for Study: | 35 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Netherlands | |
Radboud University, Department of General Medicine | |
Nijmegen, Netherlands, 6500 HB |
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 |
Study ID Numbers: | MONC95582, ZonMw grant: 945.04.230, Picasso grant: 005.2004, CMO: 2004/249 |
Study First Received: | August 9, 2005 |
Last Updated: | October 3, 2007 |
ClinicalTrials.gov Identifier: | NCT00128765 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
chronic obstructive pulmonary disease (COPD) self-management practice nurse cost-effectiveness randomized controlled trial |
Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Pulmonary Disease, Chronic Obstructive |