Lung Diseases, Obstructive Clinical Trial
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
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.
Status | Completed |
Enrollment | 165 |
Est. completion date | December 2008 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 35 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)
Country | Name | City | State |
---|---|---|---|
Netherlands | Radboud University, Department of General Medicine | Nijmegen |
Lead Sponsor | Collaborator |
---|---|
Radboud University | Erasmus Medical Center, McGill University, PICASSO: Partners in Care Solutions for COPD, ZonMw: The Netherlands Organisation for Health Research and Development |
Netherlands,
Bourbeau J, Julien M, Maltais F, Rouleau M, Beaupré A, Bégin 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 Santé du Québec. 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. — View Citation
Bourbeau J, Nault D, Dang-Tan T. Self-management and behaviour modification in COPD . Patient Educ Couns. 2004 Mar;52(3):271-7. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | disease-specific health-related quality of life (HRQoL) | two years | No | |
Secondary | the number of exacerbations | two years | No | |
Secondary | generic quality of life | two years | No | |
Secondary | decline post- and pre-bronchodilator (BD) lung function indices | two years | No | |
Secondary | level of respiratory symptoms | two years | No | |
Secondary | satisfaction with the health care received | two years | No | |
Secondary | compliance with (non-) pharmaceutical treatment | two years | No | |
Secondary | direct and indirect medical costs | two years | No | |
Secondary | COPD related self-efficacy | two years | No | |
Secondary | COPD coping styles | two years | No |
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