Costs and Effects of Three Modes for Disease Management of Chronic Obstructive Pulmonary Disease in General Practice
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|ClinicalTrials.gov Identifier: NCT00128765|
Recruitment Status : Completed
First Posted : August 10, 2005
Last Update Posted : November 22, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Diseases, Obstructive||Behavioral: an integrated self-management education program Behavioral: regular practice nurse review (monitoring controls) Behavioral: care at initiative of the patient (usual GP care)||Not Applicable|
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?
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||165 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||December 2008|
Active Comparator: usual care
usual care, i.e. COPD care at patient's own initiative, mostly for medical help during exacerbations
Behavioral: care at initiative of the patient (usual GP care)
care at initiative of the patient (usual GP care)
Experimental: monitoring controls
regular COPD care (monitoring) provided by practice nurse according to current COPD guidelines
Behavioral: regular practice nurse review (monitoring controls)
protocol based on existing Guidelines: Dutch College of General Practitioners (NHG) Global Initiative for Chronic Obstructive Lung Disease (GOLD)
disease specific self-management program 'Living Well with COPD'
Behavioral: an integrated self-management education program
disease specific self-management program 'Living Well with COPD', developed in Montreal, Canada
- disease-specific health-related quality of life (HRQoL) [ Time Frame: two years ]
- the number of exacerbations [ Time Frame: two years ]
- generic quality of life [ Time Frame: two years ]
- decline post- and pre-bronchodilator (BD) lung function indices [ Time Frame: two years ]
- level of respiratory symptoms [ Time Frame: two years ]
- satisfaction with the health care received [ Time Frame: two years ]
- compliance with (non-) pharmaceutical treatment [ Time Frame: two years ]
- direct and indirect medical costs [ Time Frame: two years ]
- COPD related self-efficacy [ Time Frame: two years ]
- COPD coping styles [ Time Frame: two years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00128765
|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|