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

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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?

Official Title
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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

Conditions
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Lung Diseases, Obstructive

Intervention / Treatment
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* Behavioral: an integrated self-management education program
* Behavioral: regular practice nurse review (monitoring controls)
* Behavioral: care at initiative of the patient (usual GP care)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: usual care<br>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)<br>* care at initiative of the patient (usual GP care)<br>|
| Experimental: monitoring controls<br>regular COPD care (monitoring) provided by practice nurse according to current COPD guidelines | Behavioral: regular practice nurse review (monitoring controls)<br>* protocol based on existing Guidelines: Dutch College of General Practitioners (NHG) Global Initiative for Chronic Obstructive Lung Disease (GOLD)<br>|
| Experimental: self-management<br>disease specific self-management program 'Living Well with COPD' | Behavioral: an integrated self-management education program<br>* disease specific self-management program 'Living Well with COPD', developed in Montreal, Canada<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-specific health-related quality of life (HRQoL) |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of exacerbations |  | two years | 
| generic quality of life |  | two years | 
| decline post- and pre-bronchodilator (BD) lung function indices |  | two years | 
| level of respiratory symptoms |  | two years | 
| satisfaction with the health care received |  | two years | 
| compliance with (non-) pharmaceutical treatment |  | two years | 
| direct and indirect medical costs |  | two years | 
| COPD related self-efficacy |  | two years | 
| COPD coping styles |  | two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic obstructive pulmonary disease (COPD), self-management, practice nurse, cost-effectiveness, randomized controlled trial