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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00128765
Enrollment
165
Registered
2005-08-10
Start date
2005-01-31
Completion date
2008-12-31
Last updated
2011-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Diseases, Obstructive

Keywords

chronic obstructive pulmonary disease (COPD), self-management, practice nurse, cost-effectiveness, randomized controlled trial

Brief summary

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

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?

Interventions

BEHAVIORALan integrated self-management education program

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

BEHAVIORALregular practice nurse review (monitoring controls)

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

BEHAVIORALcare at initiative of the patient (usual GP care)

care at initiative of the patient (usual GP care)

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
disease-specific health-related quality of life (HRQoL)two years

Secondary

MeasureTime frame
generic quality of lifetwo years
decline post- and pre-bronchodilator (BD) lung function indicestwo years
level of respiratory symptomstwo years
satisfaction with the health care receivedtwo years
the number of exacerbationstwo years
direct and indirect medical coststwo years
COPD related self-efficacytwo years
COPD coping stylestwo years
compliance with (non-) pharmaceutical treatmenttwo years

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026