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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00128765
• Other study ID #: MONC95582
• Secondary ID: ZonMw grant: 945
• Status: Completed
• Phase: N/A
• First received: August 9, 2005
• Last updated: November 21, 2011
• Start date: January 2005
• Est. completion date: December 2008

Study information

• Verified date: November 2011
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• an integrated self-management education program
disease specific self-management program 'Living Well with COPD', developed in Montreal, Canada
• 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)
• care at initiative of the patient (usual GP care)
care at initiative of the patient (usual GP care)

Locations

Country	Name	City	State
Netherlands	Radboud University, Department of General Medicine	Nijmegen

Sponsors (5)

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

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

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

Outcome

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