Costs and Effects of Three Modes for Disease Management of Chronic Obstructive Pulmonary Disease in General Practice - Full Text View

Purpose

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	Intervention
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)

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (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

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

U.S. FDA Resources

Further study details as provided by Radboud University:

Primary Outcome Measures:

disease-specific health-related quality of life (HRQoL) [ Time Frame: two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

the number of exacerbations [ Time Frame: two years ] [ Designated as safety issue: No ]
generic quality of life [ Time Frame: two years ] [ Designated as safety issue: No ]
decline post- and pre-bronchodilator (BD) lung function indices [ Time Frame: two years ] [ Designated as safety issue: No ]
level of respiratory symptoms [ Time Frame: two years ] [ Designated as safety issue: No ]
satisfaction with the health care received [ Time Frame: two years ] [ Designated as safety issue: No ]
compliance with (non-) pharmaceutical treatment [ Time Frame: two years ] [ Designated as safety issue: No ]
direct and indirect medical costs [ Time Frame: two years ] [ Designated as safety issue: No ]
COPD related self-efficacy [ Time Frame: two years ] [ Designated as safety issue: No ]
COPD coping styles [ Time Frame: two years ] [ Designated as safety issue: No ]

Enrollment:	165
Study Start Date:	January 2005
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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)
Experimental: self-management 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

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?

Eligibility

Ages Eligible for Study:	35 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00128765

Locations

Netherlands
Radboud University, Department of General Medicine
Nijmegen, Netherlands, 6500 HB

Sponsors and Collaborators

Radboud University

ZonMw: The Netherlands Organisation for Health Research and Development

PICASSO: Partners in Care Solutions for COPD

Erasmus Medical Center

McGill University

Investigators

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

More Information

Publications:

Bourbeau J, Julien M, Maltais F, Rouleau M, Beaupre A, Begin 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 Sante du Quebec. 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.

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.

Bourbeau J, Nault D, Dang-Tan T. Self-management and behaviour modification in COPD . Patient Educ Couns. 2004 Mar;52(3):271-7.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bischoff EW, Akkermans R, Bourbeau J, van Weel C, Vercoulen JH, Schermer TR. Comprehensive self management and routine monitoring in chronic obstructive pulmonary disease patients in general practice: randomised controlled trial. BMJ. 2012 Nov 28;345:e7642. doi: 10.1136/bmj.e7642.

Responsible Party:	E. Bischoff, MD MSc, Radboud University
ClinicalTrials.gov Identifier:	NCT00128765 History of Changes
Other Study ID Numbers:	MONC95582, ZonMw grant: 945.04.230, Picasso grant: 005.2004, CMO: 2004/249
Study First Received:	August 9, 2005
Last Updated:	November 21, 2011
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:

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

Additional relevant MeSH terms:

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013