Costs and Effects of Three Modes for Disease Management of Chronic Obstructive Pulmonary Disease in General Practice
4 other identifiers
interventional
165
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2005
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 9, 2005
CompletedFirst Posted
Study publicly available on registry
August 10, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedNovember 22, 2011
November 1, 2011
3.9 years
August 9, 2005
November 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
disease-specific health-related quality of life (HRQoL)
two years
Secondary Outcomes (9)
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
- +4 more secondary outcomes
Study Arms (3)
usual care
ACTIVE COMPARATORusual care, i.e. COPD care at patient's own initiative, mostly for medical help during exacerbations
monitoring controls
EXPERIMENTALregular COPD care (monitoring) provided by practice nurse according to current COPD guidelines
self-management
EXPERIMENTALdisease specific self-management program 'Living Well with COPD'
Interventions
disease specific self-management program 'Living Well with COPD', developed in Montreal, Canada
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Radboud University Medical Centerlead
- ZonMw: The Netherlands Organisation for Health Research and Developmentcollaborator
- PICASSO: Partners in Care Solutions for COPDcollaborator
- Erasmus Medical Centercollaborator
- McGill Universitycollaborator
Study Sites (1)
Radboud University, Department of General Medicine
Nijmegen, 6500 HB, Netherlands
Related Publications (4)
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. doi: 10.1001/archinte.163.5.585.
PMID: 12622605BACKGROUNDMonninkhof 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. doi: 10.1136/thorax.58.5.394.
PMID: 12728158BACKGROUNDBourbeau J, Nault D, Dang-Tan T. Self-management and behaviour modification in COPD. Patient Educ Couns. 2004 Mar;52(3):271-7. doi: 10.1016/S0738-3991(03)00102-2.
PMID: 14998597BACKGROUNDBischoff 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.
PMID: 23190905DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD MSc
Study Record Dates
First Submitted
August 9, 2005
First Posted
August 10, 2005
Study Start
January 1, 2005
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
November 22, 2011
Record last verified: 2011-11