MedDataX Logo

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

NCT ID: NCT00128765

Last Updated: 2011-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2008-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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?

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Diseases, Obstructive

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

usual care

usual care, i.e. COPD care at patient's own initiative, mostly for medical help during exacerbations

Group Type ACTIVE_COMPARATOR

care at initiative of the patient (usual GP care)

Intervention Type BEHAVIORAL

care at initiative of the patient (usual GP care)

monitoring controls

regular COPD care (monitoring) provided by practice nurse according to current COPD guidelines

Group Type EXPERIMENTAL

regular practice nurse review (monitoring controls)

Intervention Type BEHAVIORAL

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

self-management

disease specific self-management program 'Living Well with COPD'

Group Type EXPERIMENTAL

an integrated self-management education program

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

an integrated self-management education program

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

Intervention Type 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)

Intervention Type BEHAVIORAL

care at initiative of the patient (usual GP care)

care at initiative of the patient (usual GP care)

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role collaborator

PICASSO: Partners in Care Solutions for COPD

OTHER

Sponsor Role collaborator

Erasmus Medical Center

OTHER

Sponsor Role collaborator

McGill University

OTHER

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

E. Bischoff

MD MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Chris van Weel, FRCP

Role: STUDY_CHAIR

Department of General Practice, Radboud University, Nijmegen, The Netherlands

Tjard Schermer, PhD

Role: STUDY_DIRECTOR

Department of General Practice, Radboud University, Nijmegen, The Netherlands

Erik Bischoff, MD

Role: PRINCIPAL_INVESTIGATOR

Department of General Practice, Radboud University, Nijmegen, The Netherlands

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Radboud University, Department of General Medicine

Nijmegen, , Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 12622605 (View on PubMed)

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. doi: 10.1136/thorax.58.5.394.

Reference Type BACKGROUND
PMID: 12728158 (View on PubMed)

Bourbeau 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.

Reference Type BACKGROUND
PMID: 14998597 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23190905 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ZonMw grant: 945.04.230

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Picasso grant: 005.2004

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CMO: 2004/249

Identifier Type: OTHER

Identifier Source: secondary_id

MONC95582

Identifier Type: -

Identifier Source: org_study_id