Lung Diseases, ObstructiveNCT00128765
Costs and Effects of Three Modes for Disease Management of Chronic Obstructive Pulmonary Disease in General Practice
A study testing an integrated self-management education program and care at initiative of the patient (usual GP care) in people with Lung Diseases, Obstructive, run by Radboud University Medical Center at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Lung Diseases, Obstructive
- What is being tested?
- an integrated self-management education program and care at initiative of the patient (usual GP care)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2005to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University, Department of General Medicine
Nijmegen, 6500 HB
About this study
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
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.
Read the 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?
- Conditions
- Lung Diseases, Obstructive
- Being tested
- an integrated self-management education program, regular practice nurse review (monitoring controls), care at initiative of the patient (usual GP care)
- Keywords
- chronic obstructive pulmonary disease (COPD), self-management, practice nurse, cost-effectiveness, randomized controlled trial
- Medical subject headings
- Lung Diseases, Obstructive, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
an integrated self-management education programBehavioural
disease specific self-management program 'Living Well with COPD', developed in Montreal, Canada
regular practice nurse review (monitoring controls)Behavioural
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)Behavioural
care at initiative of the patient (usual GP care)
| Study group | Role | What they receive |
|---|---|---|
| usual care | Active comparator | usual care, i.e. COPD care at patient's own initiative, mostly for medical help during exacerbations Receives: Behavioral: care at initiative of the patient (usual GP care) |
| monitoring controls | Experimental | regular COPD care (monitoring) provided by practice nurse according to current COPD guidelines Receives: Behavioral: regular practice nurse review (monitoring controls) |
| self-management | Experimental | disease specific self-management program 'Living Well with COPD' Receives: Behavioral: an integrated self-management education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-specific health-related quality of life (HRQoL)
Measured: two years
Secondary outcomes (9)
the number of exacerbations
Measured: two years
generic quality of life
Measured: two years
decline post- and pre-bronchodilator (BD) lung function indices
Measured: two years
level of respiratory symptoms
Measured: two years
satisfaction with the health care received
Measured: two years
compliance with (non-) pharmaceutical treatment
Measured: two years
direct and indirect medical costs
Measured: two years
COPD related self-efficacy
Measured: two years
COPD coping styles
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2005 (estimated)
- Study startJan 2005
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lung Diseases, ObstructiveStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, PICASSO: Partners in Care Solutions for COPD, Erasmus Medical Center, McGill University
- Responsible party
- Principal investigator, E. Bischoff, Radboud University Medical Center
- Investigators
- Chris van Weel, FRCP, Study chair, Department of General Practice, Radboud University, Nijmegen, The NetherlandsTjard Schermer, PhD, Study director, Department of General Practice, Radboud University, Nijmegen, The NetherlandsErik Bischoff, MD, Principal investigator, Department of General Practice, Radboud University, Nijmegen, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00128765
- Sponsor's protocol ID
- MONC95582
- Other IDs
- ZonMw grant: 945.04.230, Picasso grant: 005.2004, CMO: 2004/249
- Status last verified
- Nov 2011
- First submitted
- 9 Aug 2005
- Last updated
- 22 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1001/archinte.163.5.585.
PubMed 12622605Monninkhof 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.
PubMed 12728158Bourbeau 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.
PubMed 14998597Bischoff 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.
PubMed 23190905
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00128765
- Acronym / sponsor ID
- MONC95582
- Conditions
- Lung Diseases, Obstructive
- Keywords
- chronic obstructive pulmonary disease (COPD), self-management, practice nurse, cost-effectiveness, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, PICASSO: Partners in Care Solutions for COPD, Erasmus Medical Center, McGill University
- Study start
- Jan 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 10 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| usual care | Active comparator | Behavioral: care at initiative of the patient (usual GP care)usual care, i.e. COPD care at patient's own initiative, mostly for medical help during exacerbations |
| monitoring controls | Experimental | Behavioral: regular practice nurse review (monitoring controls)regular COPD care (monitoring) provided by practice nurse according to current COPD guidelines |
| self-management | Experimental | Behavioral: an integrated self-management education programdisease specific self-management program 'Living Well with COPD' |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| an integrated self-management education programdisease specific self-management program 'Living Well with COPD', developed in Montreal, Canada | Behavioural | self-management |
| 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) | Behavioural | monitoring controls |
| care at initiative of the patient (usual GP care)care at initiative of the patient (usual GP care) | Behavioural | usual care |
Primary outcome
disease-specific health-related quality of life (HRQoL)
Time frame: two years
9 secondary outcomes
the number of exacerbations
Time frame: two years
generic quality of life
Time frame: two years
decline post- and pre-bronchodilator (BD) lung function indices
Time frame: two years
level of respiratory symptoms
Time frame: two years
satisfaction with the health care received
Time frame: two years
compliance with (non-) pharmaceutical treatment
Time frame: two years
direct and indirect medical costs
Time frame: two years
COPD related self-efficacy
Time frame: two years
COPD coping styles
Time frame: two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2011.
- Background: PubMed 12622605Bourbeau 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.
- Background: PubMed 12728158Monninkhof 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.
- Background: PubMed 14998597Bourbeau 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.
- Derived from this study: PubMed 23190905Bischoff 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris van Weel, FRCP study chair
Department of General Practice, Radboud University, Nijmegen, The Netherlands
Tjard Schermer, PhD study director
Department of General Practice, Radboud University, Nijmegen, The Netherlands
Erik Bischoff, MD principal investigator
Department of General Practice, Radboud University, Nijmegen, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing an integrated self-management education program and care at initiative of the patient (usual GP care) in people with Lung Diseases, Obstructive, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease-specific health-related quality of life (HRQoL) (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00128765, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2011.