Predicting the Course of Chronic Obstructive Pulmonary Disease (COPD) in Primary Care

NCT ID: NCT00706602

Last Updated: 2010-06-28

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 450 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2014-08-31

Brief Summary

Background: COPD is a systemic illness; morbidity and mortality due to this disease are on the increase, and it has great impact on patients' lives. Most COPD patients are managed by general practitioners (GP). GPs base their initial assessment of patients' disease severity mainly on lung function and then inform patients about adequate treatment. However, lung function correlates poorly with COPD-specific health-related quality of life and exacerbation frequency. Preventive cardiology embraced risk index-guided treatment successfully. COPD disease severity indices that better represent the clinical manifestations of COPD are needed that can be used to guide risk-stratified treatment.

Objectives: (1) The development and validation of a practical COPD disease severity index to predict the course of health-related quality of life over time. (2) The validation of the ADO-Index (Age, Dyspnea, Obstruction) to predict 3-year mortality in COPD patients in primary care. (3) Link evidence on treatment effects to the COPD risk indices to guide COPD treatment selection.

Methods: We are in the process of conducting two linked prospective cohort studies with 413 COPD patients (GOLD stages 2-4) from GPs in Switzerland and the Netherlands. We performed a sound baseline assessment including detailed patient history, lung function, measurement of exercise capacity and blood sampling. During the follow-up of at least five years, we update the patients' profile by registering health status, exacerbations and health-related quality of life and, after 2 years, lung function and measurement of exercise capacity. For aim 1, we will identify the best combination of variables predicting the course of health-related quality of life over time using multivariable regression analysis. For aim 2, we will assess discrimination and calibration of the ADO index to predict 3-year mortality. For aim 3, we will estimate treatment effects for individual patient profiles using complex statistical models such as Markov models.

Significance of project: After this study, different risk scores will be available for use in primary care so that general practitioners can estimate what impact COPD will have on the patients. By linking these risk scores to evidence form treatment studies, it will be possible to show for an individual patient how COPD and different treatments impacts on mortality, symptoms and exacerbations. Thereby, patients and physicians can make more informed treatment decisions balancing the benefits and downsides of different treatments.

Conditions

COPD

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1

Swiss COPD cohort

No interventions assigned to this group

2

Dutch COPD cohort

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients ≥40 years of age with COPD in GOLD stage II to IV (postbronchodilator FEV1/FVC≤0.70, postbronchodilator FEV1≤80% predicted) are eligible if in- or outpatient treatment of their last exacerbation ended ≥4 weeks ago.

Exclusion Criteria

• Patients who received mechanical ventilation in the previous 12 months (because of extremely poor prognosis), patients with co-morbidities associated with a life expectancy of ≤12 months, patients diagnosed with dementia, psychosis or other psychiatric illness that invalidate assessment of patient-reported parameters and patients who cannot complete thr baseline assessment due to language difficulties.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swiss National Science Foundation

OTHER

Sponsor Role: collaborator

Zurich Lung League

OTHER

Sponsor Role: collaborator

The Netherlands Asthma Foundation

OTHER

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

University of Zurich and Johns Hopkins University

Principal Investigators

Milo A Puhan, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Zurich, Switzerland

Locations

Institute for primary care, University of Zurich

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

References

Siebeling L, ter Riet G, van der Wal WM, Geskus RB, Zoller M, Muggensturm P, Joleska I, Puhan MA. ICE COLD ERIC--International collaborative effort on chronic obstructive lung disease: exacerbation risk index cohorts--study protocol for an international COPD cohort study. BMC Pulm Med. 2009 May 6;9:15. doi: 10.1186/1471-2466-9-15.

Reference Type: BACKGROUND

PMID: 19419546 (View on PubMed)

Tai AS, Liao LH, Lin SH. On the Conventional Definition of Path-specific Effects: Fully Mediated Interaction With Multiple Ordered Mediators. Epidemiology. 2022 Nov 1;33(6):817-827. doi: 10.1097/EDE.0000000000001520. Epub 2022 Jun 24.

Reference Type: DERIVED

PMID: 36220579 (View on PubMed)

Steurer-Stey C, Dalla Lana K, Braun J, Ter Riet G, Puhan MA. Effects of the "Living well with COPD" intervention in primary care: a comparative study. Eur Respir J. 2018 Jan 4;51(1):1701375. doi: 10.1183/13993003.01375-2017. Print 2018 Jan.

Reference Type: DERIVED

PMID: 29301921 (View on PubMed)

Strassmann A, Frei A, Haile SR, Ter Riet G, Puhan MA. Commonly Used Patient-Reported Outcomes Do Not Improve Prediction of COPD Exacerbations: A Multicenter 4(1/2) Year Prospective Cohort Study. Chest. 2017 Dec;152(6):1179-1187. doi: 10.1016/j.chest.2017.09.003. Epub 2017 Sep 18.

Reference Type: DERIVED

PMID: 28923760 (View on PubMed)

Crook S, Frei A, Ter Riet G, Puhan MA. Prediction of long-term clinical outcomes using simple functional exercise performance tests in patients with COPD: a 5-year prospective cohort study. Respir Res. 2017 Jun 2;18(1):112. doi: 10.1186/s12931-017-0598-6.

Reference Type: DERIVED

PMID: 28578705 (View on PubMed)

Frei A, Siebeling L, Wolters C, Held L, Muggensturm P, Strassmann A, Zoller M, Ter Riet G, Puhan MA. The Inaccuracy of Patient Recall for COPD Exacerbation Rate Estimation and Its Implications: Results from Central Adjudication. Chest. 2016 Oct;150(4):860-868. doi: 10.1016/j.chest.2016.06.031. Epub 2016 Aug 26.

Reference Type: DERIVED

PMID: 27400907 (View on PubMed)

Frei A, Muggensturm P, Putcha N, Siebeling L, Zoller M, Boyd CM, ter Riet G, Puhan MA. Five comorbidities reflected the health status in patients with chronic obstructive pulmonary disease: the newly developed COMCOLD index. J Clin Epidemiol. 2014 Aug;67(8):904-11. doi: 10.1016/j.jclinepi.2014.03.005. Epub 2014 Apr 29.

Reference Type: DERIVED

PMID: 24786594 (View on PubMed)

Puhan MA, Siebeling L, Frei A, Zoller M, Bischoff-Ferrari H, Ter Riet G. No association of 25-hydroxyvitamin D with exacerbations in primary care patients with COPD. Chest. 2014 Jan;145(1):37-43. doi: 10.1378/chest.13-1296.

Reference Type: DERIVED

PMID: 24008868 (View on PubMed)

Puhan MA, Siebeling L, Zoller M, Muggensturm P, ter Riet G. Simple functional performance tests and mortality in COPD. Eur Respir J. 2013 Oct;42(4):956-63. doi: 10.1183/09031936.00131612. Epub 2013 Mar 21.

Reference Type: DERIVED

PMID: 23520321 (View on PubMed)

Other Identifiers

3.4.07.045

Identifier Type: -

Identifier Source: secondary_id

3233B0-115216

Identifier Type: -

Identifier Source: org_study_id