Ignite Creation Date:
2024-05-05 @ 7:36 PM
Last Modification Date:
2024-10-26 @ 9:51 AM
Study NCT ID:
NCT00706602
Status:
UNKNOWN
Last Update Posted:
2010-06-28
First Post:
2008-06-25
Brief Title:
Predicting the Course of Chronic Obstructive Pulmonary Disease COPD in Primary Care
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
International Collaborative Effort on Chronic Obstructive Lung Disease Exacerbation Risk Index Cohorts
Status:
UNKNOWN
Status Verified Date:
2010-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ICECOLDERIC
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 3407045 | None | None | None |