Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2025-12-24 @ 4:07 PM
Study NCT ID:
NCT06659666
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-10-26
First Post:
2024-10-22
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The COPD Optimiser
Sponsor:
General Practitioners Research Institute
Organization:
Study Overview
Official Title:
Opportunities to Optimize COPD Management Using the COPD Optimiser Online Tool in Dutch General Practice
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
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:
None
Brief Summary:
Rationale: The Global Initiative for Chronic Obstructive Lung Disease (GOLD) report pro- vides clinical treatment guidelines for COPD aimed at relieving and reducing the impact of symptoms, and reducing the risk of adverse health events, such as exacerbations. Despite the availability of these COPD treatment guidelines, evidence suggests that available thera- pies may not be utilized to their full potential to optimize disease management and outcomes for patients. So far, there is a lack of knowledge on the optimalisation opportunities of patients with COPD in a primary care setting.
Objective: The primary objective is to describe the GOLD-guided management suggestions obtained from the COPD Optimiser, in order to gain insight into optimalisation opportunities in a Dutch primary care population of patients with COPD.
Study design: This is a non-interventional prospective observational study, taking place in a real-world primary care setting.
Study population: Patients diagnosed with COPD are eligible to participate. A limited number of in- and exclusion criteria will be adopted, to make sure the research population closely resembles the real world.
ature and extent of the burden and risks associated with participation, benefit and group relatedness: Study specific involvement is limited to the one visit for the participant. Participants will receive enhanced usual medical care as determined by their physician and will not be randomly allocated to an experimental intervention or care as usual. The partici- pating general practices and participants in the study will be reimbursed for the time spent on this study. Risks of participating in the study are deemed to be negligible. All participants will use their own medication and follow the management plan that is in line with guidelines. The study specific additions to the consultation are administering a (not emotionally demanding) questionnaire and drawing a small amount of blood from the finger, to measure the level of blood eosinophils, using a point-of-care method. This is a test that may cause a slight incon- venience for the patient, although this test is less invasive than typical blood draws that would be part of the newest international guideline.
Primary objective
1\. Describe the GOLD-guided management suggestions obtained from the COPD Optimiser, in order to gain insight into optimalisation opportunities in a Dutch primary care pop- ulation of patients with COPD. The endpoint for the primary objective is the number of times that each manage- ment suggestion was given
Objective: The primary objective is to describe the GOLD-guided management suggestions obtained from the COPD Optimiser, in order to gain insight into optimalisation opportunities in a Dutch primary care population of patients with COPD.
Study design: This is a non-interventional prospective observational study, taking place in a real-world primary care setting.
Study population: Patients diagnosed with COPD are eligible to participate. A limited number of in- and exclusion criteria will be adopted, to make sure the research population closely resembles the real world.
ature and extent of the burden and risks associated with participation, benefit and group relatedness: Study specific involvement is limited to the one visit for the participant. Participants will receive enhanced usual medical care as determined by their physician and will not be randomly allocated to an experimental intervention or care as usual. The partici- pating general practices and participants in the study will be reimbursed for the time spent on this study. Risks of participating in the study are deemed to be negligible. All participants will use their own medication and follow the management plan that is in line with guidelines. The study specific additions to the consultation are administering a (not emotionally demanding) questionnaire and drawing a small amount of blood from the finger, to measure the level of blood eosinophils, using a point-of-care method. This is a test that may cause a slight incon- venience for the patient, although this test is less invasive than typical blood draws that would be part of the newest international guideline.
Primary objective
1\. Describe the GOLD-guided management suggestions obtained from the COPD Optimiser, in order to gain insight into optimalisation opportunities in a Dutch primary care pop- ulation of patients with COPD. The endpoint for the primary objective is the number of times that each manage- ment suggestion was given
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: