The COPD Optimiser
- Conditions
- COPD
- Registration Number
- NCT06659666
- Lead Sponsor
- General Practitioners Research Institute
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 100
- Physician diagnosis of COPD (ICPC R95),
- Capacity to understand and provide written informed consent.
- Active diagnosis of Asthma (ICPC R96)
- Patients participating in an interventional clinical trial
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method patterns of co-occurrence of GOLD-guided management suggestions in a Dutch primary care population of patients with COPD. Immediately after the procedure The primary endpoint is the number of times that each management suggestion was given. With this endpoint, we can describe the proportion of primary care patients with COPD of whom disease management can be optimized per GOLD-guided management suggestions from the COPD Optimiser. Incidence will be described for each of the possible management suggestions from the COPD Optimiser.
- Secondary Outcome Measures
Name Time Method Co-occurance and concordance of GOLD-based management suggestions Immediately after the procedure The secondary study endpoints are
1. The presence of co-occurring GOLD-guided management suggestions from the COPD Optimiser in primary care patients with COPD
2. The proportion of patients for whom the current medication regimen is not in line with the GOLD pharmacological treatment recommendation, either:
1. The proportion of patients that received a GOLD-guided step-up advice from the COPD Optimiser
2. The proportion of patients that received a GOLD-guided step-down advice from the COPD optimiser
Trial Locations
- Locations (2)
General practices in Netherlands
🇳🇱Groningen, Netherlands
GPRI
🇳🇱Groningen, Netherlands
General practices in Netherlands🇳🇱Groningen, Netherlands