The COPD Optimiser

NCT ID: NCT06659666

Last Updated: 2025-12-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-09
• Study Completion Date: 2025-07-24

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

Conditions

COPD

Study Design

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

Study Groups

Usual care COPD consultation with the COPD Optimiser

Primary care patients with a current COPD diagnosis who visit the GP team for their COPD are eligible to participate in the study. Patients with COPD will be recruited from 10-15 primary care practices in the Netherlands. The population includes men and women ≥35 years of age with clinically diagnosed COPD. The diagnosis of COPD is allowed to be a clinical diagnosis rendered by a member of the GP team, without the requirement to conduct additional confirm- atory testing. Furthermore, a limited number of in- and exclusion criteria will be adopted, to make sure the research population closely resembles the real world.

COPD Optimiser

Intervention Type: DEVICE

Patients will receive enhanced usual medical care as determined by their physician. The study visit is a standard consultation supported by the COPD Optimiser webtool. The extra elements added to the COPD consultation are the use of the COPD Optimiser and a short questionnaire directly following the consultation on the patient's experience with the COPD Optimiser. Patients can additionally consent to two optional elements: 1) a determination of blood eosinophil count using a point of care test and 2) a brief interview on their experience with the COPD Optimiser. this tool creates an overview of fac- tors and characteristics that may be associated with suboptimal COPD and provides GOLD guideline-based management suggestions. Implementation of the COPD Optimiser will sup- port healthcare professionals in providing optimal care for their COPD patients by providing individualized GOLD-guided management suggestions.

Interventions

COPD Optimiser

Patients will receive enhanced usual medical care as determined by their physician. The study visit is a standard consultation supported by the COPD Optimiser webtool. The extra elements added to the COPD consultation are the use of the COPD Optimiser and a short questionnaire directly following the consultation on the patient's experience with the COPD Optimiser. Patients can additionally consent to two optional elements: 1) a determination of blood eosinophil count using a point of care test and 2) a brief interview on their experience with the COPD Optimiser. this tool creates an overview of fac- tors and characteristics that may be associated with suboptimal COPD and provides GOLD guideline-based management suggestions. Implementation of the COPD Optimiser will sup- port healthcare professionals in providing optimal care for their COPD patients by providing individualized GOLD-guided management suggestions.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Physician diagnosis of COPD (ICPC R95),
• Capacity to understand and provide written informed consent.

Exclusion Criteria

• Active diagnosis of Asthma (ICPC R96)
• Patients participating in an interventional clinical trial

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

General Practitioners Research Institute

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

General practices in Netherlands

Groningen, Provincie Groningen, Netherlands

GPRI

Groningen, Provincie Groningen, Netherlands

Countries

Netherlands

Related Links

https://goldcopd.org/2024-gold-report/

2024 GOLD Report - Global Initiative for Chronic Obstructive Lung Disease - GOLD. Ac- cessed July 19, 2024. https://goldcopd.org/2024-gold-report/

Other Identifiers

GPRI_2024_003

Identifier Type: -

Identifier Source: org_study_id