Asthma Control in a Dutch Primary Care Population

NCT ID: NCT04456270

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 222 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2022-03-01

Brief Summary

Rationale: Despite the availability of effective treatment to reach symptom control, nearly half of the asthma patients remain inadequately controlled. There is a need for timely and appropriate treatment of patients with uncontrolled asthma. Improving asthma control could be achieved by a better identification of causes followed by remediating modifiable factors in primary care or referral to secondary care. However, major gaps in evidence-based asthma practice exist in primary care. So far, there is a lack of knowledge on the prevalence of inadequate asthma and associated characteristics.

Objective: The primary objective is to determine the proportion of primary care patients with inadequate asthma control, as assessed during a regular control consultation with the general practice nurse.

Study design: This is a non-interventional prospective observational study, taking place in a real-world primary care setting. The AsthmaOptimiser tool will be used during regular asthma consultations in primary care, which the healthcare provider will fill in together with the patient. The AsthmaOptimiser tool creates an overview of factors and characteristics that may be associated with uncontrolled asthma, and subsequently provides a guideline-based management suggestion. Additionally, we will perform qualitative interviews to collect experiences and perspectives of healthcare providers on their use of the AsthmaOptimiser tool, including, but not limited to, ease of use, points of improvement, and on their implementation of the management suggestions.

Study population: Patients diagnosed with asthma, who attend a pre-planned primary care asthma review, 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.

Main study parameters/endpoints: The primary endpoint is the proportion of patients with inadequate asthma control. Inadequate asthma control will be defined as an exacerbation in the past 4 weeks and/or an ACQ6 (i.e., Asthma Control Questionnaire) score >0.75.

Conditions

Asthma; Asthma; Eosinophilic; Asthma Chronic; Asthma; Status

Study Design

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

Study Groups

Primary care patients with current asthma

Male and female primary care patients aged ≥18 years of age with clinically diagnosed asthma.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Aged ≥ 18 years
• Physician diagnosis of Asthma
• Capacity to provide written informed consent

Exclusion Criteria

• Life expectancy of less than 1 year
• Inability to understand Dutch
• Any other condition which, at the GPs and/or investigator's discretion, is believed to present a safety risk or may impact the study results
• Patients participating in a clinical trial that may distort outcomes in this observational study.

• Minimum Eligible Age: 18 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

Principal Investigators

Janwillem Kocks, PhD

Role: PRINCIPAL_INVESTIGATOR

General Practitioners Research Institute

Locations

GPRI

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

GPRI19103

Identifier Type: -

Identifier Source: org_study_id