Asthma Control in a Dutch Primary Care Population

Asthma Clinical Trial

Official title:

Asthma Control in a Dutch Primary Care Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04456270
• Other study ID #: GPRI19103
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: May 2024
• Source: General Practitioners Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: March 1, 2022
• Est. primary completion date: December 1, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Asthma Chronic
• Asthma; Eosinophilic
• Asthma; Status
• Pulmonary Eosinophilia

Locations

Country	Name	City	State
Netherlands	GPRI	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
General Practitioners Research Institute	AstraZeneca

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma Control Questionnaire	self-reported assessment of asthma symptoms	week prior to visit to general practice nurse for check-up appointment