Asthma Control in a Dutch Primary Care Population

NCT04456270 | Completed

• 1 other identifier: GPRI19103
• Study Type: observational
• Target: 222
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Asthma Control Questionnaire

  self-reported assessment of asthma symptoms

  week prior to visit to general practice nurse for check-up appointment

Study Arms (1)

Primary care patients with current asthma

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care patients with a current asthma diagnosis, who are scheduled to have in-person asthma review consultations with a primary care nurse, will be recruited from primary care practices located in the northern part of the Netherlands. The population includes men and women ≥18 years of age with clinically diagnosed asthma. The diagnosis of asthma is allowed to be a clinical diagnosis rendered by a doctor, without the requirement to conduct additional confirmatory testing. Furthermore, a limited number of in- and exclusion criteria will be adopted, to make sure the research population closely resembles the real world.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• General Practitioners Research Institute: lead
• AstraZeneca: collaborator

Study Sites (1)

GPRI

Groningen, Netherlands

Location

MeSH Terms

Conditions

Asthma; Pulmonary Eosinophilia

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Hypereosinophilic Syndrome; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Janwillem Kocks, PhD

  General Practitioners Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 2, 2020
• Study Start: October 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: March 1, 2022
• Last Updated: May 14, 2024

Record last verified: 2024-05

Locations

NL (1)