Breathlessness diagnostics in a Box (BiaB): The Breathlessness diagnostics in a Box (BiaB) is a diagnostic support tool used in general practice to assist healthcare professionals in the assessment of patients presenting with breathlessness as part of routine clinical care.
Study summary
This prospective stepped-wedge study evaluates whether use of the Breathlessness diagnostics in a Box (BiaB) tool shortens the time to diagnosis in patients presenting with breathlessness, compared with usual care. The study is conducted in general practice settings in the Netherlands, Spain, and Portugal. Participating sites start with a usual care period and transition sequentially to the BiaB intervention period. Data are collected during routine clinical visits, from electronic medical records, and through questionnaires completed by patients and healthcare professionals.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
The study aims to capture the real-world heterogeneity in primary care practices and patients. Therefore, inclusion and exclusion criteria are limited.
Inclusion criteria
* Patient must be at least 18 years old at the time of signing the informed consent.
* Patients that present with undiagnosed dyspnea (breathlessness); or Patients who have existing diseases that could cause breathlessness, but have residual or increasing breathlessness that could be caused by other not yet detected diseases. Or HCP has doubts or requires additional tests to confirm diagnosis or to suspect new, parallel, diagnoses. For example, breathlessness in patients assessed within the framework of Cardiovascular Risk Management or for COPD monitoring
Exclusion criteria
1. Acute worsening of previous diagnosed chronic disease where there is no suspicion of comorbidities (for example when a patient with clear COPD diagnosis has an exacerbation where typically the HCP will not perform additional tests).
2. Inability to understand and sign the written consent form.
Primary outcome measure(s)
Time to diagnosis of the cause of breathlessness — From first presentation or consultation for breathlessness up to the date of diagnosis, assessed during the study period (up to 40 weeks per site). Number of days between the first presentation or consultation for breathlessness and the date of diagnosis of the underlying cause of breathlessness, comparing periods of usual care and periods with use of the Breathlessness diagnostics in a Box (BiaB) intervention.
Trial sites (3)
Facility
City
Region
Status
15 primary care sites across the Netherlands
Groningen
Netherlands
Active Not Recruiting
15 primary care sites across Portugal
Porto
Portugal
Recruiting
15 primary care sites across Palma De Mallorca, Madrid, Murcia
Palma de Mallorca
Spain
Active Not Recruiting
More General Practitioners Research Institute trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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