Breathlessness Diagnostics in a Box for Primary Care
Official title: "Breathlessness Diagnostics in a Box" (BiaB) for Primary Care. A Multi-country Quality Improvement Project Using a Randomized Stepped-wedge Design
Run by General Practitioners Research Institute · NCT07320703 · Data updated 2026-11-12
This project will try whether giving primary care doctors a 'Breathlessness Diagnostics in a Box' toolkit helps adults with breathlessness get a diagnosis faster than usual care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 900 (estimated) |
| Sponsor | General Practitioners Research Institute Research network |
| Locations | 3 sites (Groningen and 2 other locations) |
| Status | Recruiting |
| Started | August 5, 2024 |
| Main results expected | April 2027 |
| Study ends | April 2027 |
| Registry record updated | January 7, 2026 |
| Trial ID | NCT07320703 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) who present to participating general practices with new, unexplained, or worsening breathlessness, or whose clinician feels additional tests are needed, are ideal candidates.
✕Probably not a fit
Patients experiencing an acute worsening of a clearly diagnosed chronic condition where no additional comorbidities are suspected, or people not seen at participating sites in the Netherlands, Spain, or Portugal, are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective stepped-wedge cluster project introduces a diagnostic toolkit (BiaB) across 45 general practice sites in the Netherlands, Spain, and Portugal, with sites switching from usual care to the intervention on a scheduled sequence. The main comparison is time to diagnosis for adults presenting with new or worsening breathlessness during the BiaB period versus the usual-care period, using routine clinical data, electronic medical records, and questionnaires from patients and clinicians. Secondary goals include whether BiaB increases new diagnoses of COPD and cardiovascular disease and whether clinicians find the toolkit usable and efficient. Each site participates for about 40 weeks and patients typically have one study visit and up to four quarterly questionnaires over a year.
Why it matters
Potential benefit: If successful, patients could receive faster, more accurate diagnoses of the causes of breathlessness, enabling earlier and more appropriate treatment.
How similar studies have gone: Related diagnostic pathway interventions in primary care have shown promise for improving diagnosis rates and timeliness, but the packaged BiaB intervention and its multicountry stepped-wedge rollout are relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
15 primary care sites across Portugal
Porto, Portugal Recruiting -
15 primary care sites across the Netherlands
Groningen, Netherlands Active not recruiting -
15 primary care sites across Palma De Mallorca, Madrid, Murcia
Palma de Mallorca, Spain Active not recruiting
Study contacts
- Study coordinator: Janwillem WH Kocks, Prof. Dr.
- Email: biab@gpri.nl
- Phone: +31502113898
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.