Actively Recruiting
"Breathlessness Diagnostics in a Box" (BiaB) for Primary Care. A Multi-country Quality Improvement Project Using a Randomized Stepped-wedge Design
Led by General Practitioners Research Institute · Updated on 2026-01-07
900
Participants Needed
3
Research Sites
138 weeks
Total Duration
On this page
Sponsors
G
General Practitioners Research Institute
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
"Breathlessness Diagnostics in a Box" (BiaB) for Primary Care. A Multi-country Quality Improvement Project Using a Randomized Stepped-wedge Design
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient must be at least 18 years old at the time of signing the informed consent.
- Patients who present with undiagnosed breathlessness (dyspnea).
- Patients with known diseases that could cause breathlessness but have residual or worsening breathlessness that may be due to other undetected causes.
- Patients for whom healthcare professionals require additional tests to confirm or suspect new or parallel diagnoses related to breathlessness.
- Patients assessed within frameworks like Cardiovascular Risk Management or COPD monitoring.
You will not qualify if you...
- Acute worsening of a previously diagnosed chronic disease without suspicion of additional comorbidities.
- Inability to understand and sign the written consent form.
AI-Screening
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Trial Site Locations
Total: 3 locations
1
15 primary care sites across the Netherlands
Groningen, Netherlands
Active, Not Recruiting
2
15 primary care sites across Portugal
Porto, Portugal
Actively Recruiting
3
15 primary care sites across Palma De Mallorca, Madrid, Murcia
Palma de Mallorca, Spain
Active, Not Recruiting
Research Team
J
Janwillem WH Kocks, Prof. Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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