Status:
RECRUITING
"Breathlessness Diagnostics in a Box" (BiaB) for Primary Care. A Multi-country Quality Improvement Project Using a Randomized Stepped-wedge Design
Lead Sponsor:
General Practitioners Research Institute
Collaborating Sponsors:
AstraZeneca
Conditions:
Breathlessness
Cardiovascular
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 wi...
Detailed Description
This is a prospective interventional study using a stepped-wedge cluster design with a usual care period followed by an intervention period. Participating general practice sites are assigned to one of...
Eligibility 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
- 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).
- Inability to understand and sign the written consent form.
Key Trial Info
Start Date :
August 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT07320703
Start Date
August 5 2024
End Date
April 1 2027
Last Update
January 7 2026
Active Locations (3)
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1
15 primary care sites across the Netherlands
Groningen, Netherlands
2
15 primary care sites across Portugal
Porto, Portugal
3
15 primary care sites across Palma De Mallorca, Madrid, Murcia
Palma de Mallorca, Spain