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

  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.

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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Page 1 of 1 (3 locations)

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