Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07320703

"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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

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

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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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