"Breathlessness Diagnostics in a Box" (BiaB) for Primary Care. A Multi-country Quality Improvement Project Using a Randomized Stepped-wedge Design

Recruiting now · Not applicable

Conditions studied: Breathlessness, Cardiovascular, Pulmonary, Mental Disease

In brief

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.

Key facts

Study ID

NCT07320703

Run by

General Practitioners Research Institute

People needed

900

Starts

2024-08-05

Expected to finish

2027-04-01

Last updated by the study team

2026-01-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 15 primary care sites across Portugal — Porto, Portugal (enrolling)
• 15 primary care sites across the Netherlands — Groningen, Netherlands
• 15 primary care sites across Palma De Mallorca, Madrid, Murcia — Palma de Mallorca, Spain

Full record on ClinicalTrials.gov

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