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

NCT07320703

RecruitingNA

Sponsor: General Practitioners Research Institute

Conditions: Breathlessness, Cardiovascular, Pulmonary, Mental Disease

Interventions: Breathlessness diagnostics in a Box (BiaB)

Countries: Netherlands, Portugal, Spain

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (3)
  • Groningen, Netherlands
  • Porto, Portugal
  • Palma de Mallorca, Spain