NCT07320703 "Breathlessness Diagnostics in a Box" (BiaB) for Primary Care. A Multi-country Quality Improvement Project Using a Randomized Stepped-wedge Design
| NCT ID | NCT07320703 |
| Status | Recruiting |
| Phase | — |
| Sponsor | General Practitioners Research Institute |
| Condition | Breathlessness |
| Study Type | INTERVENTIONAL |
| Enrollment | 900 participants |
| Start Date | 2024-08-05 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 900 participants in total. It began in 2024-08-05 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07320703 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breathlessness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07320703 currently recruiting?
Yes, NCT07320703 is actively recruiting participants. Contact the research team at biab@gpri.nl for enrollment information.
Where is the NCT07320703 trial being conducted?
This trial is being conducted at Groningen, Netherlands, Porto, Portugal, Palma de Mallorca, Spain.
Who is sponsoring the NCT07320703 clinical trial?
NCT07320703 is sponsored by General Practitioners Research Institute. The trial plans to enroll 900 participants.