BreathlessnessBiaBNCT07320703
"Breathlessness Diagnostics in a Box" (BiaB) for Primary Care. A Multi-country Quality Improvement Project Using a Randomized Stepped-wedge Design
A study testing Breathlessness diagnostics in a Box (BiaB) in people with Breathlessness and Cardiovascular, run by General Practitioners Research Institute at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breathlessness, Cardiovascular, Pulmonary
- What is being tested?
- Breathlessness diagnostics in a Box (BiaB)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 5 Aug 2024to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
Netherlands1 site
- Active, not recruiting
15 primary care sites across the Netherlands
Groningen
Portugal1 site, 1 recruiting
- Recruiting
15 primary care sites across Portugal
Porto
GPRI, +31502113898, biab@gpri.nl
Spain1 site
- Active, not recruiting
15 primary care sites across Palma De Mallorca, Madrid, Murcia
Palma de Mallorca
About this study
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.
Read the 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 five predefined sequences determining the timing of transition from usual care to the BiaB intervention. All sites start in the usual care phase and sequentially transition to the intervention phase according to the study schedule.
The primary objective of the study is to assess whether use of BiaB shortens the time to diagnosis in patients presenting with breathlessness, compared with usual care without BiaB. Secondary objectives include evaluating whether BiaB increases the number of new diagnoses of chronic obstructive pulmonary disease (COPD) and cardiovascular disease (CVD), and assessing the usability and efficiency of the BiaB tool.
The study is conducted in general practice settings in the Netherlands, Spain, and Portugal, with a total of 45 sites. Each site participates for a total duration of 40 weeks. Patients attend a single study visit and may complete up to four quarterly questionnaires over a maximum follow-up of one year. Data are collected during routine clinical care, from electronic medical records, and via questionnaires completed by patients and healthcare professionals. Data from the usual care period, and where available retrospective data, are used as control data for comparison with the intervention period.
- Conditions
- Breathlessness, Cardiovascular, Pulmonary, Mental Disease
- Being tested
- Breathlessness diagnostics in a Box (BiaB)
- Keywords
- breathlessness, diagnostics, cardiovascular disease, pulmonary disease, mental disease, cardiopulmonary risk
- Medical subject headings
- Dyspnea, Mental Disorders, Cardiovascular Diseases, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathlessness diagnostics in a Box (BiaB)Diagnostic test
The Breathlessness diagnostics in a Box (BiaB) is a diagnostic support tool used in general practice to assist healthcare professionals in the assessment of patients presenting with breathlessness as part of routine clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Patients are managed according to usual care for the assessment of breathlessness in general practice, without use of the Breathlessness diagnostics in a Box (BiaB) tool. Clinical assessments, diagnostic procedures, and follow-up are performed as part of routine practice. Data collected during this period are used as control data for comparison with the intervention period. |
| BiaB Intervention | Experimental | Patients are managed using the Breathlessness diagnostics in a Box (BiaB) tool as part of routine clinical care. The BiaB intervention supports general practitioners in the diagnostic assessment of patients presenting with breathlessness. No study-mandated therapeutic interventions are applied. Outcomes during the intervention period are compared with those from the usual care period. Receives: Diagnostic Test: Breathlessness diagnostics in a Box (BiaB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to diagnosis of the cause of breathlessness
Number of days between the first presentation or consultation for breathlessness and the date of diagnosis of the underlying cause of breathlessness, comparing periods of usual care and periods with use of the Breathlessness diagnostics in a Box (BiaB) intervention.
Measured: From first presentation or consultation for breathlessness up to the date of diagnosis, assessed during the study period (up to 40 weeks per site).
Secondary outcomes (2)
Number of new diagnoses of COPD and cardiovascular disease
Number of newly diagnosed cases of chronic obstructive pulmonary disease (COPD) and cardiovascular disease (CVD) identified during periods of usual care compared with periods with use of the Breathlessness diagnostics in a Box (BiaB) intervention.
Measured: Assessed during the study period (up to 40 weeks per site).
Usability and efficiency of the BiaB tool
Usability and efficiency of the Breathlessness diagnostics in a Box (BiaB) tool as assessed by questionnaires completed by healthcare professionals and patients during the intervention period.
Measured: During the intervention period, with follow-up questionnaires completed up to 12 months after the index visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start5 Aug 2024
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreathlessnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- A prospective stepped-wedge study design will be used for this study. In every country, participating sites will be assigned to one of the five sequences (3 sites per sequence) for timing of the intervention start. Each sequence starts with a usual care period (6 weeks or a multiple of 6) which will be followed by a transition period of 4 weeks prior to the BiaB intervention period (6 weeks or a multiple of 6). During the transition period the healthcare professionals (HCPs) at the site will be instructed about the start date of the BiaB intervention and they will receive training for the use of BiaB. The study duration for sites is 40 weeks in total. The maximum study duration for patients is one visit followed by a maximum of 4 quarterly questionnaires (1 year).
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Practitioners Research Institute
- Sponsor type
- Research network
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07320703
- Sponsor's protocol ID
- GPRI-2024-001
- Other IDs
- EUPAS1000000217
- Acronym
- BiaB
- Status last verified
- Jan 2026
- First submitted
- 22 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Breathlessness Diagnostics in a Box" (BiaB) for Primary Care. A Multi-country Quality Improvement Project Using a Randomized Stepped-wedge Design
- ClinicalTrials.gov ID
- NCT07320703
- Acronym / sponsor ID
- BiaB / GPRI-2024-001
- Conditions
- Breathlessness, Cardiovascular, Pulmonary, Mental Disease
- Keywords
- breathlessness, diagnostics, cardiovascular disease, pulmonary disease, mental disease, cardiopulmonary risk
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- General Practitioners Research InstituteResearch network
- Collaborators
- AstraZeneca
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 five predefined sequences determining the timing of transition from usual care to the BiaB intervention. All sites start in the usual care phase and sequentially transition to the intervention phase according to the study schedule.
The primary objective of the study is to assess whether use of BiaB shortens the time to diagnosis in patients presenting with breathlessness, compared with usual care without BiaB. Secondary objectives include evaluating whether BiaB increases the number of new diagnoses of chronic obstructive pulmonary disease (COPD) and cardiovascular disease (CVD), and assessing the usability and efficiency of the BiaB tool.
The study is conducted in general practice settings in the Netherlands, Spain, and Portugal, with a total of 45 sites. Each site participates for a total duration of 40 weeks. Patients attend a single study visit and may complete up to four quarterly questionnaires over a maximum follow-up of one year. Data are collected during routine clinical care, from electronic medical records, and via questionnaires completed by patients and healthcare professionals. Data from the usual care period, and where available retrospective data, are used as control data for comparison with the intervention period.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective stepped-wedge study design will be used for this study. In every country, participating sites will be assigned to one of the five sequences (3 sites per sequence) for timing of the intervention start. Each sequence starts with a usual care period (6 weeks or a multiple of 6) which will be followed by a transition period of 4 weeks prior to the BiaB intervention period (6 weeks or a multiple of 6). During the transition period the healthcare professionals (HCPs) at the site will be instructed about the start date of the BiaB intervention and they will receive training for the use of BiaB. The study duration for sites is 40 weeks in total. The maximum study duration for patients is one visit followed by a maximum of 4 quarterly questionnaires (1 year).
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Patients are managed according to usual care for the assessment of breathlessness in general practice, without use of the Breathlessness diagnostics in a Box (BiaB) tool. Clinical assessments, diagnostic procedures, and follow-up are performed as part of routine practice. Data collected during this period are used as control data for comparison with the intervention period. |
| BiaB Intervention | Experimental | Diagnostic Test: Breathlessness diagnostics in a Box (BiaB)Patients are managed using the Breathlessness diagnostics in a Box (BiaB) tool as part of routine clinical care. The BiaB intervention supports general practitioners in the diagnostic assessment of patients presenting with breathlessness. No study-mandated therapeutic interventions are applied. Outcomes during the intervention period are compared with those from the usual care period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathlessness diagnostics in a Box (BiaB)The Breathlessness diagnostics in a Box (BiaB) is a diagnostic support tool used in general practice to assist healthcare professionals in the assessment of patients presenting with breathlessness as part of routine clinical care. | Diagnostic test | BiaB Intervention |
Primary outcome
Time to diagnosis of the cause of breathlessness
Time frame: From first presentation or consultation for breathlessness up to the date of diagnosis, assessed during the study period (up to 40 weeks per site).
Number of days between the first presentation or consultation for breathlessness and the date of diagnosis of the underlying cause of breathlessness, comparing periods of usual care and periods with use of the Breathlessness diagnostics in a Box (BiaB) intervention.
2 secondary outcomes
Number of new diagnoses of COPD and cardiovascular disease
Time frame: Assessed during the study period (up to 40 weeks per site).
Usability and efficiency of the BiaB tool
Time frame: During the intervention period, with follow-up questionnaires completed up to 12 months after the index visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathlessness diagnostics in a Box (BiaB) in people with Breathlessness and Cardiovascular, run by General Practitioners Research Institute at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands, Portugal, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janwillem WH Kocks, Prof. Dr. (+31502113898, biab@gpri.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to diagnosis of the cause of breathlessness (time frame: From first presentation or consultation for breathlessness up to the date of diagnosis, assessed during the study period (up to 40 weeks per site).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.