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

NCT07320703 | Recruiting

• 2 other identifiers: GPRI-2024-001EUPAS1000000217
• Study Type: interventional
• Target: 900
• Locations: 3 countries
• Sites: 3

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.

Conditions

Breathlessness; Cardiovascular; Pulmonary; Mental Disease

Keywords

breathlessness; diagnostics; cardiovascular disease; pulmonary disease; mental disease; cardiopulmonary risk

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Assessed during the study period (up to 40 weeks per site).

• Usability and efficiency of the BiaB tool

  During the intervention period, with follow-up questionnaires completed up to 12 months after the index visit.

Study Arms (2)

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.

Diagnostic Test: Breathlessness diagnostics in a Box (BiaB)

Interventions

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.

BiaB Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not 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
• 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.

Sponsors & Collaborators

• AstraZeneca: collaborator
• General Practitioners Research Institute: lead

Study Sites (3)

15 primary care sites across the Netherlands

Groningen, Netherlands

ACTIVE NOT RECRUITING

15 primary care sites across Portugal

Porto, Portugal

RECRUITING

15 primary care sites across Palma De Mallorca, Madrid, Murcia

Palma de Mallorca, Spain

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Dyspnea; Mental Disorders; Cardiovascular Diseases; Lung Diseases

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Janwillem WH Kocks, Prof. Dr.

CONTACT

+31502113898; biab@gpri.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 6, 2026
• Study Start: August 5, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); ES (1); PT (1)