Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000217

EU PAS number

EUPAS1000000217

Study ID

1000000217

Official title and acronym

"Breathlessness diagnostics in a Box" for primary care. A multi-country quality improvement project using a stepped-wedge design. "Breathlessness diagnostics in a Box" (BiaB)

DARWIN EU® study

No

Study countries

Netherlands
Spain
United Kingdom

Study description

Breathlessness has a prevalence of ~10% and is a common reason for people to consult their general practitioner. As breathlessness is a symptom in various conditions it is difficult to determine its cause, which hampers optimal treatment. There is a lack of quick and easy tests that can be used in primary care to diagnose the cause of breathlessness. Therefore, we have developed "Breathlessness diagnostics in a Box" (BiaB), an easy and reliable tool intended to support healthcare professionals with fast execution of diagnostic procedures required to diagnose the cause(s) of breathlessness. In 2023 a pilot study was performed to design and test BiaB. In the current study, we aim to investigate whether implementation of BiaB in primary care will shorten the time for the diagnostic process for patients presenting with breathlessness.

Study status

Planned
Research institutions and networks

Institutions

Contact details

Janwillem W.H. Kocks

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

AstraZeneca
Study protocol
Initial protocol
English (2.14 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable