AI in PRImary Care Spirometry Pathways for Diagnosis of Lung Disease

Status Active, not recruiting

Clinical Trial Summary

To investigate the feasibility of performing a future real-world randomised controlled trial to determine the clinical effectiveness of ArtiQ.Spiro in supporting diagnostic performance of primary care staff in the interpretation of spirometry

Clinical Trial Description

This is a feasibility study for a larger multicentre randomised controlled trial (RCT) assessing the impact of the ArtiQ.Spiro software on diagnostic accuracy, care processes, patient and health economic outcomes. The primary objective of this study is to assess the feasibility of a future randomised controlled trial designed to evaluate the real-world clinical effectiveness of an artificial intelligence enabled software to support the diagnostic interpretation and quality assessment of primary care spirometry. Endpoints of the current study will be focused on feasibility and acceptability outcomes. Secondary objectives of this study are to collect data on potential clinical and health economic endpoints for a future randomised controlled trial designed to evaluate the real-world clinical effectiveness of an artificial intelligence enabled software to support the diagnostic interpretation and quality assessment of primary care spirometry. This will help determine the primary endpoint for a future trial and provide data to support a sample size calculation to ensure that any future trial will have adequate power. This is a mixed methods randomised controlled feasibility trial. In PICO format: Population: Individuals with respiratory symptoms referred clinically for primary care spirometry in Hillingdon, Leicestershire, West Hampshire. Intervention: Local primary care spirometry pathway supported by additional artificial intelligence enabled software (ArtiQ.Spiro) Control: Local primary care spirometry alone. Outcomes: Feasibility outcomes with a particular focus on recruitment and retention, and acceptability of intervention and trial design. Clinical outcomes including referrer diagnostic performance and patient health status. Health economic outcomes including health care usage and economic modelling. All participants will undergo their locally agreed spirometry pathway. ;

Study Design

Related Conditions & MeSH terms

Lung Diseases

Clinical Trial Details

NCT number	NCT05865249
Study type	Interventional
Source	Royal Brompton & Harefield NHS Foundation Trust
Contact
Status	Active, not recruiting
Phase	N/A
Start date	June 3, 2023
Completion date	April 1, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

AI in PRImary Care Spirometry Pathways for Diagnosis of Lung Disease (APRIL) — APRIL

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms