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NCT05865249 | Active, not recruiting | Lung Diseases


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

Royal Brompton & Harefield NHS Foundation Trust

Brief 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

Condition or disease

Lung Diseases

Intervention/treatment

Spirometry decision support software (ArtiQ.Spiro)

Phase

Not Applicable

Detailed 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 Type : Interventional
Estimated Enrollment : 63 participants
Masking : Single
Primary Purpose : Other
Official Title : Real-world Evaluation of an Artificial-Intelligence Support Software (ArtiQ.Spiro) in Primary Care Spirometry Pathways for the Detection of Lung Disease
Actual Study Start Date : June 3, 2023
Estimated Primary Completion Date : January 22, 2024
Estimated Study Completion Date : April 1, 2024
Arm Intervention/treatment

No Intervention: Control

In participants randomised to the control group, the primary care referrer will receive the spirometry report plus any additional information as per local spirometry pathway. The primary care referrer will not receive an interpretation and quality assessment report generated by ArtiQ.Spiro.

Other: Intervention

In participants randomised to the intervention group, the primary care referrer will receive the spirometry report plus any additional information as per local spirometry pathway plus an interpretation and quality assessment report generated by ArtiQ.Spiro.

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Adults ≥18 years, irrespective of sex, ethnicity, disability, sexual orientation, marital status, educational level,
  • Referral by GP or nominated representative for primary care spirometry during study period.
  • Patients able to provide informed consent.
Exclusion Criteria
  • Age <18yrs; Absolute contraindication to spirometry.
  • Any locally defined exclusion to spirometry.

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

Location Details


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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

United Kingdom,

Gillian Doe

Leicester, United Kingdom, Damn it

Not yet recruiting

United Kingdom,

Harefield Hospital

Uxbridge, United Kingdom, Fragrant Tajha

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