NCT05933694

Brief Summary

To evaluate whether an artificial intelligence decision support software (ArtiQ.Spiro) improves the diagnostic accuracy of spirometry interpreted by primary care clinicians, as measured by Clinician Diagnostic Accuracy (vs Reference Standard).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
228

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

June 27, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 6, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

February 16, 2024

Status Verified

February 1, 2024

Enrollment Period

1 year

First QC Date

June 27, 2023

Last Update Submit

February 15, 2024

Conditions

Lung Disease

Outcome Measures

Primary Outcomes (1)

  • Preferred Diagnostic Performance

    A correct case is where the preferred diagnosis matches the reference final diagnosis. Units will be percentage of total cases that are correct.

    Six months

Secondary Outcomes (6)

  • Pattern interpretation

    Six months

  • Differential diagnostic performance

    Six months

  • Quality assessment performance

    Six months

  • Pattern interpretation self-rated confidence

    Six months

  • Diagnostic self-rated confidence

    Six months

  • +1 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

Participants to report 50 spirometry records alone

Intervention

EXPERIMENTAL

Participants report the same 50 spirometry records provided in the control arm with an artificial intelligence-powered spirometry interpretation report

Other: Artificial Intelligence-powered Spirometry Interpretation Report

Interventions

Artificial Intelligence-powered Spirometry Interpretation ReportOTHER

A report generated by artificial intelligence powered software that assessed technical quality of spirometry and estimates the diagnostic probability of six categories: COPD/Asthma/ILD/ Normal/Other obstructive/Other Unidentified

Also known as: ArtiQ.Spiro
Intervention

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinicians working in primary care (for at least 50% of their job plan) in the UK, who refer for or perform spirometry (typically GP, practice nurse)
  • Able to access spirometry traces on study platform
  • Provide written informed consent via study platform

You may not qualify if:

  • \. Clinicians who have completed specialist training in respiratory medicine and recognised by the General Medical Council with a right to practise as a NHS consultant in respiratory medicine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Brompton & Harefield Hospitals

Uxbridge, UB9 6JH, United Kingdom

RECRUITING

Related Publications (1)

  • Doe G, El-Emir E, Edwards GD, Topalovic M, Evans RA, Russell R, Sylvester KP, Van Orshoven K, Sunjaya AP, Scott DA, Prevost AT, Harvey J, Taylor SJ, Hopkinson NS, Kon SS, Jarrold I, Spain N, Banya W, Man WD. Comparing performance of primary care clinicians in the interpretation of SPIROmetry with or without Artificial Intelligence Decision support software (SPIRO-AID): a protocol for a randomised controlled trial. BMJ Open. 2024 Jul 1;14(6):e086736. doi: 10.1136/bmjopen-2024-086736.

    PMID: 38950987DERIVED

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • William Man

    Royal Brompton & Harefield Hospitals

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ethaar El-Emir, PhD

CONTACT

01895 823737e.el-emir@rbht.nhs.uk

George Edwards, MSc

CONTACT

01895 823737G.Edwards2@rbht.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2023

First Posted

July 6, 2023

Study Start

June 27, 2023

Primary Completion

June 27, 2024

Study Completion

September 30, 2024

Last Updated

February 16, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)