Lung DiseasesAPRILNCT05865249
AI in PRImary Care Spirometry Pathways for Diagnosis of Lung Disease (APRIL)
A study testing Spirometry decision support software (ArtiQ.Spiro) in people with Lung Diseases, run by Royal Brompton & Harefield NHS Foundation Trust at 2 sites in United Kingdom.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases
- What is being tested?
- Spirometry decision support software (ArtiQ.Spiro)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 3 Jun 2023to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Age <18yrs; Absolute contraindication to spirometry.
- Any locally defined exclusion to spirometry.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Gillian Doe
Leicester, LE3 9QP
Harefield Hospital
Uxbridge, UB9 6JH
About this study
Official title: Real-world Evaluation of an Artificial-Intelligence Support Software (ArtiQ.Spiro) in Primary Care Spirometry Pathways for the Detection of Lung Disease
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
Read the 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.
- Conditions
- Lung Diseases
- Being tested
- Spirometry decision support software (ArtiQ.Spiro)
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spirometry decision support software (ArtiQ.Spiro)Other
Also called ArtiQ.Spiro
ArtiQ.Spiro is a decision support software that combines two sub-components - one focussing on quality assessment (ArtiQ.QC), and one on spirometry interpretation (ArtiQ.PFT). It is intended to be used as an adjunct to spirometry to assist with the grading of spirometry quality and the interpretation of spirometry by providing the probability of six disease / or no disease categories.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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. |
| Intervention | Other | 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. Receives: Other: Spirometry decision support software (ArtiQ.Spiro) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification and recruitment of eligible participants
Contributing data: Screening \& recruitment log and trial consort diagram. Progression criteria: Green (≥80% screened eligible, ≥60% eligible recruited), Amber (60-79% screened eligible, 40 - 59% eligible recruited), Red (<60% screened eligible, <40% eligible recruited)
Measured: Six months
Participant retention at follow-up
Contributing data: Participation data and Trial Consort diagram. Progression criteria: Green (≥75% retained at 3 months, ≥60% retained at 6 months), Amber (60-75% retained at 3 months, 40-59% retained at 6 months), Red (<60% retained at 3 months, <40% retained at 6 months).
Measured: Six months
Fidelity of randomisation
Contributing data: Numbers randomised to control/intervention groups and baseline distribution of characteristics of intervention and control groups.
Progression criteria: Green: <10% difference in sample size, proportion of women, proportion of non-white ethnicity, proportion of > 65 years between control/intervention for each site. Amber: <15% difference in above criteria; Red: >15% difference in above criteria.
Measured: Six months
Fidelity of intervention delivery
Contributing data: Email Logs, and Primary Care Referrer Questionnaire. Progression Criteria: Green (≥90% primary care referrers of the participants in the intervention group sent ArtiQ.Spiro report, ≥90% primary care referrers of the participants in the intervention group accessed ArtiQ.Spiro report for interpretation). Amber (85-94% primary care referrers of the participants in the intervention group sent ArtiQ.Spiro report, 75-89% primary care referrers of the participants in the intervention group accessed ArtiQ.Spiro report for interpretation). Red (<85% primary care referrers of the participants in the intervention group sent ArtiQ.Spiro report, <75% primary care referrers of the participants in the intervention group accessed ArtiQ.Spiro report for interpretation).
Measured: Six months
Contamination of control groups
Contributing data: Email Logs. Progression Criteria: Green (≤10% primary care referrers of the participants in the control group receiving ArtiQ.Spiro report). Amber (11-15% primary care referrers of the participants in the control group receiving ArtiQ.Spiro report) Red (>15% primary care referrers of the participants in the control group receiving ArtiQ.Spiro report)
Measured: Six months
Acceptability of the intervention to referrers, spirometry practitioners and participants
Contributing data: Stakeholder focus groups. Progression criteria: Green (Reported as acceptable (or can be with minimal modification). Amber (Reported as acceptable with modification).Red (Intervention not acceptable).
Measured: Six months
Acceptability of outcome measures and their timing
Contributing data: Stakeholder focus groups, and Clinical Outcome Measure collection. Progression criteria: Green (Reported as acceptable or can be with minimal modification, Missing data of ≤10% for each measure).Amber (Reported as acceptable with modification, 11-25% missing data for each measure). Red: (Intervention not acceptable, >25% missing data for each measure).
Measured: Six months
Diagnostic accuracy of ArtiQ.Spiro compared with reference standard
Contributing data: Diagnostic accuracy of ArtiQ.Spiro compared with reference standard. Progression criteria: Green: ≥ 80%, Amber: 65-79%, Red: <65%.
Measured: Six months
Data collector blinding
Contributing data: Participation data. Progression criteria: Green (Blinding maintained for ≥85% participants), Amber (Blinding maintained for 84-70%), Red (Blinding maintained for <70%).
Measured: Six months
Secondary outcomes (10)
Spirometry Quality Assessment Performance (vs Reference Standard)
Referrers will be asked to rate the quality of the spirometry of the participant (Acceptable, usable, unusable/unacceptable) based on spirometry report (with or without ArtiQ.Spiro report). This will the be compared with Reference Standard(panel of specialists)
Measured: Six months
Primary Care Referrer Quality Assessment Confidence
Referrers will be asked to rate the confidence in their quality assessment on a Likert scale (from 0: Very unsure to 10: Very confident).
Measured: Six months
Primary Care Referrer Technical/Pattern Interpretation
Referrer will be asked to provide their Technical/Pattern Interpretation of the spirometry report received (Normal, Obstructive, Restrictive, Mixed), and their confidence in their technical/pattern interpretation.
Measured: Six months
Primary Care Referrer Technical/Pattern Interpretation Confidence
Referrers will be asked to rate their confidence in their Technical/Pattern Interpretation on a Likert scale (from 0: Very unsure to 10: Very confident).
Measured: Six months
Primary Care Referrer Diagnostic Performance (versus Reference Standard)
Referrers will be asked to provide a preferred diagnosis based on spirometry report (with/without ArtiQ.Spiro report) and information from primary care records.
Measured: Six months
Primary Care Referrer Diagnostic Confidence
Referrers will be asked to rate the confidence in their diagnosis on a continuous visual analogue scale (from 0: Very unsure to 10: Very confident).
Measured: Six months
Patient health status
Health Status will be measured by the EQ5D5L at baseline, 3 and 6 months post spirometry.
Measured: Six months
Heath and social care usage
This will be measured using a Patient Healthcare Resource Use Questionnaire at baseline, 3 and 6 months post spirometry.
Measured: Six months
Health economic modelling
The health economic analysis will compare health-related costs and benefits of ArtiQ.Spiro supported spirometry with standard spirometry pathways, as observed within the study.
Measured: Six months
Focus groups
Three focus groups will be conducted, comprising trial patient participants, primary care referrers and spirometry practitioners. These will be used to assess feasibility and acceptability of the trial procedures, intervention, trial outcomes.
Measured: Six months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start3 Jun 2023
- Primary completion22 Jan 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865249
- Sponsor's protocol ID
- IRAS324175
- Acronym
- APRIL
- Status last verified
- Jan 2024
- First submitted
- 24 Apr 2023
- Last updated
- 16 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Evaluation of an Artificial-Intelligence Support Software (ArtiQ.Spiro) in Primary Care Spirometry Pathways for the Detection of Lung Disease
- ClinicalTrials.gov ID
- NCT05865249
- Acronym / sponsor ID
- APRIL / IRAS324175
- Conditions
- Lung Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 3 Jun 2023 (actual)
- Primary completion
- 22 Jan 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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. |
| Intervention | Other | Other: Spirometry decision support software (ArtiQ.Spiro)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Age <18yrs; Absolute contraindication to spirometry.
- Any locally defined exclusion to spirometry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spirometry decision support software (ArtiQ.Spiro)Also: ArtiQ.SpiroArtiQ.Spiro is a decision support software that combines two sub-components - one focussing on quality assessment (ArtiQ.QC), and one on spirometry interpretation (ArtiQ.PFT). It is intended to be used as an adjunct to spirometry to assist with the grading of spirometry quality and the interpretation of spirometry by providing the probability of six disease / or no disease categories. | Other | Intervention |
Primary outcome
Identification and recruitment of eligible participants
Time frame: Six months
Contributing data: Screening \& recruitment log and trial consort diagram. Progression criteria: Green (≥80% screened eligible, ≥60% eligible recruited), Amber (60-79% screened eligible, 40 - 59% eligible recruited), Red (<60% screened eligible, <40% eligible recruited)
Participant retention at follow-up
Time frame: Six months
Contributing data: Participation data and Trial Consort diagram. Progression criteria: Green (≥75% retained at 3 months, ≥60% retained at 6 months), Amber (60-75% retained at 3 months, 40-59% retained at 6 months), Red (<60% retained at 3 months, <40% retained at 6 months).
Fidelity of randomisation
Time frame: Six months
Contributing data: Numbers randomised to control/intervention groups and baseline distribution of characteristics of intervention and control groups. Progression criteria: Green: <10% difference in sample size, proportion of women, proportion of non-white ethnicity, proportion of > 65 years between control/intervention for each site. Amber: <15% difference in above criteria; Red: >15% difference in above criteria.
Fidelity of intervention delivery
Time frame: Six months
Contributing data: Email Logs, and Primary Care Referrer Questionnaire. Progression Criteria: Green (≥90% primary care referrers of the participants in the intervention group sent ArtiQ.Spiro report, ≥90% primary care referrers of the participants in the intervention group accessed ArtiQ.Spiro report for interpretation). Amber (85-94% primary care referrers of the participants in the intervention group sent ArtiQ.Spiro report, 75-89% primary care referrers of the participants in the intervention group accessed ArtiQ.Spiro report for interpretation). Red (<85% primary care referrers of the participants in the intervention group sent ArtiQ.Spiro report, <75% primary care referrers of the participants in the intervention group accessed ArtiQ.Spiro report for interpretation).
Contamination of control groups
Time frame: Six months
Contributing data: Email Logs. Progression Criteria: Green (≤10% primary care referrers of the participants in the control group receiving ArtiQ.Spiro report). Amber (11-15% primary care referrers of the participants in the control group receiving ArtiQ.Spiro report) Red (>15% primary care referrers of the participants in the control group receiving ArtiQ.Spiro report)
Acceptability of the intervention to referrers, spirometry practitioners and participants
Time frame: Six months
Contributing data: Stakeholder focus groups. Progression criteria: Green (Reported as acceptable (or can be with minimal modification). Amber (Reported as acceptable with modification).Red (Intervention not acceptable).
Acceptability of outcome measures and their timing
Time frame: Six months
Contributing data: Stakeholder focus groups, and Clinical Outcome Measure collection. Progression criteria: Green (Reported as acceptable or can be with minimal modification, Missing data of ≤10% for each measure).Amber (Reported as acceptable with modification, 11-25% missing data for each measure). Red: (Intervention not acceptable, >25% missing data for each measure).
Diagnostic accuracy of ArtiQ.Spiro compared with reference standard
Time frame: Six months
Contributing data: Diagnostic accuracy of ArtiQ.Spiro compared with reference standard. Progression criteria: Green: ≥ 80%, Amber: 65-79%, Red: <65%.
Data collector blinding
Time frame: Six months
Contributing data: Participation data. Progression criteria: Green (Blinding maintained for ≥85% participants), Amber (Blinding maintained for 84-70%), Red (Blinding maintained for <70%).
10 secondary outcomes
Spirometry Quality Assessment Performance (vs Reference Standard)
Time frame: Six months
Primary Care Referrer Quality Assessment Confidence
Time frame: Six months
Primary Care Referrer Technical/Pattern Interpretation
Time frame: Six months
Primary Care Referrer Technical/Pattern Interpretation Confidence
Time frame: Six months
Primary Care Referrer Diagnostic Performance (versus Reference Standard)
Time frame: Six months
Primary Care Referrer Diagnostic Confidence
Time frame: Six months
Patient health status
Time frame: Six months
Heath and social care usage
Time frame: Six months
Health economic modelling
Time frame: Six months
Focus groups
Time frame: Six months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spirometry decision support software (ArtiQ.Spiro) in people with Lung Diseases, run by Royal Brompton & Harefield NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification and recruitment of eligible participants (time frame: Six months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024.