Interstitial DiseaseLLM-ILDNCT06852794
USE OF ARTIFICIAL INTELLIGENCE IN A PULMONARY FIBROSIS CLINIC
A study testing Survey in people with Interstitial Disease, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
The present study aims to evaluate the usefulness of artificial intelligence (AI) in the back-office of an ILD (Interstitial Lung Disease) clinic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Disease
- What is being tested?
- Survey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients attending ILD clinic of the IRCCS Fondazione Policlinico A. Gemelli.
Who cannot join
- Patients unable or unwilling to sign the informed consent
- Patients who are senders of one of the emails chosen for the questionnaire
- Patients with manifest inability to fill out the questionnaire
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: USE OF ARTIFICIAL INTELLIGENCE IN THE BACK-OFFICE OF A SPECIALIZED MEDICAL CLINIC FOR PULMONARY FIBROSIS (LLM-ILD)
The present study aims to evaluate the usefulness of artificial intelligence (AI) in the back-office of an ILD (Interstitial Lung Disease) clinic.
- Conditions
- Interstitial Disease
- Being tested
- Survey
- Keywords
- Artificial Intelligence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
The patients will receive questionnaires. The enrolled patients will be asked to provide feedback on the answers they read.
| Study group | Role | What they receive |
|---|---|---|
| Patients attending ILD clinic | Experimental | Not described Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of VAS scores of clarity of the message in questionnaires administered at T1 and at T2
Measured: 15 days
Variation of VAS scores of empathy conveyed in questionnaires administered at T1 and at T2
Measured: 15 days
Secondary outcomes (2)
Percentage of answers recognised correctly as answers provided by AI among the total of answers flagged as provided by AI by study subjects
Measured: 1 day
Stratify the results by patients' demographic characteristics and past experiences with artificial intelligence systems.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start1 May 2025 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial DiseaseStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RICHELDI LUCA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852794
- Sponsor's protocol ID
- 7002
- Acronym
- LLM-ILD
- Status last verified
- Jan 2025
- First submitted
- 30 Jan 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- USE OF ARTIFICIAL INTELLIGENCE IN THE BACK-OFFICE OF A SPECIALIZED MEDICAL CLINIC FOR PULMONARY FIBROSIS (LLM-ILD)
- ClinicalTrials.gov ID
- NCT06852794
- Acronym / sponsor ID
- LLM-ILD / 7002
- Conditions
- Interstitial Disease
- Keywords
- Artificial Intelligence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 28 Feb 2025 (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.
The present study aims to evaluate the usefulness of artificial intelligence (AI) in the back-office of an ILD (Interstitial Lung Disease) clinic.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients attending ILD clinic | Experimental | Other: Survey |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients attending ILD clinic of the IRCCS Fondazione Policlinico A. Gemelli.
Key exclusion criteria (3 listed)
- Patients unable or unwilling to sign the informed consent
- Patients who are senders of one of the emails chosen for the questionnaire
- Patients with manifest inability to fill out the questionnaire
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 |
|---|---|---|
| SurveyThe patients will receive questionnaires. The enrolled patients will be asked to provide feedback on the answers they read. | Other | Patients attending ILD clinic |
Primary outcome
Variation of VAS scores of clarity of the message in questionnaires administered at T1 and at T2
Time frame: 15 days
Variation of VAS scores of empathy conveyed in questionnaires administered at T1 and at T2
Time frame: 15 days
2 secondary outcomes
Percentage of answers recognised correctly as answers provided by AI among the total of answers flagged as provided by AI by study subjects
Time frame: 1 day
Stratify the results by patients' demographic characteristics and past experiences with artificial intelligence systems.
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
Related trials for Interstitial Disease
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingObservational study
Single-Cell Sequencing Analysis of Radiation Pneumonitis Signals In Patients Treated For Cancer With Radiotherapy
Radiation Pneumonitis
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.
Questions about this trial
What is this clinical trial studying?
A study testing Survey in people with Interstitial Disease, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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 1 inclusion and 3 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: opening soon, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luca Richeldi, MD (+390630157857, luca.richeldi@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of VAS scores of clarity of the message in questionnaires administered at T1 and at T2 (time frame: 15 days). The study lists 2 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 28 Feb 2025.