NCT06852794

Brief Summary

The present study aims to evaluate the usefulness of artificial intelligence (AI) in the back-office of an ILD (Interstitial Lung Disease) clinic.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Status
not yet 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

January 30, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 28, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

February 28, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

January 30, 2025

Last Update Submit

February 24, 2025

Conditions

Interstitial Disease

Keywords

Artificial Intelligence

Outcome Measures

Primary Outcomes (2)

  • Variation of VAS scores of clarity of the message in questionnaires administered at T1 and at T2

    15 days

  • Variation of VAS scores of empathy conveyed in questionnaires administered at T1 and at T2

    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

    1 day

  • Stratify the results by patients' demographic characteristics and past experiences with artificial intelligence systems.

    1 day

Study Arms (1)

Patients attending ILD clinic

EXPERIMENTAL
Other: Survey

Interventions

SurveyOTHER

The patients will receive questionnaires. The enrolled patients will be asked to provide feedback on the answers they read.

Patients attending ILD clinic

Eligibility Criteria

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

You may qualify if:

  • \- Patients attending ILD clinic of the IRCCS Fondazione Policlinico A. Gemelli.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Luca Richeldi, MD

CONTACT

+390630157857luca.richeldi@policlinicogemelli.it

Diana Verdirosi, Sc

CONTACT

+390630157724diana.verdirosi@policlinicogemelli.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

January 30, 2025

First Posted

February 28, 2025

Study Start

May 1, 2025

Primary Completion

September 1, 2025

Study Completion

February 1, 2026

Last Updated

February 28, 2025

Record last verified: 2025-01