NCT06714188

Brief Summary

This study aims to develop a tool that helps the medical-nursing team in the identification of the real palliative care needs of each individual patient. Patients with newly diagnosed Idiopathic Pulmonary Fibrosis will be asked just a few simple questions in order to place them at the most appropriate level of palliative care (PC) even before the first medical contact. This would not only optimize resource allocation (e.g., allowing patients with low palliative needs to be assessed solely by the PC nurse), but also benefit patients who have difficulty leaving their homes by enabling them to receive evaluation and palliative care directly at home rather than after a hospital assessment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 19, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 3, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

March 2, 2026

Status Verified

January 1, 2026

Enrollment Period

10 months

First QC Date

November 28, 2024

Last Update Submit

February 27, 2026

Conditions

Keywords

QuestionnairePalliative CareIPF

Outcome Measures

Primary Outcomes (1)

  • Evaluation of concordance between the levels of palliative care obtained using a triage questionnaire and those derived from the clinical judgments of the dedicated pulmonologist and the dedicated palliative care physician

    The primary objective will be measured by calculating Krippendorff's alpha coefficient of reliability among the classifications obtained with the questionnaire, the clinical judgment of the pulmonologist, and the clinical judgment of the palliative care physician

    18 months

Secondary Outcomes (1)

  • Description of the degree of palliative care needs that patients with IPF present when referred to the reference pulmonology center

    18 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) established after discussion at the Multidisciplinary Interstitial Disease Meeting and referred to the APPI Fibrosi unit of the IRCCS for specialized care

You may qualify if:

  • Age ≥ 18 years.
  • New diagnosis of Idiopathic Pulmonary Fibrosis (IPF) established through a Multidisciplinary Interstitial Disease Meeting.
  • Obtaining written informed consent.

You may not qualify if:

  • Patient's inability to understand and/or respond to the questions in the questionnaire as judged by the healthcare provider.
  • Patient already receiving care from the Palliative Care Service.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Azienda Ospedaliera-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

Location

Study Officials

  • Stefano Nava, MD

    IRCCS Azienda Ospedaliero-Universitaria di Bologna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2024

First Posted

December 3, 2024

Study Start

September 19, 2023

Primary Completion

July 17, 2024

Study Completion

June 30, 2025

Last Updated

March 2, 2026

Record last verified: 2026-01

Locations