IPFSC-IPFINCT07139925
Assessment of Self-Care in Patients With Idiopathic Pulmonary Fibrosis (IPF)
An observational study of IPF, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The adaptation of the SC-COPDI for IPF patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IPF
- What is being tested?
- Self-care of COPD Inventory (SC-COPDI)
- How many people
- 156 participants
- Where
- 1 siteItaly
- Study dates
- 9 Jan 2025to 1 Jan 2027
- Phase
- Observational
- 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
Study population: Patients diagnosed with idiopathic pulmonary fibrosis
Who may be able to join
- Patients diagnosed with idiopathic pulmonary fibrosis (IPF)
- Patients over 18 years of age
- Patients who are able to provide informed consent to participate in the study
Who cannot join
- Patients diagnosed with cognitive impairment
- Patients who are unable to speak, read, or write in Italian
- Patients who are blind or deaf
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli
Roma, Roma, 00168
About this study
Official title: Validation of a Self-Care Assessment Tool for Patients With Idiopathic Pulmonary Fibrosi
The adaptation of the SC-COPDI for IPF patients
Read the detailed description
Cross-sectional, single-center observational study. The study aims to adapt a tool designed for patients with COPD (SC-COPDI) for use with patients affected by idiopathic pulmonary fibrosis
- Conditions
- IPF
- Being tested
- Self-care of COPD Inventory (SC-COPDI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-care of COPD Inventory (SC-COPDI)Other
Self-care of COPD Inventory (SC-COPDI) - Assess the self-care of patients with IPF by adapting a tool designed for patients with COPD to those affected by IPF
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of a tool for assessing self-care in patients with IPF
To make a tool available for assessing self-care in patients with IPF by adapting an instrument designed for patients with COPD to those with IPF
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start9 Jan 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IPFStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RICHELDI LUCA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Luca Richeldi, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139925
- Sponsor's protocol ID
- 7153
- Acronym
- SC-IPFI
- Status last verified
- Jul 2025
- First submitted
- 18 Aug 2025
- Last updated
- 4 Sep 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 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Self-Care Assessment Tool for Patients With Idiopathic Pulmonary Fibrosi
- ClinicalTrials.gov ID
- NCT07139925
- Acronym / sponsor ID
- SC-IPFI / 7153
- Conditions
- IPF
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 9 Jan 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 24 Aug 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 adaptation of the SC-COPDI for IPF patients
Detailed description
Cross-sectional, single-center observational study. The study aims to adapt a tool designed for patients with COPD (SC-COPDI) for use with patients affected by idiopathic pulmonary fibrosis
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with idiopathic pulmonary fibrosis
Key inclusion criteria (3 listed)
- Patients diagnosed with idiopathic pulmonary fibrosis (IPF)
- Patients over 18 years of age
- Patients who are able to provide informed consent to participate in the study
Key exclusion criteria (3 listed)
- Patients diagnosed with cognitive impairment
- Patients who are unable to speak, read, or write in Italian
- Patients who are blind or deaf
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 |
|---|---|---|
| Self-care of COPD Inventory (SC-COPDI)Self-care of COPD Inventory (SC-COPDI) - Assess the self-care of patients with IPF by adapting a tool designed for patients with COPD to those affected by IPF | Other | – |
Primary outcome
Evaluation of a tool for assessing self-care in patients with IPF
Time frame: baseline
To make a tool available for assessing self-care in patients with IPF by adapting an instrument designed for patients with COPD to those with IPF
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 4 Sep 2025.
Related trials for IPF
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Progressive Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)
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.
Luca Richeldi principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IPF, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 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: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
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?
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?
Evaluation of a tool for assessing self-care in patients with IPF (time frame: baseline). 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 4 Sep 2025.