Idiopathic Pulmonary Fibrosis (IPF)MI-IPFNCT07179562
Motivational Interviewing Program on the Self-Care in Idiopathic Pulmonary Fibrosis
A study testing "motivational interviewing" in people with Idiopathic Pulmonary Fibrosis (IPF), run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
A specific tool developed to measure self-care in patients with Idiopathic Pulmonary Fibrosis (IPF) is the SC-IPFI, which is an adaptation of an already validated instrument for COPD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis (IPF)
- What is being tested?
- "motivational interviewing"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Oct 2028
- 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
- Diagnosed with idiopathic pulmonary fibrosis according to the 2018 guidelines of the American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association,
- Diagnosed with IPF for at least 1 year,
- Aged 18 years or older,
- Able to express willingness and provide consent to participate in the study,
- In possession of a tablet, smartphone, or computer and internet access via mobile or fixed network.
Who cannot join
- Diagnosed with dementia,
- Unable to speak, read, or write in Italian,
- Legally blind or deaf,
- In advanced stage of disease (receiving oxygen therapy at 10 to 15 liters per minute).
About this study
Official title: Effectiveness of a Motivational Interviewing Program on the Self-Care Levels of Patients With Idiopathic Pulmonary Fibrosis
A specific tool developed to measure self-care in patients with Idiopathic Pulmonary Fibrosis (IPF) is the SC-IPFI, which is an adaptation of an already validated instrument for COPD. It is important to assess how motivational interviewing can influence the self-care behaviors of these patients, better evaluate their level of disease management, prevent the risk of exacerbations, and guide educational interventions.
The primary objective of this study is to evaluate the effectiveness of a motivational interviewing program delivered remotely through video calls and digital platforms in improving the levels of self-care maintenance, self-care monitoring, and self-care management in patients with IPF. The study will also assess the effectiveness of the remotely delivered motivational interviewing program on self-efficacy, anxiety, disease-specific quality of life, therapy adherence, cough, dyspnea, exacerbations, and hospital admissions.
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Being tested
- "motivational interviewing"
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"motivational interviewing"Other
Randomization for "motivational interviewing"
| Study group | Role | What they receive |
|---|---|---|
| "motivational interviewing" program | Experimental | The intervention in the experimental group will consist of a Motivational Interviewing (MI) program conducted in accordance with the Motivational Interviewing Treatment Integrity (MITI) guidelines , lasting 6 months and delivered through video calls and an online platform. Receives: Other: "motivational interviewing" |
| Standard of care | No intervention | Patients followed according to clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Il Self Care Index for Pulmonary Idiopatic Fibrosis (SC-IPFI)
The SC-IPFI was derived from a similar tool used for COPD and adapted for idiopathic pulmonary fibrosis. The instrument assesses self-care in fibrotic patients using separate scales for the three dimensions of self-care: self-care maintenance, self-care monitoring, and self-care management. Each scale has a standardized score ranging from 0 to 100, with higher scores indicating better self-care.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary Fibrosis (IPF)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to the motivational interviewing intervention group (experimental group) and the standard care group (control group).
- Masking
- None (open label)
- Enrolment
- 124 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
- NCT07179562
- Sponsor's protocol ID
- 7820
- Acronym
- MI-IPF
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 18 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 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Motivational Interviewing Program on the Self-Care Levels of Patients With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT07179562
- Acronym / sponsor ID
- MI-IPF / 7820
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 18 Sep 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.
A specific tool developed to measure self-care in patients with Idiopathic Pulmonary Fibrosis (IPF) is the SC-IPFI, which is an adaptation of an already validated instrument for COPD. It is important to assess how motivational interviewing can influence the self-care behaviors of these patients, better evaluate their level of disease management, prevent the risk of exacerbations, and guide educational interventions.
The primary objective of this study is to evaluate the effectiveness of a motivational interviewing program delivered remotely through video calls and digital platforms in improving the levels of self-care maintenance, self-care monitoring, and self-care management in patients with IPF. The study will also assess the effectiveness of the remotely delivered motivational interviewing program on self-efficacy, anxiety, disease-specific quality of life, therapy adherence, cough, dyspnea, exacerbations, and hospital admissions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to the motivational interviewing intervention group (experimental group) and the standard care group (control group).
| Arm | Type | Receives |
|---|---|---|
| "motivational interviewing" program | Experimental | Other: "motivational interviewing"The intervention in the experimental group will consist of a Motivational Interviewing (MI) program conducted in accordance with the Motivational Interviewing Treatment Integrity (MITI) guidelines , lasting 6 months and delivered through video calls and an online platform. |
| Standard of care | No intervention | –Patients followed according to clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with idiopathic pulmonary fibrosis according to the 2018 guidelines of the American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association,
- Diagnosed with IPF for at least 1 year,
- Aged 18 years or older,
- Able to express willingness and provide consent to participate in the study,
- In possession of a tablet, smartphone, or computer and internet access via mobile or fixed network.
Key exclusion criteria (4 listed)
- Diagnosed with dementia,
- Unable to speak, read, or write in Italian,
- Legally blind or deaf,
- In advanced stage of disease (receiving oxygen therapy at 10 to 15 liters per minute).
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 |
|---|---|---|
| "motivational interviewing"Randomization for "motivational interviewing" | Other | "motivational interviewing" program |
Primary outcome
Il Self Care Index for Pulmonary Idiopatic Fibrosis (SC-IPFI)
Time frame: 6 months
The SC-IPFI was derived from a similar tool used for COPD and adapted for idiopathic pulmonary fibrosis. The instrument assesses self-care in fibrotic patients using separate scales for the three dimensions of self-care: self-care maintenance, self-care monitoring, and self-care management. Each scale has a standardized score ranging from 0 to 100, with higher scores indicating better self-care.
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 18 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing "motivational interviewing" in people with Idiopathic Pulmonary Fibrosis (IPF), 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 5 inclusion and 4 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 18 Sep 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?
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?
Il Self Care Index for Pulmonary Idiopatic Fibrosis (SC-IPFI) (time frame: 6 months). 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 18 Sep 2025.