Pulmonary FibrosisCAMFPNCT06327360
Illness Expectations in Pulmonary Fibrosis
An observational study of Pulmonary Fibrosis, run by Fondazione Don Carlo Gnocchi ETS at 2 sites in Italy.
Trial summary
This study aims to delve into the constructs of illness beliefs and expectations among patients with Pulmonary Fibrosis, exploring how these beliefs and expectations may influence the treatment journey, including oxygen therapy, non-invasive ventilation therapy, and pharmacological treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Fibrosis
- What is being tested?
- Psychological questionnaires
- How many people
- 130 participants
- Where
- 2 sitesItaly
- Study dates
- 10 Oct 2023to 1 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 with pulmonary fibrosis, at any stage, of any gender and age
Who may be able to join
- Patients with pulmonary fibrosis
- Patients using oxygen therapy
- Patients using non-invasive ventilation
- Patients undergoing pharmacological treatment
- Patients who speak and understand the Italian language
Who cannot join
- Patients who do not provide their consent
- Patients without pulmonary fibrosis
- Patients with psychiatric disorders or cognitive impaiment
- Patients who don't speak or understand Italian language
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
Milan, 20122
Don Gnocchi Foundation
Milan, 20148
About this study
Official title: Between Beliefs and Expectations in Pulmonary Fibrosis: a Prospective Cohort Study With Mixed Methods.
This study aims to delve into the constructs of illness beliefs and expectations among patients with Pulmonary Fibrosis, exploring how these beliefs and expectations may influence the treatment journey, including oxygen therapy, non-invasive ventilation therapy, and pharmacological treatments.
- Conditions
- Pulmonary Fibrosis
- Being tested
- Psychological questionnaires
- Keywords
- Pulmonary Fibrosis, Clinical Psychology, Rehabilitation Psychology, Illness Expectations, Illness Perceptions, Adherence to treatment
- Medical subject headings
- Pulmonary Fibrosis, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological questionnairesOther
The questionnaires will be completed at the time of enrollment (T0), and at the 6- and 12-month follow-ups.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Pulmonary Fibrosis at the Don Gnocchi Foundation (Milan) | 42 patients Receives: Other: Psychological questionnaires | |
| Patients with Pulmonary Fibrosis at the Policlinico (Milano) | 42 Receives: Other: Psychological questionnaires | |
| Patients with Pulmonary Fibrosis at the FIMARP ONLUS | 46 Receives: Other: Psychological questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Pharmacological Treatment
Types of medications taken (Pirfenidone/Nintedanib/Other); assessed as the ratio between the received daily dose (RDD) and the prescribed daily dose (PDD); also evaluated using the Medication Adherence Report Scale (MARS-5), a 5-item questionnaire.
Measured: from October 2023 to October 2025
Adherence to Oxygen Therapy
Use of oxygen and respective quantities (liters/minute at rest and during exertion).
Measured: from October 2023 to October 2025
Adherence to Non invasive ventilation
Use of Non-Invasive Ventilation (nighttime/daytime or both; prescribed and actual hours of usage).
Measured: from October 2023 to October 2025
Illness beliefs
Assessed using the Brief Illness Perception Questionnaire (B-IPQ), a nine-question scale designed to rapidly assess cognitive and emotional representations of the illness.
Assessed using the Brief Illness Perception Questionnaire (B-IPQ), a nine-question scale designed to rapidly assess cognitive and emotional representations of the illness.
Measured: from October 2023 to October 2025
Pharmacological treatment Beliefs
Assessed using the Beliefs about Medicines Questionnaire (BMQ), a tool designed to evaluate individuals' beliefs about medications. It has been validated for use in patients with chronic illnesses and has been shown to predict treatment adherence in other groups, such as individuals with asthma.
Measured: from October 2023 to October 2025
Illness Expectations
Specific questions formulated to assess explicit illness expectations in Pulmonary Fibrosis are proposed.
Measured: from October 2023 to October 2025
Illness Cognitions
Illness Cognition Questionnaire (ICQ), a questionnaire assessing three ways of cognitively evaluating the stressful and adverse nature of a chronic illness: helplessness, acceptance, and perceived benefits.
Measured: from October 2023 to October 2025
Secondary outcomes (2)
Socio-demographic variables
Gender, age, smoking status, and number of cigarettes smoked per day. Additionally, factors such as family history of respiratory diseases, alcohol use (frequency), physical activity (frequency and type), level of education, marital status, onset of initial symptoms, and date of diagnosis will be considered.
Measured: from October 2023 to October 2025
Clinical and medical data
Weight and height (for calculation of Body Mass Index, BMI); comorbidities (diabetes, hypertension, hypercholesterolemia, presence of other conditions), perceived symptoms (e.g., dyspnea, cough, chest pain, fatigue and weakness, muscle and joint pains, weight loss...). Additionally, parameters from respiratory function tests (particularly Forced Vital Capacity (FVC) and Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO), arterial blood gas analysis) will be recorded. These data will be extracted from the latest available medical report and therefore from the last pulmonary visit conducted as part of routine clinical practice (please note that medical visits paid for by this project are not included).
Measured: from October 2023 to October 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start10 Oct 2023
- Primary completion10 Oct 2023
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pulmonary FibrosisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, FIMARP ONLUS - FEDERAZIONE ITALIANA IPF E MALATTIE POLMONARI RARE
- Responsible party
- Principal investigator, Eleonora Volpato, Fondazione Don Carlo Gnocchi ETS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327360
- Sponsor's protocol ID
- FDG_ 88-16
- Acronym
- CAMFP
- Status last verified
- Apr 2024
- First submitted
- 18 Mar 2024
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Raghu G, Chen SY, Hou Q, Yeh WS, Collard HR. Incidence and prevalence of idiopathic pulmonary fibrosis in US adults 18-64 years old. Eur Respir J. 2016 Jul;48(1):179-86. doi: 10.1183/13993003.01653-2015. Epub 2016 Apr 28.
PubMed 27126689Meyer KC. Pulmonary fibrosis, part I: epidemiology, pathogenesis, and diagnosis. Expert Rev Respir Med. 2017 May;11(5):343-359. doi: 10.1080/17476348.2017.1312346. Epub 2017 Apr 10.
PubMed 28345383Wolters PJ, Blackwell TS, Eickelberg O, Loyd JE, Kaminski N, Jenkins G, Maher TM, Molina-Molina M, Noble PW, Raghu G, Richeldi L, Schwarz MI, Selman M, Wuyts WA, Schwartz DA. Time for a change: is idiopathic pulmonary fibrosis still idiopathic and only fibrotic? Lancet Respir Med. 2018 Feb;6(2):154-160. doi: 10.1016/S2213-2600(18)30007-9.
PubMed 29413083Ley B, Collard HR. Epidemiology of idiopathic pulmonary fibrosis. Clin Epidemiol. 2013 Nov 25;5:483-92. doi: 10.2147/CLEP.S54815.
PubMed 24348069Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006 Jun;60(6):631-7. doi: 10.1016/j.jpsychores.2005.10.020.
PubMed 16731240Evers AW, Kraaimaat FW, van Lankveld W, Jongen PJ, Jacobs JW, Bijlsma JW. Beyond unfavorable thinking: the illness cognition questionnaire for chronic diseases. J Consult Clin Psychol. 2001 Dec;69(6):1026-36.
PubMed 11777106Agarwal P, Lin J, Muellers K, O'Conor R, Wolf M, Federman AD, Wisnivesky JP. A structural equation model of relationships of health literacy, illness and medication beliefs with medication adherence among patients with chronic obstructive pulmonary disease. Patient Educ Couns. 2021 Jun;104(6):1445-1450. doi: 10.1016/j.pec.2020.11.024. Epub 2020 Nov 25.
PubMed 33308880
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Between Beliefs and Expectations in Pulmonary Fibrosis: a Prospective Cohort Study With Mixed Methods.
- ClinicalTrials.gov ID
- NCT06327360
- Acronym / sponsor ID
- CAMFP / FDG_ 88-16
- Conditions
- Pulmonary Fibrosis
- Keywords
- Pulmonary Fibrosis, Clinical Psychology, Rehabilitation Psychology, Illness Expectations, Illness Perceptions, Adherence to treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, FIMARP ONLUS - FEDERAZIONE ITALIANA IPF E MALATTIE POLMONARI RARE
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 25 Mar 2024 (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.
This study aims to delve into the constructs of illness beliefs and expectations among patients with Pulmonary Fibrosis, exploring how these beliefs and expectations may influence the treatment journey, including oxygen therapy, non-invasive ventilation therapy, and pharmacological treatments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with Pulmonary Fibrosis at the Don Gnocchi Foundation (Milan) | – | Other: Psychological questionnaires42 patients |
| Patients with Pulmonary Fibrosis at the Policlinico (Milano) | – | Other: Psychological questionnaires42 |
| Patients with Pulmonary Fibrosis at the FIMARP ONLUS | – | Other: Psychological questionnaires46 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pulmonary fibrosis, at any stage, of any gender and age
Key inclusion criteria (5 listed)
- Patients with pulmonary fibrosis
- Patients using oxygen therapy
- Patients using non-invasive ventilation
- Patients undergoing pharmacological treatment
- Patients who speak and understand the Italian language
Key exclusion criteria (4 listed)
- Patients who do not provide their consent
- Patients without pulmonary fibrosis
- Patients with psychiatric disorders or cognitive impaiment
- Patients who don't speak or understand Italian language
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 |
|---|---|---|
| Psychological questionnairesThe questionnaires will be completed at the time of enrollment (T0), and at the 6- and 12-month follow-ups. | Other | Patients with Pulmonary Fibrosis at the Don Gnocchi Foundation (Milan), Patients with Pulmonary Fibrosis at the FIMARP ONLUS, Patients with Pulmonary Fibrosis at the Policlinico (Milano) |
Primary outcome
Adherence to Pharmacological Treatment
Time frame: from October 2023 to October 2025
Types of medications taken (Pirfenidone/Nintedanib/Other); assessed as the ratio between the received daily dose (RDD) and the prescribed daily dose (PDD); also evaluated using the Medication Adherence Report Scale (MARS-5), a 5-item questionnaire.
Adherence to Oxygen Therapy
Time frame: from October 2023 to October 2025
Use of oxygen and respective quantities (liters/minute at rest and during exertion).
Adherence to Non invasive ventilation
Time frame: from October 2023 to October 2025
Use of Non-Invasive Ventilation (nighttime/daytime or both; prescribed and actual hours of usage).
Illness beliefs
Time frame: from October 2023 to October 2025
Assessed using the Brief Illness Perception Questionnaire (B-IPQ), a nine-question scale designed to rapidly assess cognitive and emotional representations of the illness. Assessed using the Brief Illness Perception Questionnaire (B-IPQ), a nine-question scale designed to rapidly assess cognitive and emotional representations of the illness.
Pharmacological treatment Beliefs
Time frame: from October 2023 to October 2025
Assessed using the Beliefs about Medicines Questionnaire (BMQ), a tool designed to evaluate individuals' beliefs about medications. It has been validated for use in patients with chronic illnesses and has been shown to predict treatment adherence in other groups, such as individuals with asthma.
Illness Expectations
Time frame: from October 2023 to October 2025
Specific questions formulated to assess explicit illness expectations in Pulmonary Fibrosis are proposed.
Illness Cognitions
Time frame: from October 2023 to October 2025
Illness Cognition Questionnaire (ICQ), a questionnaire assessing three ways of cognitively evaluating the stressful and adverse nature of a chronic illness: helplessness, acceptance, and perceived benefits.
2 secondary outcomes
Socio-demographic variables
Time frame: from October 2023 to October 2025
Clinical and medical data
Time frame: from October 2023 to October 2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Background: PubMed 27126689Raghu G, Chen SY, Hou Q, Yeh WS, Collard HR. Incidence and prevalence of idiopathic pulmonary fibrosis in US adults 18-64 years old. Eur Respir J. 2016 Jul;48(1):179-86. doi: 10.1183/13993003.01653-2015. Epub 2016 Apr 28.
- Background: PubMed 28345383Meyer KC. Pulmonary fibrosis, part I: epidemiology, pathogenesis, and diagnosis. Expert Rev Respir Med. 2017 May;11(5):343-359. doi: 10.1080/17476348.2017.1312346. Epub 2017 Apr 10.
- Background: PubMed 29413083Wolters PJ, Blackwell TS, Eickelberg O, Loyd JE, Kaminski N, Jenkins G, Maher TM, Molina-Molina M, Noble PW, Raghu G, Richeldi L, Schwarz MI, Selman M, Wuyts WA, Schwartz DA. Time for a change: is idiopathic pulmonary fibrosis still idiopathic and only fibrotic? Lancet Respir Med. 2018 Feb;6(2):154-160. doi: 10.1016/S2213-2600(18)30007-9.
- Background: PubMed 24348069Ley B, Collard HR. Epidemiology of idiopathic pulmonary fibrosis. Clin Epidemiol. 2013 Nov 25;5:483-92. doi: 10.2147/CLEP.S54815.
- Background: PubMed 16731240Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006 Jun;60(6):631-7. doi: 10.1016/j.jpsychores.2005.10.020.
- Background: PubMed 11777106Evers AW, Kraaimaat FW, van Lankveld W, Jongen PJ, Jacobs JW, Bijlsma JW. Beyond unfavorable thinking: the illness cognition questionnaire for chronic diseases. J Consult Clin Psychol. 2001 Dec;69(6):1026-36.
- Background: PubMed 33308880Agarwal P, Lin J, Muellers K, O'Conor R, Wolf M, Federman AD, Wisnivesky JP. A structural equation model of relationships of health literacy, illness and medication beliefs with medication adherence among patients with chronic obstructive pulmonary disease. Patient Educ Couns. 2021 Jun;104(6):1445-1450. doi: 10.1016/j.pec.2020.11.024. Epub 2020 Nov 25.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Fibrosis, run by Fondazione Don Carlo Gnocchi ETS at 2 sites 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 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: status not confirmed, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
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?
Adherence to Pharmacological Treatment (time frame: from October 2023 to October 2025). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06327360, which also lists 7 linked publications.
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 5 Apr 2024.