Illness Expectations in Pulmonary Fibrosis

Pulmonary Fibrosis Clinical Trial

— CAMFP  

Official title:

Between Beliefs and Expectations in Pulmonary Fibrosis: a Prospective Cohort Study With Mixed Methods.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06327360
• Other study ID #: FDG_ 88-16
• Status: Enrolling by invitation
• Start date: October 10, 2023
• Est. completion date: October 1, 2025

Study information

• Verified date: April 2024
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 130
• Est. completion date: October 1, 2025
• Est. primary completion date: October 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Fibrosis
• Pulmonary Fibrosis

Intervention

Other:
• Psychological questionnaires
The questionnaires will be completed at the time of enrollment (T0), and at the 6- and 12-month follow-ups.

Locations

Country	Name	City	State
Italy	Don Gnocchi Foundation	Milano
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano	Milano

Sponsors (3)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus	FIMARP ONLUS - FEDERAZIONE ITALIANA IPF E MALATTIE POLMONARI RARE, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

References & Publications (7)

Agarwal 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. — View Citation

Broadbent 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. — View Citation

Evers 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. — View Citation

Ley B, Collard HR. Epidemiology of idiopathic pulmonary fibrosis. Clin Epidemiol. 2013 Nov 25;5:483-92. doi: 10.2147/CLEP.S54815. — View Citation

Meyer 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. — View Citation

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. — View Citation

Wolters 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	from October 2023 to October 2025
Primary	Adherence to Oxygen Therapy	Use of oxygen and respective quantities (liters/minute at rest and during exertion).	from October 2023 to October 2025
Primary	Adherence to Non invasive ventilation	Use of Non-Invasive Ventilation (nighttime/daytime or both; prescribed and actual hours of usage).	from October 2023 to October 2025
Primary	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.	from October 2023 to October 2025
Primary	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.	from October 2023 to October 2025
Primary	Illness Expectations	Specific questions formulated to assess explicit illness expectations in Pulmonary Fibrosis are proposed.	from October 2023 to October 2025
Primary	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.	from October 2023 to October 2025
Secondary	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.	from October 2023 to October 2025
Secondary	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).	from October 2023 to October 2025