Clinical trial NCT06327360: Illness Expectations in Pulmonary Fibrosis
Official title: Between Beliefs and Expectations in Pulmonary Fibrosis: a Prospective Cohort Study With Mixed Methods.
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Pulmonary Fibrosis
Keywords: Pulmonary Fibrosis
Clinical Psychology
Rehabilitation Psychology
Illness Expectations
Illness Perceptions
Adherence to treatment
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: FIMARP ONLUS - FEDERAZIONE ITALIANA IPF E MALATTIE POLMONARI RARE
First posted: 2024-03-25
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pulmonary fibrosis, at any stage, of any gender and age

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Adherence to Pharmacological Treatment
timeFrame: from October 2023 to October 2025
measure: Adherence to Oxygen Therapy
timeFrame: from October 2023 to October 2025
measure: Adherence to Non invasive ventilation
timeFrame: from October 2023 to October 2025
measure: Illness beliefs
timeFrame: from October 2023 to October 2025
measure: Pharmacological treatment Beliefs
timeFrame: from October 2023 to October 2025
measure: Illness Expectations
timeFrame: from October 2023 to October 2025
measure: Illness Cognitions
timeFrame: from October 2023 to October 2025
Secondary outcomes:
measure: Socio-demographic variables
timeFrame: from October 2023 to October 2025
measure: Clinical and medical data
timeFrame: from October 2023 to October 2025
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
city: Milano
country: Italy
facility: Don Gnocchi Foundation
Study officials:
References:
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.
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.
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.
citation: Ley B, Collard HR. Epidemiology of idiopathic pulmonary fibrosis. Clin Epidemiol. 2013 Nov 25;5:483-92. doi: 10.2147/CLEP.S54815.
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.
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.
citation: 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.