Illness Expectations in Pulmonary Fibrosis

NCT06327360 | Enrolling By Invitation

• 1 other identifier: FDG_ 88-16
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 2

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.

Conditions

Pulmonary Fibrosis

Keywords

Pulmonary Fibrosis; Clinical Psychology; Rehabilitation Psychology; Illness Expectations; Illness Perceptions; Adherence to treatment

Outcome Measures

Primary Outcomes (7)

• 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

• Adherence to Oxygen Therapy

  Use of oxygen and respective quantities (liters/minute at rest and during exertion).

  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).

  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.

  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.

  from October 2023 to October 2025

• Illness Expectations

  Specific questions formulated to assess explicit illness expectations in Pulmonary Fibrosis are proposed.

  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.

  from October 2023 to October 2025

Secondary Outcomes (2)

• Socio-demographic variables

  from October 2023 to October 2025

• Clinical and medical data

  from October 2023 to October 2025

Study Arms (3)

Patients with Pulmonary Fibrosis at the Don Gnocchi Foundation (Milan)

42 patients

Other: Psychological questionnaires

Patients with Pulmonary Fibrosis at the Policlinico (Milano)

42

Other: Psychological questionnaires

Patients with Pulmonary Fibrosis at the FIMARP ONLUS

46

Other: Psychological questionnaires

Interventions

Psychological questionnaires OTHER

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

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with pulmonary fibrosis, at any stage, of any gender and age

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: collaborator
• FIMARP ONLUS - FEDERAZIONE ITALIANA IPF E MALATTIE POLMONARI RARE: collaborator

Study Sites (2)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

Milan, 20122, Italy

Location

Don Gnocchi Foundation

Milan, 20148, Italy

Location

Related Publications (7)

• 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.

  PMID: 27126689 BACKGROUND

• 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.

  PMID: 28345383 BACKGROUND

• 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.

  PMID: 29413083 BACKGROUND

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

  PMID: 24348069 BACKGROUND

• 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.

  PMID: 16731240 BACKGROUND

• 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.

  PMID: 11777106 BACKGROUND

• 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.

  PMID: 33308880 BACKGROUND

MeSH Terms

Conditions

Pulmonary Fibrosis; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Health Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 25, 2024
• Study Start: October 10, 2023
• Primary Completion: October 10, 2023
• Study Completion: October 1, 2025
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)