Illness Expectations in Pulmonary Fibrosis
- Conditions
- Pulmonary Fibrosis
- Interventions
- Other: Psychological questionnaires
- Registration Number
- NCT06327360
- Lead Sponsor
- Fondazione Don Carlo Gnocchi Onlus
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 130
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with Pulmonary Fibrosis at the Don Gnocchi Foundation (Milan) Psychological questionnaires 42 patients Patients with Pulmonary Fibrosis at the FIMARP ONLUS Psychological questionnaires 46 Patients with Pulmonary Fibrosis at the Policlinico (Milano) Psychological questionnaires 42
- Primary Outcome Measures
Name Time Method Illness Expectations from October 2023 to October 2025 Specific questions formulated to assess explicit illness expectations in Pulmonary Fibrosis are proposed.
Illness Cognitions 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.
Adherence to Pharmacological Treatment 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 from October 2023 to October 2025 Use of oxygen and respective quantities (liters/minute at rest and during exertion).
Illness beliefs 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 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.
Adherence to Non invasive ventilation from October 2023 to October 2025 Use of Non-Invasive Ventilation (nighttime/daytime or both; prescribed and actual hours of usage).
- Secondary Outcome Measures
Name Time Method Socio-demographic variables from October 2023 to October 2025 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.
Clinical and medical data from October 2023 to October 2025 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).
Trial Locations
- Locations (2)
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
🇮🇹Milano, Italy
Don Gnocchi Foundation
🇮🇹Milano, Italy