跳至主要内容
临床试验/NCT06327360
NCT06327360Enrolling By Invitation不适用

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

Fondazione Don Carlo Gnocchi Onlus2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2023年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
130
试验地点
2
主要终点
Illness Expectations

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Illness Expectations

时间窗: from October 2023 to October 2025

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

Illness Cognitions

时间窗: 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

时间窗: 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

时间窗: from October 2023 to October 2025

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

Illness beliefs

时间窗: 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

时间窗: 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

时间窗: from October 2023 to October 2025

Use of Non-Invasive Ventilation (nighttime/daytime or both; prescribed and actual hours of usage).

次要结局

  • Socio-demographic variables(from October 2023 to October 2025)
  • Clinical and medical data(from October 2023 to October 2025)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eleonora Volpato

Clinical Professor

Fondazione Don Carlo Gnocchi Onlus

研究点 (2)

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