跳至主要内容
临床试验/NCT07179562
NCT07179562尚未招募不适用

Effectiveness of a Motivational Interviewing Program on the Self-Care Levels of Patients With Idiopathic Pulmonary Fibrosis

Fondazione Policlinico Universitario Agostino Gemelli IRCCS0 个研究点目标入组 124 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
124
主要终点
Il Self Care Index for Pulmonary Idiopatic Fibrosis (SC-IPFI)

研究概览

简要总结

A specific tool developed to measure self-care in patients with Idiopathic Pulmonary Fibrosis (IPF) is the SC-IPFI, which is an adaptation of an already validated instrument for COPD. It is important to assess how motivational interviewing can influence the self-care behaviors of these patients, better evaluate their level of disease management, prevent the risk of exacerbations, and guide educational interventions.

The primary objective of this study is to evaluate the effectiveness of a motivational interviewing program delivered remotely through video calls and digital platforms in improving the levels of self-care maintenance, self-care monitoring, and self-care management in patients with IPF. The study will also assess the effectiveness of the remotely delivered motivational interviewing program on self-efficacy, anxiety, disease-specific quality of life, therapy adherence, cough, dyspnea, exacerbations, and hospital admissions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

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

  • Diagnosed with idiopathic pulmonary fibrosis according to the 2018 guidelines of the American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association,
  • Diagnosed with IPF for at least 1 year,
  • Aged 18 years or older,
  • Able to express willingness and provide consent to participate in the study,
  • In possession of a tablet, smartphone, or computer and internet access via mobile or fixed network.

排除标准

  • Diagnosed with dementia,
  • Unable to speak, read, or write in Italian,
  • Legally blind or deaf,
  • In advanced stage of disease (receiving oxygen therapy at 10 to 15 liters per minute).

结局指标

主要结局

Il Self Care Index for Pulmonary Idiopatic Fibrosis (SC-IPFI)

时间窗: 6 months

The SC-IPFI was derived from a similar tool used for COPD and adapted for idiopathic pulmonary fibrosis. The instrument assesses self-care in fibrotic patients using separate scales for the three dimensions of self-care: self-care maintenance, self-care monitoring, and self-care management. Each scale has a standardized score ranging from 0 to 100, with higher scores indicating better self-care.

次要结局

未报告次要终点

研究者

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

RICHELDI LUCA

Professor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

相似试验