Self-efficacy and Well-being of Patients With Fibrotic Interstitial Lung Disease - an Observational Study
Self-efficacy and Well-being of Patients With Fibrotic Interstitial Lung Disease - an Observational Study
The goal of this observational study is to evaluate the feasibility and acceptability of a newly developed digital education and self-management program for people with fibrotic interstitial lung diseases (FILD) during inpatient pulmonary rehabilitation and outpatient interstitial lung disease (ILD) care. The study also explores whether participation in the program is associated with changes in health-related outcomes.
The main questions this study aims to answer are:
Patients who consent to participate during the implementation phase will be offered access to the digital education and self-management program. Their outcomes will be compared with those of a historical cohort of patients who received usual care before the program was introduced.
Participants will:
Fibrotic interstitial lung diseases (FILD) are a group of rare and chronic lung conditions that are often associated with persistent symptoms, reduced quality of life, and limitations in daily activities. People living with FILD frequently report unmet needs regarding disease-specific education and support for self-management. In particular, patients identify a lack of clear, understandable, and patient-centered educational resources as a major gap in current inpatient rehabilitation and outpatient interstitial lung disease (ILD) care.
To address this need, a blended digital education and self-management program was developed for patients with FILD. The program combines web-based e-learning modules with opportunities for discussion and clarification with healthcare professionals during routine inpatient rehabilitation or outpatient clinical care. The digital content addresses core and optional topics related to disease understanding, symptom management, and self-management strategies. Suggested modules are based on individual patient needs and preferences identified through initial questions within the digital platform, while all modules remain accessible to all users.
This study is an exploratory, multicenter, before-after observational cohort study with an embedded feasibility sub-study. Two cohorts are included: a historical control cohort consisting of patients treated before implementation of the digital program, and a feasibility cohort consisting of patients treated after implementation who consent to participate and receive access to the digital education and self-management program. Participants are not randomized, and investigators do not assign patients to intervention or control groups. Exposure to the program is determined by timing of implementation and patient consent.
The primary objective of the feasibility sub-study is to assess intervention feasibility, including acceptability, perceived usefulness, patient satisfaction, and adherence to the digital program. Adherence is assessed by documenting participation in and completion of the educational modules. Semi-structured interviews with patients and healthcare professionals are conducted to explore barriers and facilitators to implementation in inpatient rehabilitation and outpatient care settings.
Secondary objectives address study feasibility for a future larger effectiveness trial. These objectives include evaluating the feasibility of recruiting the targeted number of participants, retaining participants through follow-up assessments, and collecting health-related outcome data with minimal missing data.
Health-related outcomes are collected to explore patients' responsiveness to the digital education and self-management program and to inform the design of a future effectiveness trial. The primary health-related outcome is self-efficacy, assessed at multiple time points using a pulmonary rehabilitation-adapted self-efficacy measure. Secondary health-related outcomes include health-related quality of life, assessed using a disease-specific questionnaire for interstitial lung disease, as well as changes in self-efficacy at earlier follow-up time points.
Additional exploratory outcomes include functional exercise capacity derived from routinely collected clinical data, patient-reported symptoms and health status using visual analog scales, patient-reported respiratory symptoms, psychological well-being, and supplemental oxygen requirements during activity. These outcomes are collected to provide a comprehensive picture of patient experiences and to evaluate the feasibility and relevance of these measures for future studies.
The digital education and self-management program is delivered through a web-based learning management system and can be accessed via smartphone, tablet, or desktop computer. For inpatient rehabilitation patients, access is provided during the rehabilitation stay, with flexible use throughout the program and support from therapists as needed. Topics from the digital program can be discussed during routine therapy sessions, and patients retain access to the digital resources after discharge. For outpatient care patients, access is provided during an ILD clinic visit, with opportunities to discuss program content during follow-up appointments and reminders to encourage engagement.
Overall, this study aims to generate essential information on the feasibility and acceptability of implementing a digital education and self-management program for patients with FILD, while providing preliminary data on relevant health-related outcomes to support planning of a future multicenter effectiveness trial.
Inclusion criteria are:
Exclusion criteria are:
thimo.marcin@rehabern.ch+41 33 244 3048
thomas.riegler@zhaw.ch+41 (0) 58 934 64 06
Bern, 3010, Switzerland
sabina.guler@insel.ch+41 31 632 21 11
thimo.marcin@insel.ch+41 33 244 3048