Optimizing the Follow-Up Journey in Interstitial Lung Disease: The OPTIMIZE-ILD-2 Trial

Recruiting now · Not applicable

Conditions studied: Interstitial Lung Disease (ILD), Fibrotic Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis, Interstitial Lung Disease Due to Connective Tissue Disease (Disorder)

In brief

The OPTIMIZE-ILD-2 trial is a prospective, randomized, open-label clinical trial designed to evaluate the impact of a coordinated follow-up pathway on patients with established interstitial lung disease (ILD). In routine clinical practice, follow-up workflows for ILD are frequently fragmented, requiring multiple hospital visits for pulmonary function tests, laboratory analysis, treatment administration, and consultations with various specialists, which increases the burden for both patients and caregivers. This study compares the standard follow-up care against an optimized circuit where all routine monitoring procedures and interdisciplinary consultations are pre-bundled and scheduled within a single, coordinated hospital visit. All eligible patients under active ILD follow-up are included consecutively to ensure a pragmatic, real-world representation of the treated ILD population. The primary objective is to measure the total follow-up time burden, defined as the total home-to-home time required to complete the follow-up circuit. As a cross-sectional assessment within a longitudinal context, secondary objectives include assessing socioeconomic cost-burden, the environmental carbon footprint of the follow-up journey, health-related quality of life, and clinical frailty. Caregiver-related outcomes, including burden and experience measures, are contingent upon the presence of a primary caregiver and the provision of their independent informed consent. The design of this protocol was informed by a patient focus group and is officially endorsed by the 'AIRE' Associació Catalana de Malalts i Trasplantats Pulmonars, ensuring a patient-centered approach that prioritizes follow-up efficiency and human impact.

Key facts

Study ID

NCT07486206

Run by

Hospital de Granollers

People needed

152

Starts

2026-03-09

Expected to finish

2028-03-01

Last updated by the study team

2026-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years.
• Established diagnosis of interstitial lung disease (ILD).
• Currently receiving antifibrotic therapy, immunosuppressive therapy, or both, as part of routine ILD care.
• Under active follow-up at the participating ILD center.
• Able to attend the required follow-up procedures included in the study visit.
• Able to provide informed consent.

You may not qualify if…

• Inability to complete the coordinated follow-up visit for non-medical reasons (e.g., logistical impossibility).
• Clinical instability or acute illness interfering with planned follow-up procedures (such as respiratory infection, suspected ILD exacerbation, acute heart failure, or other acute conditions).
• Participation in another interventional clinical trial that may alter visit frequency or follow-up structure.
• Cognitive impairment preventing informed consent or completion of questionnaires.
• Patient refusal to participate or refusal to allow data collection.

Where it is running

• Hospital General de Granollers — Granollers, Barcelona, Spain (enrolling)

Full record on ClinicalTrials.gov

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