NCT07486206 Optimizing the Follow-Up Journey in Interstitial Lung Disease: The OPTIMIZE-ILD-2 Trial
| NCT ID | NCT07486206 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital de Granollers |
| Condition | Interstitial Lung Disease (ILD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 152 participants |
| Start Date | 2026-03-09 |
| Primary Completion | 2028-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 152 participants in total. It began in 2026-03-09 with a primary completion date of 2028-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Jaume Bordas-Martinez, MD, PhD
PRINCIPAL INVESTIGATOR
Hospital General de Granollers
Frequently Asked Questions
Who can join the NCT07486206 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Interstitial Lung Disease (ILD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07486206 currently recruiting?
Yes, NCT07486206 is actively recruiting participants. Visit ClinicalTrials.gov or contact Hospital de Granollers to inquire about joining.
Where is the NCT07486206 trial being conducted?
This trial is being conducted at Granollers, Spain.
Who is sponsoring the NCT07486206 clinical trial?
NCT07486206 is sponsored by Hospital de Granollers. The principal investigator is Jaume Bordas-Martinez, MD, PhD at Hospital General de Granollers. The trial plans to enroll 152 participants.