NCT07486206Active, not recruiting
Optimizing the Follow-Up Journey in Interstitial Lung Disease: The OPTIMIZE-ILD-2 Trial
OPTIMIZE-ILD-2: A Randomized, Pragmatic, Parallel-Group Trial Evaluating the Impact of an Optimized Coordinated Follow-Up Circuit on Time Burden in Patients With Interstitial Lung Disease
Source: ClinicalTrials.gov · Last updated 21 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 152 (actual)
- First submitted
- 20 Feb 2026
- Start date
- 9 Mar 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Hospital de Granollers
- Diseases
- Idiopathic pulmonary fibrosis
- NCT number
- NCT07486206
What you commit to
- Study type: Interventional
- Participants enrolled: 152
- From 9 Mar 2026 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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).
- Cognitive impairment preventing informed consent or completion of questionnaires.
Other
- Inability to complete the coordinated follow-up visit for non-medical reasons (e.g., logistical impossibility).
- Participation in another interventional clinical trial that may alter visit frequency or follow-up structure.
- Patient refusal to participate or refusal to allow data collection.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital General de Granollers Coordinator of this site? Confirm its status | Granollers | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.