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OPTIMIZE-ILD-2NCT07486206

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

StatusActive, Not Recruiting
PhaseNot applicable
Primary completion (estimated)
Track this trial

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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Notable Eligibility criteria expanded, about 11 words Show 7 more changesShow less
    • Enrollment closed, study ongoing
    • Primary completion moved earlier from Mar 1, 2028 to Jun 30, 2027
    • Study completion moved earlier from Mar 1, 2028 to Sep 30, 2027
    • Secondary endpoints revised (19)
    • Site details revised
    • Collaborators expanded, about 6 words
    • Study description expanded, about 2 words
  2. Minor Secondary endpoints: 14 to 19
    • Study description expanded, about 58 words
    v2
  3. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Total Follow-Up Time Burden (Home-to-Home and In-Hospital Time)
Timeframe: Through study completion, an average of 6 months after inclusion.

Secondary (19)

Patient and Caregiver Socioeconomic Cost-Burden
Hospital Direct and Operational Costs
Carbon Footprint of the ILD Follow-Up Pathway
EQ-5D-5L Health-Related Quality of Life Questionnaire
King's Brief Interstitial Lung Disease (K-BILD) Questionnaire
Show 14 moreShow less
Generalized Anxiety Disorder 7-item Scale (GAD-7)
Patient Health Questionnaire-9 (PHQ-9)
Clinical Frailty Scale (CFS)
Social-Familial Evaluation Scale (TSO version)
Oslo-3 Social Support Scale
Social Work Screening and Referral
Patient-Reported Experience Measures (PREMs) - Patient
Patient-Reported Experience Measures (PREMs) - Caregiver
Caregiver Burden Inventory - Shortened Version (CBI-15)
Interdisciplinary Professional Experience (Professional-PREMs)
Patient Global Impression of Change (PGIC) - Patient
Patient Global Impression of Change (PGIC) - Caregiver
Patient Global Impression of Change (PGIC) - Professional
Sociodemographic Determinants of Equity and Access

Arms and interventions

Standard ILD Follow-Up PathwayActive comparator

Participants in this arm will follow the standard ILD follow-up pathway, in which routine components of ILD monitoring-such as pulmonary function tests, six-minute walk test when performed, laboratory analyses, imaging when clinically indicated, pharmacy consultations, nursing assessments and medical visits-are scheduled independently by each department according to routine workflows and availability. These procedures usually take place on separate days, and completing a full follow-up cycle commonly requires multiple hospital visits. The organizational structure of care, scheduling processes and clinical content remain unchanged.

Optimized One-Day ILD Follow-Up CircuitExperimental

Participants in this arm will follow an optimized coordinated ILD follow-up circuit in which all required procedures are pre-scheduled and consolidated into a single structured one-day visit. This includes medical consultation, nursing assessment, pharmacy review, pulmonary function testing, laboratory analyses and imaging when clinically indicated. When needed, rheumatology or internal medicine evaluation is incorporated into the same coordinated visit. The intervention does not introduce new tests, does not modify clinical decision-making and does not alter hospital prioritization or waiting-list rules; it reorganizes the timing and coordination of existing procedures to reduce fragmentation and overall time burden.

Other: Standard ILD Follow-Up Pathway, Optimized One-Day ILD Follow-Up Circuit

Sites

1 site in 1 country

  • Hospital General de GranollersGranollers, Barcelona, Spain