Abstract Background Functional impairment is a key driver of morbidity in inflammatory bowel disease (IBD). We hypothesized that an intensive IBD specialist nurse-led follow-up program would yield greater improvement in functional status, measured by the IBD Disk, compared with standard physician-led care. Methods In this single-center, open-label, randomized controlled trial, 102 adult patients with Crohn’s disease (CD) or ulcerative colitis (UC) starting advanced therapy were randomized (1:1) to intensive nurse-led follow-up (Arm A) or standard care (Arm B). The primary endpoint was a change in the IBD Disk summary score from baseline to week 12. Secondary endpoints included changes in serum Creactive protein (CRP), fecal calprotectin, and hemoglobin. Patients were followed to 52 and exploratory analyses of these outcomes were also performed. Intention to treat (ITT) and per-protocol (PP) analyses were performed at all time points. Results Among 102 randomized patients (Arm A n = 50, Arm B n = 52; mean age 37.1 ± 15.3 years; 52% male; CD 57%), ITT analysis at week 12 demonstrated a mean IBD Disk improvement of –51.0 ± 56.5 in Arm A versus –34.2 ± 51.6 in Arm B (difference –16.8; 95% CI –37.9 to + 4.2; p = 0.127). PP analysis (n = 98) showed a decrease of –85.8 ± 60.1 versus –60.5 ± 52.7 (difference –25.3; 95% CI –41.2 to –9.5; p = 0.0037). CRP decreased by –0.99 ± 3.21 versus –0.20 ± 2.84 mg/dL (p = 0.104); fecal calprotectin by –925.5 ± 3205.1 versus –171.2 ± 2978.3 µg/g (p = 0.177); hemoglobin rose similarly in both arms (p 0.5). Week 52 exploratory ITT and PP analyses confirmed sustained functional gains, with PP IBD Disk change remaining significant (–92.1 ± 65.2 vs –58.3 ± 58.1; p = 0.045). Conclusion Intensive nurse-led follow-up meaningfully improves functional status in IBD at 12 and 52 weeks, supporting the integration of structured specialist nurse programs into routine IBD care. References: NA Conflict of interest: Barkan, Revital: No conflict of interest Yanai, Henit: No conflict of interest Goren, Idan: No conflict of interest Fischman, Maya: No conflict of interest Avni Biron, Irit: No conflict of interest Banai Eran, Hagar: No conflict of interest Snir, Yifat: No conflict of interest Broitman, Yelena: No conflict of interest Dotan, Iris: No conflict of interest Ollech, Jacob: No conflict of interest
Barkan et al. (Thu,) studied this question.
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