Impact of IBD Activity on Frailty in Patients Over 60 Years
Impact of Inflamatory Bowel Disease Activity on Frailty in Patients Over 60 Years
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
153 participants
Apr 14, 2025
OBSERVATIONAL
Conditions
Summary
The goal of this observational, multicenter, descriptive, prospective, and longitudinal study is to evaluate the impact of IBD activity on frailty in a prospective and longitudinal cohort of patients with IBD, and also to assess the impact of frailty on the risk of hospitalization and mortality in patients with IBD aged ≥60 years. The main questions it aims to answer are: 1. Can frailty and consequently the risk of complications (adverse events, hospitalization, and mortality) be reversed through proactive treatment in frail patients with active inflammatory bowel disease? 2. Which frailty index is the most effective for predicting the risk of complications in patients with active inflammatory bowel disease? At inclusion, clinical frailty indices will be calculated. Additionally, clinical variables related to IBD and comorbidities will be recorded. During follow ups visits frailty, comorbidities, IBD activity, changes in medical treatment for IBD, adverse effects, hospitalizations, and mortality will be reassessed.
Eligibility
Inclusion Criteria3
- Patients aged ≥60 years with IBD (Crohn's disease or ulcerative colitis) diagnosed according to ECCO criteria and under follow-up in the IBD units of participating centers.
- Initiation of medical treatment (oral mesalazine, topical or systemic corticosteroids, immunosuppressants, and/or biologics) due to clinical activity based on PRO2 scales (UC: PRO >4; CD: PRO2 >14) and/or biological activity (fecal calprotectin ≥500 mg/kg, C-reactive protein ≥10 mg/L).
- Signed informed consent for inclusion.
Exclusion Criteria7
- Lack or withdrawal of informed consent.
- Unclassified/indeterminate colitis.
- Change in medical treatment solely due to adverse events.
- Initiation of treatment only with salicylates and/or topical steroids for disease activity.
- Treatment intensification to manage disease activity.
- Patients with an ostomy.
- Comorbidities with a life expectancy of less than one year.
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Locations(33)
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NCT06844318