Impact of Inflamatory Bowel Disease Activity on Frailty in Patients Over 60 Years

Status: Recruiting
Location: See all (31) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital Dr Balmis
RECRUITING
Alicante
Complejo Asistencial de Ávila
RECRUITING
Ávila
Hospital San Agustín de Avilés
RECRUITING
Avilés
Hospital Germans Trias i Pujol
RECRUITING
Badalona
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital Universitario de Burgos
RECRUITING
Burgos
Hospital Denia
RECRUITING
Denia
Hospital de Cabueñes
RECRUITING
Gijón
Hospital Juan Ramón Jiménez
RECRUITING
Huelva
Hospital de Bellvitge
RECRUITING
L'hospitalet De Llobregat
Hospital Universitario de Gran Canaria Doctor Negrín
RECRUITING
Las Palmas De Gran Canaria
Hospital Universitario Lucus Augusti
RECRUITING
Lugo
Hospital Puerta de Hierro Majadahonda
RECRUITING
Madrid
Hospital Ramon y Cajal
RECRUITING
Madrid
Hospital Universitario Infanta Leonor
RECRUITING
Madrid
Hospital del Mataró
RECRUITING
Mataró
Complexo Hospitalario Universitario de Ourense
RECRUITING
Ourense
Hospital Universitario Central de Astúrias
RECRUITING
Oviedo
Hospital Universitario de Canarias
RECRUITING
San Cristóbal De La Laguna
Hospital Royo Villanova
RECRUITING
San Gregorio
Hospital de Henares
RECRUITING
San Sebastián De Los Reyes
Hospital Universitario Ntra. Sra. de Candelaria
RECRUITING
Santa Cruz De Tenerife
Consorci Sanitari de Terrassa
RECRUITING
Terrassa
Hospital Mútua de Terrassa
RECRUITING
Terrassa
Hospital de Toledo
RECRUITING
Toledo
Hospital Sierrallana de Torrelavega
RECRUITING
Torrelavega
Hospital General Universitario de Valencia
RECRUITING
Valencia
Hospital Universitario de la Fe
RECRUITING
Valencia
Hospital Viladecans
RECRUITING
Viladecans
Hospital Universitario Araba
RECRUITING
Vitoria-gasteiz
Hospital Lozano Blesa
RECRUITING
Zaragoza
Contact Information
Primary
Erika Araya
secretariacientifica3@geteccu.org
+34 674682070
Backup
Anna Casas
secretariacientifica2@geteccu.org
Time Frame
Start Date: 2025-04-14
Estimated Completion Date: 2027-05
Participants
Target number of participants: 153
Treatments
Patients aged ≥60 years with a diagnosis of IBD and clinical and/or biological disease activity
Patients aged ≥60 years with a diagnosis of inflamatory bowel disease (IBD) and clinical and/or biological disease activity
Related Therapeutic Areas
Sponsors
Leads: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

This content was sourced from clinicaltrials.gov