Impact of IBD Activity on Frailty in Patients Over 60 Years
NCT ID: NCT06844318
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
153 participants
OBSERVATIONAL
2025-04-14
2027-05-31
Brief Summary
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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.
Detailed Description
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-At inclusion, 4 clinical frailty indices (CFS-Clinical Frailty Scale, FRAGIL-VIG, Fried, VES-13) will be calculated. In addition, clinical variables on IBD (diagnosis, phenotype, extraintestinal manifestations, perianal disease, time of evolution of the disease, active treatments at the time of inclusion, treatment initiated, diagnostic tests available at the time of inclusion) and comorbidities (allowing calculation of the Charlson and Cumulative Illness Rating Scale for Geriatriscs \[CIRS-G\] indices) will be recorded.
Follow-up: a total of 3 follow-up visits will be conducted (at 3, 6 and 12 months) where frailty, comorbidities, IBD activity, changes in IBD medical treatment, adverse effects, hospitalisations and mortality will be reassessed.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
60 Years
ALL
No
Sponsors
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Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
OTHER
Responsible Party
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Principal Investigators
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Margalida Calafat, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Spanish Working Group on Crohn's disease and ulcerative colitis (GETECCU)
Locations
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Hospital Universitario Araba
Vitoria-Gasteiz, Alava, Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Althaia Manresa
Manresa, Barcelona, Spain
Hospital del Mataró
Mataró, Barcelona, Spain
Consorci Sanitari de Terrassa
Terrassa, Barcelona, Spain
Hospital Mútua de Terrassa
Terrassa, Barcelona, Spain
Hospital Viladecans
Viladecans, Barcelona, Spain
Hospital Sierrallana de Torrelavega
Torrelavega, Cantabria, Spain
Hospital de Toledo
Toledo, Castille-La Mancha, Spain
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, Las Palmas, Spain
Hospital de Henares
San Sebastián de los Reyes, Madrid, Spain
Hospital San Agustín de Avilés
Avilés, Principality of Asturias, Spain
Hospital de Cabueñes
Gijón, Principality of Asturias, Spain
Hospital Universitario Central de Astúrias
Oviedo, Principality of Asturias, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
Hospital Dr Balmis
Alicante, Valencia, Spain
Hospital Denia
Denia, Valencia, Spain
Hospital Royo Villanova
San Gregorio, Zaragoza, Spain
Complejo Asistencial de Ávila
Ávila, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario de Burgos
Burgos, , Spain
Hospital Universitari Dr Josep Trueta
Girona, , Spain
Hospital Juan Ramón Jiménez
Huelva, , Spain
Hospital Universitario Lucus Augusti
Lugo, , Spain
Hospital Puerta de Hierro Majadahonda
Madrid, , Spain
Hospital Ramon y Cajal
Madrid, , Spain
Hospital Universitario Infanta Leonor
Madrid, , Spain
Complexo Hospitalario Universitario de Ourense
Ourense, , Spain
Hospital Universitario Ntra. Sra. de Candelaria
Santa Cruz de Tenerife, , Spain
Hospital General Universitario de Valencia
Valencia, , Spain
Hospital Universitario de la Fe
Valencia, , Spain
Hospital Lozano Blesa
Zaragoza, , Spain
Countries
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Central Contacts
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Facility Contacts
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Patricia Ramirez de la Piscina
Role: primary
Margalida Calafat
Role: primary
Alexandra Ruiz
Role: primary
Marta Teller
Role: primary
Manuela Sampedro González
Role: primary
David Monfort Miquel
Role: primary
Pere Borràs
Role: primary
Pau Gilabert
Role: primary
Célia Ruiz
Role: primary
Pelayo Rodríguez
Role: primary
Daniel Ceballos
Role: primary
Maricarmen Grau
Role: primary
Pelayo Rodríguez, MD
Role: primary
Pilar Varela, MD
Role: primary
Lorena Cargallo, MD
Role: primary
Marta Carrillo
Role: primary
Lucía Madero
Role: primary
Ana Crespo
Role: primary
Patrícia Sanz
Role: primary
Rosanna Villanueva
Role: primary
Esther Garcia-Planella
Role: primary
Beatriz Sicilia
Role: primary
David Busquets
Role: primary
Elena Gómez
Role: primary
Alina López
Role: primary
Marta Calvo
Role: primary
Júlia López
Role: primary
Ángel Ponferrada
Role: primary
Cristina Alejandra Sánchez Gómez
Role: primary
Ángel Febles
Role: primary
Jose Mª Huguet
Role: primary
Marisa Iborra
Role: primary
Yolanda Ber
Role: primary
Other Identifiers
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FRAGIL
Identifier Type: -
Identifier Source: org_study_id