Impact of IBD Activity on Frailty in Patients Over 60 Years

NCT06844318 | Recruiting

• 1 other identifier: FRAGIL
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 34

Brief 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. 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. 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.

Conditions

IBD

Keywords

eldearly

Outcome Measures

Primary Outcomes (2)

• To evaluate the impact of inflamatory bowel disease (IBD) activity on frailty in a prospective and longitudinal cohort of patients with IBD.

  The evaluation of the impact of IBD activity will be measured by Patient Reported outcomes 2 (PRO-2). IBD clinical activity measured by PRO-2 for Crohn's disease (CD) is composed by: CD-PRO2: number of liquid daily stools and abdominal pain (0=none; 1=low; 2= moderate; 3= severe). IBD clinical activity measured by PRO-2 for ulcerative colitis (UC) is composed of 2 parts: UC-PRO2: stool number respect basal (0 =normal, same as usual; 1 = 1-2 stools more than the usual; 2 = 3-4 stools more than the usual; 3 = 5 or more stools more than the usual) and rectal bleeding (0 = none; 1 = visible blood in fences at least in half of them; 2 = visible blood in fences \> half of them or mores; 3 = only blood). Clinic-biological activity: PRO2\>4 in UC; PRO2\>14 in CD

  12 months

• To assess the impact of frailty on the risk of hospitalization and mortality in patients with IBD aged ≥60 years.

  The assessment of the impact of frailty will be measured by Fried Index. Fried Index is composed by a sum up of 5 parts, that follows: Unintended weight loss (score 0-1), Self-reported fatigue (score 0-1), Creep speed (score 0-1), Low physical activity (score 0-1), Weakness (score 0-1), The result of the total score is: Frail 3-5 points, pre- frail 1-2 points, "fit" 0 points.

  12 months

Study Arms (1)

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

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged ≥60 years with a diagnosis of IBD and clinical and/or biological disease activity.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa: lead

Study Sites (34)

Hospital Universitario Araba

Vitoria-Gasteiz, Alava, 01009, Spain

RECRUITING

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

RECRUITING

Hospital de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

RECRUITING

Althaia Manresa

Manresa, Barcelona, Spain

RECRUITING

Hospital del Mataró

Mataró, Barcelona, Spain

RECRUITING

Consorci Sanitari de Terrassa

Terrassa, Barcelona, Spain

RECRUITING

Hospital Mútua de Terrassa

Terrassa, Barcelona, Spain

RECRUITING

Hospital Viladecans

Viladecans, Barcelona, Spain

RECRUITING

Hospital Sierrallana de Torrelavega

Torrelavega, Cantabria, Spain

RECRUITING

Hospital de Toledo

Toledo, Castille-La Mancha, Spain

RECRUITING

Hospital Universitario de Gran Canaria Doctor Negrín

Las Palmas de Gran Canaria, Las Palmas, Spain

RECRUITING

Hospital de Henares

San Sebastián de los Reyes, Madrid, Spain

RECRUITING

Hospital San Agustín de Avilés

Avilés, Principality of Asturias, Spain

RECRUITING

Hospital de Cabueñes

Gijón, Principality of Asturias, Spain

RECRUITING

Hospital Universitario Central de Astúrias

Oviedo, Principality of Asturias, Spain

RECRUITING

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain

RECRUITING

Hospital Dr Balmis

Alicante, Valencia, Spain

RECRUITING

Hospital Denia

Denia, Valencia, Spain

RECRUITING

Hospital Royo Villanova

San Gregorio, Zaragoza, Spain

RECRUITING

Complejo Asistencial de Ávila

Ávila, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

RECRUITING

Hospital Universitario de Burgos

Burgos, Spain

RECRUITING

Hospital Universitari Dr Josep Trueta

Girona, Spain

RECRUITING

Hospital Juan Ramón Jiménez

Huelva, Spain

RECRUITING

Hospital Universitario Lucus Augusti

Lugo, Spain

RECRUITING

Hospital Infanta Elena

Madrid, 28342, Spain

RECRUITING

Hospital Puerta de Hierro Majadahonda

Madrid, Spain

RECRUITING

Hospital Ramon y Cajal

Madrid, Spain

RECRUITING

Hospital Universitario Infanta Leonor

Madrid, Spain

RECRUITING

Complexo Hospitalario Universitario de Ourense

Ourense, Spain

RECRUITING

Hospital Universitario Ntra. Sra. de Candelaria

Santa Cruz de Tenerife, Spain

RECRUITING

Hospital General Universitario de Valencia

Valencia, Spain

RECRUITING

Hospital Universitario de la Fe

Valencia, Spain

RECRUITING

Hospital Lozano Blesa

Zaragoza, Spain

RECRUITING

Study Officials

• Margalida Calafat, MD, PhD

  Spanish Working Group on Crohn's disease and ulcerative colitis (GETECCU)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erika Araya

CONTACT

+34 674682070; secretariacientifica3@geteccu.org

Anna Casas

CONTACT

secretariacientifica2@geteccu.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 25, 2025
• Study Start: April 14, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-05

Locations

ES (34)