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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:
All consecutive patients meeting the selection criteria in the participating centres will be invited to participate.
-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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients aged ≥60 years with a diagnosis of IBD and clinical and/or biological disease activity.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erika Araya | Contact | +34 674682070 | secretariacientifica3@geteccu.org | |
| Anna Casas | Contact | secretariacientifica2@geteccu.org |
| Name | Affiliation | Role |
|---|---|---|
| Margalida Calafat, MD, PhD | Spanish Working Group on Crohn's disease and ulcerative colitis (GETECCU) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Araba | Recruiting | Vitoria-Gasteiz | Alava | 01009 | Spain |
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| Hospital Germans Trias i Pujol | Recruiting | Badalona | Barcelona | Spain |
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| Hospital de Bellvitge | Recruiting | L'Hospitalet de Llobregat | Barcelona | Spain |
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| Althaia Manresa | Recruiting | Manresa | Barcelona | Spain |
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| Hospital del Mataró | Recruiting | Mataró | Barcelona | Spain |
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| Consorci Sanitari de Terrassa | Recruiting | Terrassa | Barcelona | Spain |
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| Hospital Mútua de Terrassa | Recruiting | Terrassa | Barcelona | Spain |
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| Hospital Viladecans | Recruiting | Viladecans | Barcelona | Spain |
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| Hospital Sierrallana de Torrelavega | Recruiting | Torrelavega | Cantabria | Spain |
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| Hospital de Toledo | Recruiting | Toledo | Castille-La Mancha | Spain |
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| Hospital Universitario de Gran Canaria Doctor Negrín | Recruiting | Las Palmas de Gran Canaria | Las Palmas | Spain |
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| Hospital de Henares | Recruiting | San Sebastián de los Reyes | Madrid | Spain |
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| Hospital San Agustín de Avilés | Recruiting | Avilés | Principality of Asturias | Spain |
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| Hospital de Cabueñes | Recruiting | Gijón | Principality of Asturias | Spain |
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| Hospital Universitario Central de Astúrias | Recruiting | Oviedo | Principality of Asturias | Spain |
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| Hospital Universitario de Canarias | Recruiting | San Cristóbal de La Laguna | Santa Cruz De Tenerife | Spain |
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| Hospital Dr Balmis | Recruiting | Alicante | Valencia | Spain |
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| Hospital Denia | Recruiting | Denia | Valencia | Spain |
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| Hospital Royo Villanova | Recruiting | San Gregorio | Zaragoza | Spain |
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| Complejo Asistencial de Ávila | Recruiting | Ávila | Spain |
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| Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | Spain |
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| Hospital Universitario de Burgos | Recruiting | Burgos | Spain |
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| Hospital Universitari Dr Josep Trueta | Recruiting | Girona | Spain |
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| Hospital Juan Ramón Jiménez | Recruiting | Huelva | Spain |
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| Hospital Universitario Lucus Augusti | Recruiting | Lugo | Spain |
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| Hospital Infanta Elena | Recruiting | Madrid | 28342 | Spain |
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| Hospital Puerta de Hierro Majadahonda | Recruiting | Madrid | Spain |
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| Hospital Ramon y Cajal | Recruiting | Madrid | Spain |
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| Hospital Universitario Infanta Leonor | Recruiting | Madrid | Spain |
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| Complexo Hospitalario Universitario de Ourense | Recruiting | Ourense | Spain |
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| Hospital Universitario Ntra. Sra. de Candelaria | Recruiting | Santa Cruz de Tenerife | Spain |
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| Hospital General Universitario de Valencia | Recruiting | Valencia | Spain |
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| Hospital Universitario de la Fe | Recruiting | Valencia | Spain |
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| Hospital Lozano Blesa | Recruiting | Zaragoza | Spain |
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