Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT06844318
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of IBD Activity on Frailty in Patients Over 60 Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 153}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2025-02-03', 'studyFirstSubmitQcDate': '2025-02-19', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the impact of inflamatory bowel disease (IBD) activity on frailty in a prospective and longitudinal cohort of patients with IBD.', 'timeFrame': '12 months', 'description': "The evaluation of the impact of IBD activity will be measured by Patient Reported outcomes 2 (PRO-2).\n\nIBD clinical activity measured by PRO-2 for Crohn's disease (CD) is composed by:\n\nCD-PRO2: number of liquid daily stools and abdominal pain (0=none; 1=low; 2= moderate; 3= severe).\n\nIBD clinical activity measured by PRO-2 for ulcerative colitis (UC) is composed of 2 parts:\n\nUC-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).\n\nClinic-biological activity: PRO2\\>4 in UC; PRO2\\>14 in CD"}, {'measure': 'To assess the impact of frailty on the risk of hospitalization and mortality in patients with IBD aged ≥60 years.', 'timeFrame': '12 months', 'description': '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:\n\nUnintended 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),\n\nThe result of the total score is: Frail 3-5 points, pre- frail 1-2 points, "fit" 0 points.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['eldearly'], 'conditions': ['IBD']}, 'descriptionModule': {'briefSummary': '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.\n\nThe main questions it aims to answer are:\n\n1. 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?\n2. 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.', 'detailedDescription': 'All consecutive patients meeting the selection criteria in the participating centres will be invited to participate.\n\n-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.\n\nFollow-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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged ≥60 years with a diagnosis of IBD and clinical and/or biological disease activity.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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.\n* 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).\n* Signed informed consent for inclusion.\n\nExclusion Criteria:\n\n* Lack or withdrawal of informed consent.\n* Unclassified/indeterminate colitis.\n* Change in medical treatment solely due to adverse events.\n* Initiation of treatment only with salicylates and/or topical steroids for disease activity.\n* Treatment intensification to manage disease activity.\n* Patients with an ostomy.\n* Comorbidities with a life expectancy of less than one year."}, 'identificationModule': {'nctId': 'NCT06844318', 'acronym': 'FRAGIL', 'briefTitle': 'Impact of IBD Activity on Frailty in Patients Over 60 Years', 'organization': {'class': 'OTHER', 'fullName': 'Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa'}, 'officialTitle': 'Impact of Inflamatory Bowel Disease Activity on Frailty in Patients Over 60 Years', 'orgStudyIdInfo': {'id': 'FRAGIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients aged ≥60 years with a diagnosis of IBD and clinical and/or biological disease activity', 'description': 'Patients aged ≥60 years with a diagnosis of inflamatory bowel disease (IBD) and clinical and/or biological disease activity'}]}, 'contactsLocationsModule': {'locations': [{'zip': '01009', 'city': 'Vitoria-Gasteiz', 'state': 'Alava', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Patricia Ramirez de la Piscina', 'role': 'CONTACT', 'email': 'secretariacientifica3@geteccu.org', 'phone': '+34 674682070'}], 'facility': 'Hospital Universitario Araba', 'geoPoint': {'lat': 42.84998, 'lon': -2.67268}}, {'city': 'Badalona', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Margalida Calafat', 'role': 'CONTACT', 'email': 'secretariacientifica3@geteccu.org', 'phone': '+34 674682070'}], 'facility': 'Hospital Germans Trias i Pujol', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Alexandra Ruiz', 'role': 'CONTACT', 'email': 'secretariacientifica3@geteccu.org', 'phone': '+34 674682070'}], 'facility': 'Hospital de Bellvitge', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'city': 'Manresa', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Marta Teller', 'role': 'CONTACT', 'email': 'secretariacientifica2@geteccu.org', 'phone': '635899553'}], 'facility': 'Althaia Manresa', 'geoPoint': {'lat': 41.72815, 'lon': 1.82399}}, {'city': 'Mataró', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Manuela Sampedro González', 'role': 'CONTACT', 'email': 'secretariacientifica3@geteccu.org', 'phone': '+34 674682070'}], 'facility': 'Hospital del Mataró', 'geoPoint': {'lat': 41.54211, 'lon': 2.4445}}, {'city': 'Terrassa', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'David Monfort Miquel', 'role': 'CONTACT', 'email': 'secretariacientifica2@geteccu.org', 'phone': '635899553'}], 'facility': 'Consorci Sanitari de Terrassa', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}, {'city': 'Terrassa', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Pere Borràs', 'role': 'CONTACT', 'email': 'secretariacientifica2@geteccu.org', 'phone': '635899553'}], 'facility': 'Hospital Mútua de Terrassa', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}, {'city': 'Viladecans', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Pau Gilabert', 'role': 'CONTACT', 'email': 'secretariacientifica3@geteccu.org', 'phone': '+34 674682070'}], 'facility': 'Hospital Viladecans', 'geoPoint': {'lat': 41.31405, 'lon': 2.01427}}, {'city': 'Torrelavega', 'state': 'Cantabria', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Célia Ruiz', 'role': 'CONTACT', 'email': 'secretariacientifica2@geteccu.org', 'phone': '635899553'}], 'facility': 'Hospital Sierrallana de Torrelavega', 'geoPoint': {'lat': 43.34943, 'lon': -4.04785}}, {'city': 'Toledo', 'state': 'Castille-La Mancha', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Pelayo Rodríguez', 'role': 'CONTACT', 'email': 'secretariacientifica2@geteccu.org', 'phone': '635899553'}], 'facility': 'Hospital de Toledo', 'geoPoint': {'lat': 39.8581, 'lon': -4.02263}}, {'city': 'Las Palmas de Gran Canaria', 'state': 'Las Palmas', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Daniel Ceballos', 'role': 'CONTACT', 'email': 'secretariacientifica3@geteccu.org', 'phone': '+34 674682070'}], 'facility': 'Hospital Universitario de Gran Canaria Doctor Negrín', 'geoPoint': {'lat': 28.10178, 'lon': -15.41573}}, {'city': 'San Sebastián de los Reyes', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Maricarmen Grau', 'role': 'CONTACT', 'email': 'secretariacientifica2@geteccu.org', 'phone': '635899553'}], 'facility': 'Hospital de Henares', 'geoPoint': {'lat': 40.55555, 'lon': -3.62733}}, {'city': 'Avilés', 'state': 'Principality of Asturias', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Pelayo Rodríguez, MD', 'role': 'CONTACT', 'email': 'secretariacientifica2@geteccu.org', 'phone': '635899553'}], 'facility': 'Hospital San Agustín de Avilés', 'geoPoint': {'lat': 43.55473, 'lon': -5.92483}}, {'city': 'Gijón', 'state': 'Principality of Asturias', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Pilar Varela, MD', 'role': 'CONTACT', 'email': 'secretariacientifica2@geteccu.org', 'phone': '635899553'}], 'facility': 'Hospital de Cabueñes', 'geoPoint': {'lat': 43.53573, 'lon': -5.66152}}, {'city': 'Oviedo', 'state': 'Principality of Asturias', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Lorena Cargallo, MD', 'role': 'CONTACT', 'email': 'secretariacientifica2@geteccu.org', 'phone': '635899553'}], 'facility': 'Hospital Universitario Central de Astúrias', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}, {'city': 'San Cristóbal de La Laguna', 'state': 'Santa Cruz De Tenerife', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Marta Carrillo', 'role': 'CONTACT', 'email': 'secretariacientifica3@geteccu.org', 'phone': '+34 674682070'}], 'facility': 'Hospital Universitario de Canarias', 'geoPoint': {'lat': 28.4853, 'lon': -16.32014}}, {'city': 'Alicante', 'state': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Lucía Madero', 'role': 'CONTACT', 'email': 'secretariacientifica2@geteccu.org', 'phone': '635899553'}], 'facility': 'Hospital Dr Balmis', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'city': 'Denia', 'state': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ana Crespo', 'role': 'CONTACT', 'email': 'secretariacientifica2@geteccu.org', 'phone': '635899553'}], 'facility': 'Hospital Denia', 'geoPoint': {'lat': 38.84078, 'lon': 0.10574}}, {'city': 'San Gregorio', 'state': 'Zaragoza', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Patrícia Sanz', 'role': 'CONTACT', 'email': 'secretariacientifica2@geteccu.org', 'phone': '635899553'}], 'facility': 'Hospital Royo Villanova', 'geoPoint': {'lat': 42.97801, 'lon': -2.18167}}, {'city': 'Ávila', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Rosanna Villanueva', 'role': 'CONTACT', 'email': 'secretariacientifica3@geteccu.org', 'phone': '+34 674682070'}], 'facility': 'Complejo Asistencial de Ávila', 'geoPoint': {'lat': 40.65724, 'lon': -4.69951}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Esther Garcia-Planella', 'role': 'CONTACT', 'email': 'secretariacientifica3@geteccu.org', 'phone': '+34 674682070'}], 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Burgos', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Beatriz Sicilia', 'role': 'CONTACT', 'email': 'secretariacientifica3@geteccu.org', 'phone': '+34 674682070'}], 'facility': 'Hospital Universitario de Burgos', 'geoPoint': {'lat': 42.34106, 'lon': -3.70184}}, {'city': 'Girona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'David Busquets', 'role': 'CONTACT', 'email': 'secretariacientifica2@geteccu.org', 'phone': '635899553'}], 'facility': 'Hospital Universitari Dr Josep Trueta', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}, {'city': 'Huelva', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Elena Gómez', 'role': 'CONTACT', 'email': 'secretariacientifica2@geteccu.org', 'phone': '635899553'}], 'facility': 'Hospital Juan Ramón Jiménez', 'geoPoint': {'lat': 37.26638, 'lon': -6.94004}}, {'city': 'Lugo', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Alina López', 'role': 'CONTACT', 'email': 'secretariacientifica3@geteccu.org', 'phone': '+34 674682070'}], 'facility': 'Hospital Universitario Lucus Augusti', 'geoPoint': {'lat': 43.00992, 'lon': -7.55602}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Marta Calvo', 'role': 'CONTACT', 'email': 'secretariacientifica2@geteccu.org', 'phone': '635899553'}], 'facility': 'Hospital Puerta de Hierro Majadahonda', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Júlia López', 'role': 'CONTACT', 'email': 'secretariacientifica3@geteccu.org', 'phone': '+34 674682070'}], 'facility': 'Hospital Ramon y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ángel Ponferrada', 'role': 'CONTACT', 'email': 'secretariacientifica3@geteccu.org', 'phone': '+34 674682070'}], 'facility': 'Hospital Universitario Infanta Leonor', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Ourense', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Cristina Alejandra Sánchez Gómez', 'role': 'CONTACT', 'email': 'secretariacientifica3@geteccu.org', 'phone': '+34 674682070'}], 'facility': 'Complexo Hospitalario Universitario de Ourense', 'geoPoint': {'lat': 42.33669, 'lon': -7.86407}}, {'city': 'Santa Cruz de Tenerife', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ángel Febles', 'role': 'CONTACT', 'email': 'secretariacientifica3@geteccu.org', 'phone': '+34 674682070'}], 'facility': 'Hospital Universitario Ntra. Sra. de Candelaria', 'geoPoint': {'lat': 28.46824, 'lon': -16.25462}}, {'city': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jose Mª Huguet', 'role': 'CONTACT', 'email': 'secretariacientifica2@geteccu.org', 'phone': '635899553'}], 'facility': 'Hospital General Universitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Marisa Iborra', 'role': 'CONTACT', 'email': 'secretariacientifica2@geteccu.org', 'phone': '635899553'}], 'facility': 'Hospital Universitario de la Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Zaragoza', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Yolanda Ber', 'role': 'CONTACT', 'email': 'secretariacientifica2@geteccu.org', 'phone': '635899553'}], 'facility': 'Hospital Lozano Blesa', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'centralContacts': [{'name': 'Erika Araya', 'role': 'CONTACT', 'email': 'secretariacientifica3@geteccu.org', 'phone': '+34 674682070'}, {'name': 'Anna Casas', 'role': 'CONTACT', 'email': 'secretariacientifica2@geteccu.org'}], 'overallOfficials': [{'name': 'Margalida Calafat, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Spanish Working Group on Crohn's disease and ulcerative colitis (GETECCU)"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}