Impact of IBD Activity on Frailty in Patients Over 60 Years
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: IBD. Базовые параметры: от 60 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Испания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Impact of Inflamatory Bowel Disease Activity on Frailty in Patients Over 60 Years
Обзор
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.
Подробное описание
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.
Первичные конечные точки
- To evaluate the impact of inflamatory bowel disease (IBD) activity on frailty in a prospective and longitudinal cohort of patients with IBD. [Срок оценки: 12 months]
- To assess the impact of frailty on the risk of hospitalization and mortality in patients with IBD aged ≥60 years. [Срок оценки: 12 months]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Испания · 34 центра
- Hospital Universitario Araba — Vitoria-Gasteiz
- Hospital Germans Trias i Pujol — Badalona
- Hospital de Bellvitge — L'Hospitalet de Llobregat
- Althaia Manresa — Manresa
- Hospital del Mataró — Mataró
- Consorci Sanitari de Terrassa — Terrassa
- Hospital Mútua de Terrassa — Terrassa
- Hospital Viladecans — Viladecans
- … и ещё 26 центров
Идентификаторы
NCT: NCT06844318 · FRAGIL