Impact of Inflamatory Bowel Disease Activity on Frailty in Patients Over 60 Years
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 153
- 试验地点
- 67
- 主要终点
- To evaluate the impact of inflamatory bowel disease (IBD) activity on frailty in a prospective and longitudinal cohort of patients with IBD.
研究概览
简要总结
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:
- 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?
- 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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
结局指标
主要结局
To evaluate the impact of inflamatory bowel disease (IBD) activity on frailty in a prospective and longitudinal cohort of patients with IBD.
时间窗: 12 months
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
To assess the impact of frailty on the risk of hospitalization and mortality in patients with IBD aged ≥60 years.
时间窗: 12 months
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.
次要结局
未报告次要终点