Impact of IBD Activity on Frailty in Patients Over 60 Years
ConditionIBD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorGrupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Patients aged ≥60 years with a diagnosis of IBD and clinical and/or biological disease activity.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
153 Participants
are grouped into 1 trial groupGroup A: Patients aged ≥60 years with a diagnosis of IBD and clinical and/or biological disease activity
Trial outcomes
Primary outcomes
1
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
Time frame
12 months2
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.
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov