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Feasibility of a Multimodal Intervention Program to Optimize Treatment Outcomes in Ulcerative Colitis — OPTIMIZE-UC  

Ulcerative Colitis Clinical Trial

Official title:
OPTIMIZE-UC: Feasibility of a Multimodal Intervention Program to Optimize Treatment Outcomes in Ulcerative Colitis: A Prospective Pilot Study

Clinical Trial Summary

This is a prospective, interventional pilot study to assess the feasibility and optimal timing of a multimodal intervention program in Ulcerative Colitis (UC) patients with active disease as well as in patients in remission. Secondly, to demonstrate the effects of a multimodal intervention program on individual patients level and therapy outcomes.

Clinical Trial Description

Rationale: Despite considerable advances in the knowledge of UC, and a variation of treatment options, UC still impacts patients' ability to lead a normal life. Clearly, there is an unmet need to improve treatment outcomes. Prehabilitation programs in surgery have shown that the amount of complications is closely related to preoperative physical fitness, nutritional status and psychological well-being. IBD patients often search for self-management strategies to manage their symptoms, however, research focussing on a multimodal intervention approach in parallel to starting new IBD treatment is lacking. Given the potential benefits of intervention programs, limitations of current treatments in terms of improving quality of life and patients' desire for self-management options, we believe that exploring the results of a multimodal intervention program in patients with UC is of high relevance. Objective/study design: This is a prospective, interventional pilot study to assess the feasibility and optimal timing of a multimodal intervention program in UC patients. Secondly, to demonstrate the effects of a multimodal intervention program on individual patients level and therapy outcomes. Study population: Patients ≥ 18 years old, with UC. Intervention: Multimodal intervention program including an exercise program, nutritional intervention and psychological evaluation. Main study parameters/endpoints: This study assesses the feasibility of a multimodal intervention program. Secondary, assesses the effect on: - Individual patients' level, i.e. physical fitness, nutritional status, mental health, quality of life and work productivity and activity impairment. - Therapy outcomes, e.g. adherence, number and severity of (S)AEs, corticosteroid use, biochemical and clinical response/remission rates and patient reported outcomes. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05743153
Study type Interventional
Source Radboud University Medical Center
Contact Dorien Oomkens
Phone +31650084590
Email dorien.oomkens@radboudumc.nl
Status Not yet recruiting
Phase N/A
Start date October 1, 2023
Completion date October 1, 2024
View Details
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