NCT01030809

Trial of a Treatment Algorithm for the Management of Crohn's Disease

A Cluster Randomized Controlled Trial of a Treatment Algorithm for the Management of Crohn's Disease

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,999 (actual)
• Sponsor: University of Western Ontario, Canada · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Assess if the implementation of a treatment algorithm will improve the management of Crohn's disease (CD) in comparison to usual care based gastroenterology practices.

Detailed description

Crohn's disease (CD) is a chronic inflammatory disorder of the gastrointestinal tract. During disease exacerbations, pharmacological or surgical intervention is usually needed to re-establish remission. Ideally, strategies should be employed to maintain patients in long-term remission while minimizing exposure to corticosteroids and reduce therapy-related toxicity. Nevertheless, in reality many patients with CD do not receive effective therapy and their disease often remains active, leading to uncontrolled inflammation and complications from either the underlying disease or corticosteroids. Although treatment guidelines exist, they do not adequately define treatment goals and the duration of treatment cycles is not specified Optimizing outcomes in CD requires rapid control of inflammation. Intuitively, persistent inflammation leads to persistent symptoms, tissue damage, and disease-related complications. Conventional therapy is frequently ineffective in moderate to severe CD, and is often continued for a prolonged time. Consequently, many patients are under-treated. An alternate strategy that minimizes the use of corticosteroids and encourages the earlier use of immunosuppressive agents and tumour necrosis factor (TNF) antagonists may be optimal. However it is unknown whether this approach is superior to usual care

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
OTHER	Treatment Algorithm for Crohn's Disease	Practitioners assigned to the intervention arm will be educated on the use of the treatment algorithm.

Timeline

• Start date: 2010-01-01
• Primary completion: 2013-09-01
• Completion: 2013-12-01
• First posted: 2009-12-11
• Last updated: 2014-03-20

Locations

1 site across 1 country: Canada