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

Phase 4

Completed

• Conditions: Crohn's Disease
• Interventions: Other: Treatment Algorithm for Crohn's Disease

• Registration Number: NCT01030809
• Lead Sponsor: University of Western Ontario, Canada

Brief 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

Study Timeline

• Study First Submitted: 2009-12-09
• Study First Submitted QC: 2009-12-10
• Study First Posted: 2009-12-11
• Study Start: 2010-01
• Primary Completion: 2013-09
• Study Completion: 2013-12
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-19
• Last Update Posted: 2014-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1999

Inclusion Criteria

• Documented diagnosis of Crohn's disease
• Able to speak and understand English, French or Flemish
• Access to a telephone or email/internet service
• Written informed consent must be obtained and documented

Exclusion Criteria

• Any conditions (e.g., history of alcohol or substance abuse) which in the opinion of the investigator , may interfere with the patients ability to comply with study procedures
• Participating in other investigational studies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Proportion of patients in remission at the end of the 24 month followup period. Remission is defined as a HBS< or = 4 without use of steroids for the treatment of CD. the primary analysis will be performed at the level of the practice.	24 months

Secondary Outcome Measures

Name	Time	Method
Proportion of patients in remission over study, change in mean HBS; use of CD meds, occurrence of surgery/hospitalization for CD and complications, patients' health related QOL measured by SF-36 & EQ-5D; physician/patient satisfaction with therapy.	24 months

Trial Locations

Locations (1)

Robarts Clinical Trials, Robarts Research Institute; 🇨🇦 London, Ontario, Canada