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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Crohn's Disease

Intervention / Treatment
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* Other: Treatment Algorithm for Crohn's Disease


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care practice<br>Patients managed according to usual care practices | |
| Active Comparator: Treatment Algorithm<br>Practitioners assigned to the intervention arm will be educated on the use of the treatment algorithm. | Other: Treatment Algorithm for Crohn's Disease<br>* Practitioners assigned to the intervention arm will be educated on the use of the treatment algorithm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's disease, community based gastroenterology practices Canada and Belgium, Cluster randomization controlled trial, Remission, Corticosteroids, Documented diagnosis of Crohn's disease