Web-based Monitoring in Children and Adolescents With Inflammatory Bowel Disease
Condition: Inflammatory Bowel Disease; Ulcerative Colitis; Crohn´s Disease
MeSH terms: Crohn Disease; Colitis; Colitis, Ulcerative; Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      The investigators hypothesize that E-health - web based monitoring of disease and treatment -
      in young patients with chronic inflammatory disease (IBD) can improve the disease course and
      quality of life.

      Adherence (to take the prescribed medicine) is difficult for young patients. In this E-health
      project the investigators seek to improve young patients (10-17 years) responsibility for
      treatment, to empower them and thereby enhance the adherence in order to achieve a more quiet
      disease course. Through the e-Health program and web-app the disease activity will be
      presented to the young patient via a simple traffic light chart and the patient will be
      guided to: continue the prescribed medication, call the physician or visit the out-patient
      clinic. In future the concept is believed also to be applicable for young patients with other
      chronic diseases.
    

Detailed description: 
      IBD's natural history is characterized by relapses (e.g. rectal bleeding, diarrhoea,
      abdominal pain, faecal urgency, fistula and anal abscess) and remissions. In children and
      adolescents the disease has a more aggressive course as compared with adults, causing a
      deterioration in the quality of life. During puberty patients are in an especially vulnerable
      period of their lives and there is a high risk for developing social disabilities due to the
      disease. Furthermore, IBD can lead to many days of absence from school and patients are at
      risk of not being able to maintain their education.

      Patients are treated medically when the disease is active, but also in quiet phases too in
      order to maintain remission. It is therefore crucial for success that patients receive
      insight into the disease and understand the importance of following the recommended
      maintenance treatment. Despite being aware of an increased risk of acute hospitalization and
      surgery, it is difficult for both adult and pediatric patients to follow the continuous
      medication (adherence). It is known that up to 50% of young patients fail to take their
      medication as directed.

      Previous studies have used E-health in the treatment of IBD patient. In M. Elkjaer et al.
      2010 study on 300 patients with mild-to-moderate UC, E-health treatment resulted in shorter
      periods of active disease (average 18 vs. 77 days in the control group), 88% were satisfied
      with their treatment using E-health and the need for outpatient visits was reduced. In
      another study, Pedersen et al. 2012, on 27 patients with CD and examining biological
      treatment, E-Health was able to optimize the timing of infliximab treatment in CD patients.
      The E-Health solution was safe to use and patients showed high adherence to the program
      (86%). To the investigators knowledge no study has previously used E-health treatment in
      children and adolescents with IBD. It is, however, the investigators belief that this
      treatment concept would be readily taken up such patients, for whom web communication, at
      least in Denmark, is already a well-integrated part of their daily lives.

      The current study consists of two projects: Project A: Patients in treatment with medicine
      administrated at home. Project B: Patients in treatment with biological infusions

      Project A: Patients in treatment with medicine administrated at home are monitored, according
      to current international guidelines, with outpatient visits every third month. Patients
      participating in the current project will be randomly split into two groups and followed for
      two years. E-health group: Web-monitoring with an annual visit to the IBD center. Control
      group: Routine outpatient controls, four times a year.

      Project B: According to current guidelines, patients receiving treatment with biologicals
      visit the outpatient clinic approximately every eighth week and treatment is given
      intravenously. During the E-health intervention, symptoms and fecal calprotectin are
      monitored closely through the web-program, and treatment will be initiated by symptoms and
      elevated FC. In this way the timing of treatment with biologicals can be optimized and
      infusions delayed with a maximum treatment-free period of 12 weeks, or earlier than 8 weeks
      if necessary.
    

Intervention name(s): Web-monitoring
Intervention type(s): Behavioral
Intervention description(s): During the E-health intervention, symptoms and FC are monitored closely through the web-program and treatment will be initiated by symptoms and elevated FC.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Inflammatory Bowel Disease; Ulcerative Colitis; Crohn´s Disease; Children; Adolescence; E-health web-monitoring; Adherence; Disease activity; Fecal Calprotectin