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Web-based Monitoring in Children and Adolescents With Inflammatory Bowel Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Hvidovre University Hospital
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Katrine Carlsen, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01860651
First received: May 20, 2013
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Inflammatory Bowel Disease
Ulcerative Colitis
Crohn´s Disease
Behavioral: Web-monitoring

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Patient Empowerment: Web-based Monitoring in Children and Adolescents With Inflammatory Bowel Disease for Better Quality of Treatment

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Adherence [ Time Frame: Prospective, each third month in 2 years ] [ Designated as safety issue: No ]
    Participants assess their adherence to treatment using a Visual Analog Scale (VAS) and Medicine Adherence Report Scale (MARS) on the web-program every three months. Indirectly adherence will be measured by disease activity.


Secondary Outcome Measures:
  • Disease activity [ Time Frame: Prospective, each third month, - disease activity each month(project A) or week(project B), in 2 years ] [ Designated as safety issue: No ]
    Disease activity (aPCDAI, PUCAI)

  • Fecal Calprotectin [ Time Frame: Prospective, each third month, - disease activity each month(project A) or week(project B), in 2 years ] [ Designated as safety issue: No ]
    Fecal Calprotectin (FC) in stool sample

  • Steroid dose [ Time Frame: Prospective, each third month, - disease activity each month(project A) or week(project B), in 2 years ] [ Designated as safety issue: No ]
    Number of medical treatments and cumulative steroid dose

  • Surgery rate [ Time Frame: Prospective, each third month, - disease activity each month(project A) or week(project B), in 2 years ] [ Designated as safety issue: No ]
    Need for surgery

  • Absence from school [ Time Frame: Prospective, each third month, - disease activity each month(project A) or week(project B), in 2 years ] [ Designated as safety issue: No ]
    Number of days absence from school

  • Medical treatment [ Time Frame: Prospective, each third month, - disease activity each month(project A) or week(project B), in 2 years ] [ Designated as safety issue: No ]
    The need for dose escalation

  • Contact to the hospital [ Time Frame: Prospective, each third month, - disease activity each month(project A) or week(project B), in 2 years ] [ Designated as safety issue: No ]
    Need for outpatient visits and need for telephone contact to the doctor

  • Frequency of biological treatment [ Time Frame: Prospective, each third month, - disease activity each month(project A) or week(project B), in 2 years ] [ Designated as safety issue: No ]
    In patients treated with biological: dose of biological and number of weeks between treatments


Estimated Enrollment: 96
Study Start Date: September 2013
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Web-monitoring

There is two arms for intervention:

1) Patients in treatment with medicine administrated at home and 2) patients in treatment with biologicals.

Behavioral: Web-monitoring
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.
No Intervention: Control

Patients in treatment with medicine administrated at home: routine outpatient controls, four times a year.

Patients in treatment with biologicals: retrospective routine treatment algorithm


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.

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • IBD diagnosis according to the Copenhagen and Porto criteria
  • Aged between 10-17 years
  • Fluent in Danish
  • Access to the internet
  • Patients in treatment with infliximab must have completed the induction period (i.e. minimum six week after start-up of treatment).

Exclusion Criteria:

  • Insufficient Danish language skills
  • Lack of intellectual capacity
  • Growth retardation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01860651

Contacts
Contact: Katrine Carlsen, MD +4538689881 katrine.carlsen@regionh.dk

Locations
Denmark
Department of Pediatrics, Hvidovre Hospital Recruiting
Hvidovre, Denmark, 2650
Contact: Katrine Carlsen, MD    +4538689881    katrine.carlsen@regionh.dk   
Principal Investigator: Katrine Carlsen, MD         
Sponsors and Collaborators
Hvidovre University Hospital
University of Copenhagen
Investigators
Principal Investigator: Katrine Carlsen, MD Department of Pediatrics, Hvidovre Hospital
Study Chair: Vibeke Wewer, MD, PhD Department of Pediatrics, Hvidovre Hospital
Study Chair: Pia Munkholm, Professor Department of Gastroenterology, Herlev Hospital
Study Chair: Christian Jakobsen, MD, PhD Department of Pediatrics, Hvidovre Hospital
Study Chair: Lene Riis, MD, PhD Department of Pathology, Herlev Hospital
  More Information

No publications provided

Responsible Party: Katrine Carlsen, MD, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01860651     History of Changes
Other Study ID Numbers: YOUNG-WEB
Study First Received: May 20, 2013
Last Updated: April 11, 2014
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Hvidovre University Hospital:
Inflammatory Bowel Disease
Ulcerative Colitis
Crohn´s Disease
Children
Adolescence
E-health web-monitoring
Adherence
Disease activity
Fecal Calprotectin

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Intestinal Diseases
Colitis
Colitis, Ulcerative
Crohn Disease
Ulcer
Colonic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2014