Overview

This trial is active, not recruiting.

Conditions inflammatory bowel disease, ulcerative colitis, crohn´s disease
Treatment web-monitoring
Sponsor Hvidovre University Hospital
Collaborator University of Copenhagen
Start date September 2013
End date July 2017
Trial size 88 participants
Trial identifier NCT01860651, YOUNG-WEB

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Active Comparator)
There is two arms for intervention: 1) Patients in treatment with medicine administrated at home and 2) patients in treatment with biologicals.
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)
Patients in treatment with medicine administrated at home: routine outpatient controls, four times a year. Patients in treatment with biologicals: retrospective routine treatment algorithm

Primary Outcomes

Measure
Adherence
time frame: Prospective, each third month in 2 years

Secondary Outcomes

Measure
Disease activity
time frame: Prospective, each third month, - disease activity each month(project A) or week(project B), in 2 years
Fecal Calprotectin
time frame: Prospective, each third month, - disease activity each month(project A) or week(project B), in 2 years
Steroid dose
time frame: Prospective, each third month, - disease activity each month(project A) or week(project B), in 2 years
Surgery rate
time frame: Prospective, each third month, - disease activity each month(project A) or week(project B), in 2 years
Absence from school
time frame: Prospective, each third month, - disease activity each month(project A) or week(project B), in 2 years
Medical treatment
time frame: Prospective, each third month, - disease activity each month(project A) or week(project B), in 2 years
Contact to the hospital
time frame: Prospective, each third month, - disease activity each month(project A) or week(project B), in 2 years
Frequency of biological treatment
time frame: Prospective, each third month, - disease activity each month(project A) or week(project B), in 2 years

Eligibility Criteria

Male or female participants from 10 years up to 17 years old.

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

Additional Information

Official title Patient Empowerment: Web-based Monitoring in Children and Adolescents With Inflammatory Bowel Disease for Better Quality of Treatment
Principal investigator Katrine Carlsen, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Hvidovre University Hospital.