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

NCT ID: NCT01860651

Last Updated: 2019-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2017-05-31

Brief 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.

Conditions

Inflammatory Bowel Disease; Ulcerative Colitis; Crohn´s Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Web-monitoring

There is two arms for intervention:

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

Group Type: ACTIVE_COMPARATOR

Web-monitoring

Intervention Type: BEHAVIORAL

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.

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Copenhagen

OTHER

Sponsor Role: collaborator

Hvidovre University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Katrine Carlsen, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katrine Carlsen, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Pediatrics, Hvidovre Hospital

Vibeke Wewer, MD, PhD

Role: STUDY_CHAIR

Department of Pediatrics, Hvidovre Hospital

Pia Munkholm, Professor

Role: STUDY_CHAIR

Department of Gastroenterology, Herlev Hospital

Christian Jakobsen, MD, PhD

Role: STUDY_CHAIR

Department of Pediatrics, Hvidovre Hospital

Lene Riis, MD, PhD

Role: STUDY_CHAIR

Department of Pathology, Herlev Hospital

Locations

Department of Pediatrics, Hvidovre Hospital

Hvidovre, , Denmark

Countries

Denmark

References

Carlsen K, Jakobsen C, Kallemose T, Paerregaard A, Riis LB, Munkholm P, Wewer V. F-calprotectin and Blood Markers Correlate to Quality of Life in Pediatric Inflammatory Bowel Disease. J Pediatr Gastroenterol Nutr. 2017 Nov;65(5):539-545. doi: 10.1097/MPG.0000000000001540.

Reference Type: DERIVED

PMID: 28169974 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

YOUNG-WEB

Identifier Type: -

Identifier Source: org_study_id