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

NCT01860651 | Completed Results DMC

• 1 other identifier: YOUNG-WEB
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Disease; Ulcerative Colitis; Crohn´s Disease

Keywords

Inflammatory Bowel Disease; Ulcerative Colitis; Crohn´s Disease; Children; Adolescence; E-health web-monitoring; Adherence; Disease activity; Fecal Calprotectin

Outcome Measures

Primary Outcomes (1)

• Medical Adherence

  Participants (group 1, medication adm. at home): Medicine Adherence Report Scale (MARS): range 5-25 points. Higher scores mean a better outcome. In the below Outcome Measure Data Table the mean data for each group (web and control) summarized from the whole study periode are presented.

  Prospective, each third month, up to 2 years

Secondary Outcomes (5)

• Number of Participants With Step up in Medical Intensity

  The first event during participation (2 years). (events were prospecitvely registered)

• Surgery

  The first event during participation (2 years). (events were prospecitvely registered)

• Absence From School

  Prospective, each third month, - disease activity each month(project A) or week(project B), in 2 years

• Contact to the Hospital

  Prospective, each third month, - disease activity each month(project A) or week(project B), in 2 years

• Number of Weeks Between Treatment

  Prospective, each third month, - disease activity each month(project A) or week(project B), in 2 years

Study Arms (2)

Web-monitoring

ACTIVE COMPARATOR

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

Control

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

Interventions

Web-monitoring 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.

Web-monitoring

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• Insufficient Danish language skills
• Lack of intellectual capacity
• Growth retardation

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• University of Copenhagen: collaborator

Study Sites (1)

Department of Pediatrics, Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

Related Publications (1)

• 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.

  PMID: 28169974 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Limitations and Caveats

The main limitation is the relatively few participants that were all sourced from one center.

Results Point of Contact

• Title: Dr. Katrine Carlsen
• Organization: Hvidovre University Hospital

katrinec@gmail.com

26180513

Study Officials

• Katrine Carlsen, MD

  Department of Pediatrics, Hvidovre Hospital

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 20, 2013
• First Posted: May 23, 2013
• Study Start: September 1, 2013
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: March 1, 2019
• Results First Posted: February 15, 2019

Record last verified: 2018-08

Locations

DK (1)