N/A
Completed N=103
Web-based Monitoring in Children and Adolescents With Inflammatory Bowel Disease
Source: ClinicalTrials.gov NCT01860651 ↗Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcomePrimary: Medical Adherence — 23.3; 23.3 units on a scale — p=0.22
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Medical Adherence |
23.3; 23.3 | 0.22 |
| SECONDARY Number of Participants With Step up in Medical Intensity |
10; 12 | — |
| SECONDARY Surgery |
0; 0 | — |
| SECONDARY Absence From School |
1.6; 16.5 | — |
| SECONDARY Contact to the Hospital |
2; 8 | — |
| SECONDARY Number of Weeks Between Treatment |
9.5; 6.9 | — |
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
Data sourced from ClinicalTrials.gov (NCT01860651). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.