Web-based home monitoring of disease activity and relapse risk

Completed

Conditions: Crohn's disease and ulcerative colitis
10017969

Registration Number: NL-OMON41416

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 180

Inclusion Criteria

age 10 to 19 years,
quiescent IBD for more than 3 months before study enrolment,
IBD diagnosed (according to the Porto criteria) more than 6 months before enrolment,
access to internet and weighing scale
knowledge of the Dutch language
adult caregiver who is willing to actively support participation

Exclusion Criteria

maintenance treatment with infliximab or adalimumab,
presence of ileostomy or ileoanal pouch,
any comorbidity at the time of enrolment that requires hospitalization or frequent blood sampling.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome is the frequency of relapse at 12 months of follow-up. Relapse<br /><br>is defined as a clinical activity score >10 points necessitating steroid<br /><br>therapy, a 6 week course of exclusive enteral nutrition, aminosalicylate dose<br /><br>escalation, or introduction of anti-TNF antibodies. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Disease specific quality of life measured with the IMPACT-III questionnaire<br /><br>- Cost-effectiveness will be evaluated from a societal perspective,<br /><br>incorporating travel expenses and costs of parental absence from work, next to<br /><br>direct medical costs of IBD care. </p><br>