To examine if use of a web-based program for continuous disease monitoring (IBD-live) improves disease course, quality of life and cost-efficiency of care, as compared to usual care.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is the frequency of relapse at 12 months of follow-up. Relapse
is defined as a clinical activity score >10 points necessitating steroid
therapy, a 6 week course of exclusive enteral nutrition, aminosalicylate dose
escalation, or introduction of anti-TNF antibodies.
Secondary outcome
- Disease specific quality of life measured with the IMPACT-III questionnaire
- Cost-effectiveness will be evaluated from a societal perspective,
incorporating travel expenses and costs of parental absence from work, next to
direct medical costs of IBD care.
Background summary
To prevent clinical relapse in teenagers with inflammatory bowel disease (IBD)
there is a need to monitor disease activity continuously. Timely optimisation
of medical treatment may nip a preclinical relapse in the bud and change the
natural course of IBD. Traditionally, disease monitoring is done during
scheduled visits, but this is when most patients report full control. IBD care
could be more efficient if patients were seen at times of clinical need.
Study objective
To examine if use of a web-based program for continuous disease monitoring
(IBD-live) improves disease course, quality of life and cost-efficiency of
care, as compared to usual care.
Study design
Multicenter randomized trial comparing IBD-live with usual care.
Intervention
Teenagers assigned to IBD-live will use the flarometer -an automatic cumulation
of disease activity and fecal calprotectin (fCal)- to estimate probability of
relapse. In case of high risk treatment is intensified in accordance with
national guidelines; low risk means that maintenance therapy is unchanged; and
intermediate risk requires optimisation of drug adherence.
Study burden and risks
There is no additional risk in the control group. In the intervention group
scheduled doctor-patient encounters and blood drawings will be reduced to once
every 6 months. The 6-months interval between two phlebotomies may hinder early
recognition of thiopurine-related toxicity, although we expect to find a low
incidence of this adverse reaction among eligible participants. Patients from
both groups are instructed to contact the local IBD-team if they experience
relapse, or if at any time they want a consultation.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL43086.042.13 |