VICO-trial: Video Consultations in the Follow-up of Children With Functional Abdominal Pain Disorders
Recruiting · NCT06665867 · Interventional (participants receive a specific treatment) · Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The goal of this non-inferiority randomized controlled multi-center trial is to investigate the use of video consultations in the follow-up care of children aged 4 - 18 years old with functional abdominal pain disorders (FAPDs). Video consultations will be compared to face-to-face consultations. Clinical outcomes and patients' and parents' healthcare experience will be compared between both groups. Primary outcome is adequate relief after 12 weeks: the hypothesis is that video consultations are not inferior to face-to-face consultations regarding clinical outcomes and that adequate relief will be the same for both groups. Participants and/or parents will be asked to complete a diary for 1 week and a questionnaire after every consultation: at baseline, after 6 weeks and after 12 weeks.
Who can take part
Inclusion criteria
- Children aged 4 years to 17 years
- Meeting the Rome IV criteria for one of the four types of Functional Abdominal Pain Disorders (FAPD's): functional dyspepsia, irritable bowel syndrome, abdominal migraine, functional abdominal pain - not otherwise specified.
- Being able to conduct a video consultation
Exclusion criteria
- If no follow-up consultation is indicated
- If it is necessary that the follow-up consultations are face to face
Where it is running
1 location listed.
- Amsterdam UMC, location AMC - Amsterdam, Netherlands