VICO-trial: Video Consultations in the Follow-up of Children With Functional Abdominal Pain Disorders

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-17
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

If no follow-up consultation is indicated

If it is necessary that the follow-up consultations are face to face

Trial design

Treatments tested in this trial

  • Video consultation
  • Face-to-face consultation

Treatment groups

208 Participants
are divided into 2 treatment groups