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

Condition(s) studied

Investigational drug(s) / intervention(s)

Video consultation: Participants will have their follow-up consultation with the physician via video. The consultation takes place via the participant's/parent's own device.

Face-to-face consultation: The follow-up consultation with the physician will take place at the hospital.

Study summary

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

Primary outcome measure(s)

• Adequate relief — After 12 weeks
  Proportion of participants reporting adequate relief. Adequate relief is a patient-reported outcome. Participants will be asked at 6 weeks and 12 weeks whether they have adequate relief of their Functional Abdominal Pain Disorder related complaints using a binary outcome (yes/no). Participants will complete a diary for a week and participants will be asked about adequate relief in the diary on day 7.

Trial sites (1)

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