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

Recruiting now · Not applicable

Conditions studied: Functional Abdominal Pain Disorders, Irritable Bowel Syndrome (IBS), Functional Dyspepsia, Abdominal Migraine

In brief

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.

Key facts

Study ID

NCT06665867

Run by

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

People needed

208

Starts

2024-06-01

Expected to finish

2025-11-30

Last updated by the study team

2024-10-30

Who can join

Age: 4 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• If no follow-up consultation is indicated
• If it is necessary that the follow-up consultations are face to face

Where it is running

• Amsterdam UMC, location AMC — Amsterdam, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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