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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 17
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
Amsterdam UMC, location AMC
RECRUITING
Amsterdam
Contact Information
Primary
M.M. Tabbers, Dr. Phd.
m.m.tabbers@amsterdamumc.nl
020 5668000
Backup
A. de Geus, Bsc.
020 5668000
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2025-11-30
Participants
Target number of participants: 208
Treatments
Experimental: Video consultation
These participants are randomized for video consultations. Participants will receive two follow-up consultations via video.
Active_comparator: Face-to-face consultation
These participants are randomized for face-to-face consultations. Participants will receive two follow-up face-to-face consultations in the hospital.
Sponsors
Leads: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

This content was sourced from clinicaltrials.gov