NCT06665867

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 208 (estimated)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 4 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Functional Abdominal Pain Disorders
• Irritable Bowel Syndrome (IBS)
• Functional Dyspepsia
• Abdominal Migraine

Interventions

Type	Name	Description
OTHER	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.
OTHER	Face-to-face consultation	The follow-up consultation with the physician will take place at the hospital.

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-11-30
• Completion: 2025-11-30
• First posted: 2024-10-30
• Last updated: 2024-10-30

Locations

1 site across 1 country: Netherlands