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

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

Status: Enrolling

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

Treatments: Other: Video consultation; Other: Face-to-face consultation

Study type: Interventional

Funder types: Other

Identifiers

NCT06665867

2024.0101

Details and patient eligibility

About

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.

Enrollment: 208 estimated patients

Sex: All

Ages: 4 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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208 participants in 2 patient groups

Video consultation

Experimental group

Description:

These participants are randomized for video consultations. Participants will receive two follow-up consultations via video.

Treatment:

Other: Video consultation

Face-to-face consultation

Active Comparator group

Description:

These participants are randomized for face-to-face consultations. Participants will receive two follow-up face-to-face consultations in the hospital.

Treatment:

Other: Face-to-face consultation