NCT06665867 VICO-trial: Video Consultations in the Follow-up of Children With Functional Abdominal Pain Disorders
| NCT ID | NCT06665867 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Condition | Functional Abdominal Pain Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 208 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2025-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 208 participants in total. It began in 2024-06-01 with a primary completion date of 2025-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06665867 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 17 Years, studying Functional Abdominal Pain Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06665867 currently recruiting?
Yes, NCT06665867 is actively recruiting participants. Contact the research team at m.m.tabbers@amsterdamumc.nl for enrollment information.
Where is the NCT06665867 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT06665867 clinical trial?
NCT06665867 is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The trial plans to enroll 208 participants.