VICO-trial: Video Consultations in the Follow-up of Children With Functional Abdominal Pain Disorders
NCT ID: NCT06665867
Last Updated: 2024-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
208 participants
INTERVENTIONAL
2024-06-01
2025-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Video consultation
These participants are randomized for video consultations. Participants will receive two follow-up consultations via video.
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.
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.
Face-to-face consultation
The follow-up consultation with the physician will take place at the hospital.
Interventions
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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.
Face-to-face consultation
The follow-up consultation with the physician will take place at the hospital.
Eligibility Criteria
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Inclusion Criteria
* 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 it is necessary that the follow-up consultations are face to face
4 Years
17 Years
ALL
No
Sponsors
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
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Merit Monique Tabbers
Dr
Locations
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Amsterdam UMC, location AMC
Amsterdam, , Netherlands
Countries
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Central Contacts
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A. de Geus, Bsc.
Role: CONTACT
Facility Contacts
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Other Identifiers
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2024.0101
Identifier Type: -
Identifier Source: org_study_id
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