RecruitingNot ApplicableNCT06665867

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


Sponsor

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

Enrollment

208 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 4 YearsMax Age: 17 Years

Inclusion Criteria3

  • 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 Criteria2

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

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Interventions

OTHERVideo 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.

OTHERFace-to-face consultation

The follow-up consultation with the physician will take place at the hospital.


Locations(1)

Amsterdam UMC, location AMC

Amsterdam, Netherlands

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NCT06665867


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