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NCT06665867 | RECRUITING | Functional Abdominal Pain Disorders


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

Academic Medical Center - University of Amsterdam (AMC-UvA)

Information provided by (Responsible Party):

Merit Monique Tabbers

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.

Condition or disease

Functional Abdominal Pain Disorders

Irritable Bowel Syndrome (IBS)

Functional Dyspepsia

Abdominal Migraine

Intervention/treatment

Video consultation

Face-to-face consultation

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 208 participants
Masking : NONE
Primary Purpose : OTHER
Official Title : VICO-trial: Video Consultations in the Follow-up of Children With Functional Abdominal Pain Disorders
Actual Study Start Date : 2024-06-01
Estimated Primary Completion Date : 2025-11-30
Estimated Study Completion Date : 2025-11-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 4 Years to 17 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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

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

Location Details

NCT06665867


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Locations


RECRUITING

Netherlands,

Amsterdam UMC, location AMC

Amsterdam, Netherlands,

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