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

NCT06665867 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2024-10-30

No results posted yet for this study

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.

Conditions

  • Functional Abdominal Pain Disorders
  • Irritable Bowel Syndrome (IBS)
  • Functional Dyspepsia
  • Abdominal Migraine

Interventions

OTHER

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.

OTHER

Face-to-face consultation

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

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2025-11-30
Completion
2025-11-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06665867 on ClinicalTrials.gov