VICO-trial: Video Consultations in the Follow-up of Children With Functional Abdominal Pain Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Video consultation, Face-to-face consultation.
- Who it may be relevant to
- Registry conditions: Functional Abdominal Pain Disorders, Irritable Bowel Syndrome (IBS), Functional Dyspepsia, Abdominal Migraine. Basic parameters: 4 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Primary outcome measures
- Adequate relief [Time frame: After 12 weeks]
Secondary outcome measures (12)
- Pain intensity [Time frame: 12 weeks]
- Pain frequency [Time frame: 12 weeks]
- Healthcare experience [Time frame: 12 weeks]
- Shared decision making (parents/guardians) [Time frame: 12 weeks]
- Shared decision making (children) [Time frame: 12 weeks]
- Experience of patients and parents/guardians with video consultations [Time frame: 12 weeks]
- Experience of healthcare professionals with video consultations [Time frame: End inclusion phase (expected 1.5 years)]
- Number of no shows [Time frame: 12 weeks]
- Number of extra face to face consultations [Time frame: 12 weeks]
- Number of hours absent from school due to consultation [Time frame: 12 weeks]
- Number of hours absent from work due to consultation [Time frame: 12 weeks]
- Duration of consultations [Time frame: 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Netherlands · 1 center
- Amsterdam UMC, location AMC — Amsterdam
Identifiers
NCT: NCT06665867 · 2024.0101