Clinical trial NCT06665867: VICO-trial: Video Consultations in the Follow-up of Children With Functional Abdominal Pain Disorders
Official title: VICO-trial: Video Consultations in the Follow-up of Children With Functional Abdominal Pain Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Functional Abdominal Pain Disorders
Irritable Bowel Syndrome (IBS)
Functional Dyspepsia
Abdominal Migraine
Keywords: E-health
Video consultations
Children
Functional abdominal pain disorders
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2024-10-30
Enrollment: 208
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Adequate relief
timeFrame: After 12 weeks
Secondary outcomes:
measure: Pain intensity
timeFrame: 12 weeks
measure: Pain frequency
timeFrame: 12 weeks
measure: Healthcare experience
timeFrame: 12 weeks
measure: Shared decision making (parents/guardians)
timeFrame: 12 weeks
measure: Shared decision making (children)
timeFrame: 12 weeks
measure: Experience of patients and parents/guardians with video consultations
timeFrame: 12 weeks
measure: Experience of healthcare professionals with video consultations
timeFrame: End inclusion phase (expected 1.5 years)
measure: Number of no shows
timeFrame: 12 weeks
measure: Number of extra face to face consultations
timeFrame: 12 weeks
measure: Number of hours absent from school due to consultation
timeFrame: 12 weeks
measure: Number of hours absent from work due to consultation
timeFrame: 12 weeks
measure: Duration of consultations
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location AMC
Study officials:
References: