VICO-trial: Video Consultations in the Follow-up of Children With Functional Abdominal Pain Disorders
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 208
- Locations
- 1
- Primary Endpoint
- Adequate relief
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 4 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Video consultation
These participants are randomized for video consultations. Participants will receive two follow-up consultations via video.
Intervention: Video consultation (Other)
Face-to-face consultation
These participants are randomized for face-to-face consultations. Participants will receive two follow-up face-to-face consultations in the hospital.
Intervention: Face-to-face consultation (Other)
Outcomes
Primary Outcomes
Adequate relief
Time Frame: After 12 weeks
Proportion of participants reporting adequate relief. Adequate relief is a patient-reported outcome. Participants will be asked at 6 weeks and 12 weeks whether they have adequate relief of their Functional Abdominal Pain Disorder related complaints using a binary outcome (yes/no). Participants will complete a diary for a week and participants will be asked about adequate relief in the diary on day 7.
Secondary Outcomes
- Pain frequency(12 weeks)
- Shared decision making (parents/guardians)(12 weeks)
- Pain intensity(12 weeks)
- Healthcare experience(12 weeks)
- Shared decision making (children)(12 weeks)
- Experience of patients and parents/guardians with video consultations(12 weeks)
- Experience of healthcare professionals with video consultations(End inclusion phase (expected 1.5 years))
- Number of extra face to face consultations(12 weeks)
- Number of hours absent from school due to consultation(12 weeks)
- Number of hours absent from work due to consultation(12 weeks)
- Duration of consultations(12 weeks)
- Number of no shows(12 weeks)
Investigators
Merit Monique Tabbers
Dr
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)