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.
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
If no follow-up consultation is indicated
If it is necessary that the follow-up consultations are face to face
Parallel
Video consultation
Other interventionParticipants will have their follow-up consultation with the physician via video. The consultation takes place via the participant's/parent's own device.
Face-to-face consultation
Other interventionThe follow-up consultation with the physician will take place at the hospital.
Adequate relief
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.
Pain intensity
Number of children with a decrease of 30% of pain intensity after 12 weeks compared to baseline, measured on a Visual Analogue Scale (VAS) of 0-10. A score of 0 means no pain and a score of 10 means a lot of pain. The VAS-score is a mean score of 7 consecutive days. Children will be asked to fill in a diary for 7 days at baseline, after 6 weeks and after 12 weeks.
Pain frequency
Number of children with a decrease of 30% pain frequency per day after 12 weeks compared to baseline. Pain frequency will be recorded as number of hours of pain per day, as a mean of 7 consecutive days. Children will be asked to fill a diary for 7 days at baseline, after 6 weeks and after 12 weeks.
Healthcare experience
Both parents/guardians and children (if \> 8 years old) will be asked to complete the Patient Reported Experience Measure for Specialist Medical Care questionnaire after every consultation. The questionnaire consists of 7 questions that participants can answer using a 10-point Likert scale, where a score of 1 means 'No, not at all' and a score of 10 means 'Yes, completely'. The questionnaire also contains one question with a binary answer (yes/no).
Shared decision making (parents/guardians)
Parents/guardians will be asked to complete the CollaboRATE questionnaire after every consultation. The questionnaire consists of three questions regarding shared decision making tasks during consultation. Responses to each question range from 0 ("no effort was made") to 9 ("every effort was made").
Click on the lead sponsor to view all of their trials.
