NCT06665867

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 30, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

October 30, 2024

Status Verified

October 1, 2024

Enrollment Period

1.5 years

First QC Date

July 19, 2024

Last Update Submit

October 29, 2024

Conditions

Functional Abdominal Pain DisordersIrritable Bowel Syndrome (IBS)Functional DyspepsiaAbdominal Migraine

Keywords

E-healthVideo consultationsChildrenFunctional abdominal pain disorders

Outcome Measures

Primary Outcomes (1)

  • 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.

    After 12 weeks

Secondary Outcomes (12)

  • Pain intensity

    12 weeks

  • Pain frequency

    12 weeks

  • Healthcare experience

    12 weeks

  • Shared decision making (parents/guardians)

    12 weeks

  • Shared decision making (children)

    12 weeks

  • +7 more secondary outcomes

Study Arms (2)

Video consultation

EXPERIMENTAL

These participants are randomized for video consultations. Participants will receive two follow-up consultations via video.

Other: Video consultation

Face-to-face consultation

ACTIVE COMPARATOR

These participants are randomized for face-to-face consultations. Participants will receive two follow-up face-to-face consultations in the hospital.

Other: Face-to-face consultation

Interventions

Video consultationOTHER

Participants will have their follow-up consultation with the physician via video. The consultation takes place via the participant's/parent's own device.

Video consultation
Face-to-face consultationOTHER

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

Face-to-face consultation

Eligibility Criteria

Age4 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • If no follow-up consultation is indicated
  • If it is necessary that the follow-up consultations are face to face

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam UMC, location AMC

Amsterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Irritable Bowel SyndromeMigraine Disorders

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

M.M. Tabbers, Dr. Phd.

CONTACT

020 5668000m.m.tabbers@amsterdamumc.nl

A. de Geus, Bsc.

CONTACT

020 5668000

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

July 19, 2024

First Posted

October 30, 2024

Study Start

June 1, 2024

Primary Completion

November 30, 2025

Study Completion

November 30, 2025

Last Updated

October 30, 2024

Record last verified: 2024-10

Locations

NL(1)