VICO-trial: Video Consultations in the Follow-up of Children With Functional Abdominal Pain Disorders

NCT ID: NCT06665867

Last Updated: 2024-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Functional Abdominal Pain Disorders Irritable Bowel Syndrome (IBS) Functional Dyspepsia Abdominal Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Video consultation

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

Group Type EXPERIMENTAL

Video consultation

Intervention Type OTHER

Participants 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

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

Group Type ACTIVE_COMPARATOR

Face-to-face consultation

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Face-to-face consultation

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role lead

Responsible Party

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Merit Monique Tabbers

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Amsterdam UMC, location AMC

Amsterdam, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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M.M. Tabbers, Dr. Phd.

Role: CONTACT

020 5668000

A. de Geus, Bsc.

Role: CONTACT

020 5668000

Facility Contacts

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M.M. Tabbers, Dr. PhD.

Role: primary

020 5668000

Other Identifiers

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2024.0101

Identifier Type: -

Identifier Source: org_study_id

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