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

October 29, 2024 updated by: Merit Monique Tabbers, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

208

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: A. de Geus, Bsc.
  • Phone Number: 020 5668000

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Video consultation
These participants are randomized for video consultations. Participants will receive two follow-up consultations via video.
Other: 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.
Active Comparator: 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.
Other: Face-to-face consultation
The follow-up consultation with the physician will take place at the hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
After 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: 12 weeks
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.
12 weeks
Pain frequency
Time Frame: 12 weeks
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.
12 weeks
Healthcare experience
Time Frame: 12 weeks
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).
12 weeks
Shared decision making (parents/guardians)
Time Frame: 12 weeks
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").
12 weeks
Shared decision making (children)
Time Frame: 12 weeks
Children (if > 8 years old) will be asked to fill in 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").
12 weeks
Experience of patients and parents/guardians with video consultations
Time Frame: 12 weeks
Both parents/guardians and children (if > 8 years old) will be asked to fill in a questionnaire regarding their experience with the video consultation after every consultation.
12 weeks
Experience of healthcare professionals with video consultations
Time Frame: End inclusion phase (expected 1.5 years)
Upon completion of the inclusion phase of the trial (expected 1.5 years from its start), all participating physicians will complete a questionnaire about their experience with video consultations.
End inclusion phase (expected 1.5 years)
Number of no shows
Time Frame: 12 weeks
Proportion of no shows
12 weeks
Number of extra face to face consultations
Time Frame: 12 weeks
Number of face to face consultations related to FAPD during the 12 week trial period, as extra to the two per protocol follow-up consultations. Participants will be asked a question in their questionnaire whether they went to the hospital (e.g. emergency department or extra consultation with their treating physician) for FAPD related complaints in the time between the two plannend consultations.
12 weeks
Number of hours absent from school due to consultation
Time Frame: 12 weeks
Number of hours children were absent from school due to the consultation
12 weeks
Number of hours absent from work due to consultation
Time Frame: 12 weeks
Number of work hours missed by parents/guardians due to the consultation
12 weeks
Duration of consultations
Time Frame: 12 weeks
Duration of consultations for both face to face consultations and video consultations
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

July 19, 2024

First Submitted That Met QC Criteria

October 29, 2024

First Posted (Actual)

October 30, 2024

Study Record Updates

Last Update Posted (Actual)

October 30, 2024

Last Update Submitted That Met QC Criteria

October 29, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024.0101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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