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NCT Number: NCT06665867

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

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.

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Key information

Conditions

Functional Abdominal Pain Disorders Abdominal Migraine Brain Diseases Central Nervous System Diseases Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Functional Dyspepsia Gastrointestinal Diseases Headache Disorders Headache Disorders, Primary Intestinal Diseases Irritable Bowel Syndrome Irritable Bowel Syndrome (IBS) Migraine Disorders Nervous System Diseases

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amsterdam UMC, location AMC

Amsterdam, Netherlands

Location status: Recruiting

Location contact

M.M. Tabbers, Dr. PhD.

CONTACT

[email protected]

020 5668000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Video consultation

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

Other

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

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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).

  4. 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").

  5. 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").

  6. 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.

  7. 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.

  8. Number of no shows

    Time frame: 12 weeks

    Proportion of no shows

  9. 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.

  10. 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

  11. 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. Duration of consultations

    Time frame: 12 weeks

    Duration of consultations for both face to face consultations and video consultations

Study contacts

Contact information is provided by the study sponsor or research team.

A. de Geus, Bsc.

CONTACT

020 5668000

M.M. Tabbers, Dr. Phd.

CONTACT

[email protected]

020 5668000

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: VICO

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 30, 2024
Registry last updated
Oct 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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