Functional Abdominal Pain DisordersVICONCT06665867
VICO-trial: Video Consultations in the Follow-up of Children With Functional Abdominal Pain Disorders
A study testing Video consultation and Face-to-face consultation in people with Functional Abdominal Pain Disorders and Irritable Bowel Syndrome (IBS), run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Functional Abdominal Pain Disorders, Irritable Bowel Syndrome (IBS), Functional Dyspepsia
- What is being tested?
- Video consultation and Face-to-face consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2024to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- If no follow-up consultation is indicated
- If it is necessary that the follow-up consultations are face to face
Trial locations and contacts
1 site in 1 country.
A. de Geus, Bsc. contact
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC, location AMC
Amsterdam
M.M. Tabbers, Dr. PhD., 020 5668000, m.m.tabbers@amsterdamumc.nl
About this study
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.
- Conditions
- Functional Abdominal Pain Disorders, Irritable Bowel Syndrome (IBS), Functional Dyspepsia, Abdominal Migraine
- Being tested
- Video consultation, Face-to-face consultation
- Keywords
- E-health, Video consultations, Children, Functional abdominal pain disorders
- Medical subject headings
- Irritable Bowel Syndrome, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Face-to-face consultationOther
The follow-up consultation with the physician will take place at the hospital.
| Study group | Role | What they receive |
|---|---|---|
| Video consultation | Experimental | These participants are randomized for video consultations. Participants will receive two follow-up consultations via video. Receives: 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. Receives: Other: Face-to-face consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 12 weeks
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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).
Measured: 12 weeks
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").
Measured: 12 weeks
Shared decision making (children)
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").
Measured: 12 weeks
Experience of patients and parents/guardians with video consultations
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.
Measured: 12 weeks
Experience of healthcare professionals with video consultations
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.
Measured: End inclusion phase (expected 1.5 years)
Number of no shows
Proportion of no shows
Measured: 12 weeks
Number of extra face to face consultations
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.
Measured: 12 weeks
Number of hours absent from school due to consultation
Number of hours children were absent from school due to the consultation
Measured: 12 weeks
Number of hours absent from work due to consultation
Number of work hours missed by parents/guardians due to the consultation
Measured: 12 weeks
Duration of consultations
Duration of consultations for both face to face consultations and video consultations
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start1 Jun 2024
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Abdominal Pain DisordersStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merit Monique Tabbers, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665867
- Sponsor's protocol ID
- 2024.0101
- Acronym
- VICO
- Status last verified
- Oct 2024
- First submitted
- 19 Jul 2024
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VICO-trial: Video Consultations in the Follow-up of Children With Functional Abdominal Pain Disorders
- ClinicalTrials.gov ID
- NCT06665867
- Acronym / sponsor ID
- VICO / 2024.0101
- Conditions
- Functional Abdominal Pain Disorders, Irritable Bowel Syndrome (IBS), Functional Dyspepsia, Abdominal Migraine
- Keywords
- E-health, Video consultations, Children, Functional abdominal pain disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 30 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video consultation | Experimental | Other: Video consultationThese participants are randomized for video consultations. Participants will receive two follow-up consultations via video. |
| Face-to-face consultation | Active comparator | Other: Face-to-face consultationThese participants are randomized for face-to-face consultations. Participants will receive two follow-up face-to-face consultations in the hospital. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- If no follow-up consultation is indicated
- If it is necessary that the follow-up consultations are face to face
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video consultationParticipants will have their follow-up consultation with the physician via video. The consultation takes place via the participant's/parent's own device. | Other | Video consultation |
| Face-to-face consultationThe follow-up consultation with the physician will take place at the hospital. | Other | Face-to-face consultation |
Primary outcome
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.
12 secondary outcomes
Pain intensity
Time frame: 12 weeks
Pain frequency
Time frame: 12 weeks
Healthcare experience
Time frame: 12 weeks
Shared decision making (parents/guardians)
Time frame: 12 weeks
Shared decision making (children)
Time frame: 12 weeks
Experience of patients and parents/guardians with video consultations
Time frame: 12 weeks
Experience of healthcare professionals with video consultations
Time frame: End inclusion phase (expected 1.5 years)
Number of no shows
Time frame: 12 weeks
Number of extra face to face consultations
Time frame: 12 weeks
Number of hours absent from school due to consultation
Time frame: 12 weeks
Number of hours absent from work due to consultation
Time frame: 12 weeks
Duration of consultations
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A. de Geus, Bsc. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video consultation and Face-to-face consultation in people with Functional Abdominal Pain Disorders and Irritable Bowel Syndrome (IBS), run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact M.M. Tabbers, Dr. Phd. (020 5668000, m.m.tabbers@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adequate relief (time frame: After 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2024.