Inflammatory Bowel DiseasesStoMakkerNCT06065995
StoMakker Mobile Application
A study testing StoMakker in people with Inflammatory Bowel Diseases and Anorectal Malformations, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
The goal of this clinical trial is to investigate if access to the StoMakker application will significantly improve health-related quality of life in children receiving surgery resulting in an ileostomy, colostomy or continent urostomy. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Anorectal Malformations, Spina Bifida
- What is being tested?
- StoMakker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 30 Sep 2022to 28 Jan 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Individuals scheduled for ileostomy, colostomy or continent urostomy surgery
- Children aged between 6 and 18 years
- Possession of, or continous access to a smartphone or tablet operated with iOS 9 and up or Android 8.0 and up
- Access to email and internet
Who cannot join
- Incompetence of understanding the Dutch language
- Visual impairment, unless well corrected with visual aids
- Physical disabilities limiting the use of a mobile application
- Mental disabilities limiting the use of a mobile application, learning and filling in questionnaires
- Patients with pre-existing skin conditions such as pemphigus, para-pemphigus or psoriasis that may disturb or influence normal stoma care protocols
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Academic Medical Centre
Amsterdam-Zuidoost, North Holland, 1105 AZ
About this study
Official title: StoMakker: Improving the Quality of Life of Children Receiving an Ileostomy, Colostomy or Continent Urostomy by Offering Access to a Peer Support Platform, Age Dependent Information Provision and Games in a Smartphone Application
The goal of this clinical trial is to investigate if access to the StoMakker application will significantly improve health-related quality of life in children receiving surgery resulting in an ileostomy, colostomy or continent urostomy. The main question it aims to answer are:
- Does access to StoMakker improve health-related quality of life in children receiving surgery for an ostomy?
- Does access to StoMakker improve the anxiety and social functioning of children receiving surgery for an ostomy?
- Does access to StoMakker improve postoperative complications of children receiving surgery for an ostomy?
Participants will be asked to fill in several questionnaires around their surgery. The intervention group of the trial will be given access to the application "StoMakker". The control group of the trial will receive standard care.
Read the detailed description
Peer support, patient education and -guidance are of crucial importance for children undergoing surgery for a stoma. Current supportive care is either lacking or via paper folders, which is not a suitable strategy for supporting this vulnerable group of children.
The main objective of this prospective trial is to investigate whether access to a peer support platform, age-dependent information provision and games using a smartphone application increases self-reported health related quality of life (HRQOL).
Study population: Children aged between 6 and 18 years old who will receive an ileostomy, colostomy or continent urostomy, are eligible for inclusion. Participants must have access to a smartphone or tablet. Children who are unable to use a smartphone due to mental or physical disabilities will be excluded from the study
Patients and their parents/caregivers are obliged to give written informed consent before they are allowed to be enrolled in the study.
The design of the study is an open-label multicenter randomized controlled trial with a follow-up of 6 months. The intervention group will get access to the app. The control group will receive standard care. Measurement is done via questionnaires, which are send at specificic intervals based on the surgery date. Parents or caregivers will also receive several questionnaires at specific intervals based on the surgery date.
The primary outcome of this study is health-related quality of life. Secondary outcomes are postoperative outcomes, knowledge retention, patient satisfaction with the received care and self-efficacy
- Being tested
- StoMakker
- Keywords
- Gamification, Mobile application
- Medical subject headings
- Inflammatory Bowel Diseases, Anorectal Malformations, Spinal Dysraphism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StoMakkerDevice
A mobile application that offers age dependent information, a peer support platform and a game
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Access to the mobile application Receives: Device: StoMakker |
| Control group | No intervention | Standard care, without access to the application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in health-related quality of life of participants on the age specific 7 item PROMIS Pediatric Global Health scale (PGH-7) questionnaire at 6 months after surgery
The Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Global Health scale (PGH-7) is a validated self reported instrument for assessing general health. Scores range from 5 (low health-related quality of life) to 35 (high health-related quality of life). The questionnaire has been translated to dutch and validated in the Netherlands and dutch speaking Belgium
Change = 6 month score - baseline
Measured: 6 months follow-up
Secondary outcomes (3)
Change from baseline in anxiety of participants on the age specific 8 item PROMIS pediatric v2.0 Anxiety and Depressive Symptoms, the short form 8a questionnaire at 6 months follow-up
The Patient-Reported Outcomes Measurement Information System (PROMIS) pediatric item banks v2.0 Anxiety and Depressive Symptoms, the short forms 8a is a validated questionnaire. Scores range from 8 to 40 where a higher score indicates a higher level of anxiety
The questionnaire has been translated to dutch and validated in the Netherlands and dutch speaking Belgium
Change = 6 month score - baseline
Measured: 6 months follow-up
Change from baseline in social functioning of participants on the age specific PROMIS pediatric item bank peer relationships short form 8a at 6 months after surgery
The Patient-Reported Outcomes Measurement Information System (PROMIS) pediatric item banks v2.0 Peer relationships, the short forms 8a is a validated questionnaire. Scores range from 8 to 40 where a higher score indicates a higher level of social functioning
The questionnaire has been translated to dutch and validated in the Netherlands and dutch speaking Belgium
Change = 6 month score - baseline . Scores range from 8 (low social functioning) to 40 (high social functioning)
Measured: 6 months follow-up
Occurrence of any surgery related complications as specified by the clavien-dindo classification within 6 months of follow-up.
The Clavien Dindo Classification is used to rank the severity of a surgical complication. It is based on the type of therapy needed to correct the complication. The scale consists of several grades (Grade I, II, IIIa, IIIb, IVa, IVb and V). Grade I complications are usually mild but Grade II and higher complications are more significant. Examples include (but are not limited to): infections requiring antibiotics, blood transfusions or injury to abdominal or pelvic structures
Measured: 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start30 Sep 2022
- Primary completion28 Jan 2025
- Study completion28 Jan 2025
Why it stopped: participant inclusion rate could not be achieved timely
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marlies P. Schijven, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065995
- Sponsor's protocol ID
- 2022.0505
- Acronym
- StoMakker
- Status last verified
- Jan 2025
- First submitted
- 18 Jul 2023
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- StoMakker: Improving the Quality of Life of Children Receiving an Ileostomy, Colostomy or Continent Urostomy by Offering Access to a Peer Support Platform, Age Dependent Information Provision and Games in a Smartphone Application
- ClinicalTrials.gov ID
- NCT06065995
- Acronym / sponsor ID
- StoMakker / 2022.0505
- Keywords
- Gamification, Mobile application
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: participant inclusion rate could not be achieved timely
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 28 Jan 2025 (actual)
- Study completion
- 28 Jan 2025 (actual)
- First posted
- 4 Oct 2023 (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 clinical trial is to investigate if access to the StoMakker application will significantly improve health-related quality of life in children receiving surgery resulting in an ileostomy, colostomy or continent urostomy. The main question it aims to answer are:
- Does access to StoMakker improve health-related quality of life in children receiving surgery for an ostomy?
- Does access to StoMakker improve the anxiety and social functioning of children receiving surgery for an ostomy?
- Does access to StoMakker improve postoperative complications of children receiving surgery for an ostomy?
Participants will be asked to fill in several questionnaires around their surgery. The intervention group of the trial will be given access to the application "StoMakker". The control group of the trial will receive standard care.
Detailed description
Peer support, patient education and -guidance are of crucial importance for children undergoing surgery for a stoma. Current supportive care is either lacking or via paper folders, which is not a suitable strategy for supporting this vulnerable group of children.
The main objective of this prospective trial is to investigate whether access to a peer support platform, age-dependent information provision and games using a smartphone application increases self-reported health related quality of life (HRQOL).
Study population: Children aged between 6 and 18 years old who will receive an ileostomy, colostomy or continent urostomy, are eligible for inclusion. Participants must have access to a smartphone or tablet. Children who are unable to use a smartphone due to mental or physical disabilities will be excluded from the study
Patients and their parents/caregivers are obliged to give written informed consent before they are allowed to be enrolled in the study.
The design of the study is an open-label multicenter randomized controlled trial with a follow-up of 6 months. The intervention group will get access to the app. The control group will receive standard care. Measurement is done via questionnaires, which are send at specificic intervals based on the surgery date. Parents or caregivers will also receive several questionnaires at specific intervals based on the surgery date.
The primary outcome of this study is health-related quality of life. Secondary outcomes are postoperative outcomes, knowledge retention, patient satisfaction with the received care and self-efficacy
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: StoMakkerAccess to the mobile application |
| Control group | No intervention | –Standard care, without access to the application |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Individuals scheduled for ileostomy, colostomy or continent urostomy surgery
- Children aged between 6 and 18 years
- Possession of, or continous access to a smartphone or tablet operated with iOS 9 and up or Android 8.0 and up
- Access to email and internet
Key exclusion criteria (5 listed)
- Incompetence of understanding the Dutch language
- Visual impairment, unless well corrected with visual aids
- Physical disabilities limiting the use of a mobile application
- Mental disabilities limiting the use of a mobile application, learning and filling in questionnaires
- Patients with pre-existing skin conditions such as pemphigus, para-pemphigus or psoriasis that may disturb or influence normal stoma care protocols
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 |
|---|---|---|
| StoMakkerA mobile application that offers age dependent information, a peer support platform and a game | Device | Intervention |
Primary outcome
Change from baseline in health-related quality of life of participants on the age specific 7 item PROMIS Pediatric Global Health scale (PGH-7) questionnaire at 6 months after surgery
Time frame: 6 months follow-up
The Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Global Health scale (PGH-7) is a validated self reported instrument for assessing general health. Scores range from 5 (low health-related quality of life) to 35 (high health-related quality of life). The questionnaire has been translated to dutch and validated in the Netherlands and dutch speaking Belgium Change = 6 month score - baseline
3 secondary outcomes
Change from baseline in anxiety of participants on the age specific 8 item PROMIS pediatric v2.0 Anxiety and Depressive Symptoms, the short form 8a questionnaire at 6 months follow-up
Time frame: 6 months follow-up
Change from baseline in social functioning of participants on the age specific PROMIS pediatric item bank peer relationships short form 8a at 6 months after surgery
Time frame: 6 months follow-up
Occurrence of any surgery related complications as specified by the clavien-dindo classification within 6 months of follow-up.
Time frame: 6 months follow up
Results and safety
The study was stopped early (reason given: participant inclusion rate could not be achieved timely). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing StoMakker in people with Inflammatory Bowel Diseases and Anorectal Malformations, 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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 30 Jan 2025. 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?
The study was stopped early (reason given: participant inclusion rate could not be achieved timely). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in health-related quality of life of participants on the age specific 7 item PROMIS Pediatric Global Health scale (PGH-7) questionnaire at 6 months after surgery (time frame: 6 months follow-up). 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 Jan 2025.