Inflammatory Bowel Diseases Clinical Trial
— StoMakkerOfficial 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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 31, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 18 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Academic Medical Centre | Amsterdam-Zuidoost | Noord-Holland |
Lead Sponsor | Collaborator |
---|---|
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
6 months follow-up | |
Secondary | 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 |
6 months follow-up | |
Secondary | 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) |
6 months follow-up | |
Secondary | 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 | 6 months follow up |
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