Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
30 participants
INTERVENTIONAL
2022-09-30
2025-01-28
Brief Summary
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* 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.
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Intervention
Access to the mobile application
StoMakker
A mobile application that offers age dependent information, a peer support platform and a game
Control group
Standard care, without access to the application
No interventions assigned to this group
Interventions
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StoMakker
A mobile application that offers age dependent information, a peer support platform and a game
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Years
18 Years
ALL
No
Sponsors
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
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Marlies P. Schijven
Principal Investigator
Locations
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Academic Medical Centre
Amsterdam-Zuidoost, North Holland, Netherlands
Countries
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Other Identifiers
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2022.0505
Identifier Type: -
Identifier Source: org_study_id
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