Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2025-12-27 @ 9:53 PM
Study NCT ID:
NCT06065995
Status:
TERMINATED
Last Update Posted:
2025-01-30
First Post:
2023-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
StoMakker Mobile Application
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
participant inclusion rate could not be achieved timely
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
StoMakker
Brief 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. 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.
* 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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: