StoMakker Mobile Application

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status

Terminated

Conditions

Spina Bifida

Ostomy

Inflammatory Bowel Diseases

Anorectal Malformations

Treatments

Device: StoMakker

Study type

Interventional

Funder types

Other

Identifiers

NCT06065995

2022.0505

Details and patient eligibility

About

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.

Full 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

Enrollment

30 patients

Sex

All

Ages

6 to 18 years old

Volunteers

No Healthy Volunteers

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