StoMakker Mobile Application

NCT06065995 | Terminated DMC

• 1 other identifier: 2022.0505
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases; Anorectal Malformations; Spina Bifida; Ostomy

Keywords

Gamification; Mobile application

Outcome Measures

Primary Outcomes (1)

• 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 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

  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

  6 months follow-up

• Occurrence of any surgery related complications as specified by the clavien-dindo classification within 6 months of follow-up.

  6 months follow up

Study Arms (2)

Intervention

EXPERIMENTAL

Access to the mobile application

Device: StoMakker

Control group

NO INTERVENTION

Standard care, without access to the application

Interventions

StoMakker DEVICE

A mobile application that offers age dependent information, a peer support platform and a game

Intervention

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Academic Medical Centre

Amsterdam-Zuidoost, North Holland, 1105 AZ, Netherlands

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Anorectal Malformations; Spinal Dysraphism

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Digestive System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neural Tube Defects; Nervous System Malformations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Open-label randomized controlled trial

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: October 4, 2023
• Study Start: September 30, 2022
• Primary Completion: January 28, 2025
• Study Completion: January 28, 2025
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)