Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT07025135
Brief Summary:
This randomized, double-blind clinical trial evaluates the effectiveness of use of a mobile health application in supporting the treatment of functional constipation in children aged 4 to 18 years. Participants are randomly assigned ( with en-bloc randomization) to either an intervention group using an interactive app with symptom tracking, reminders, and games or a control group using equivalent, but printed materials. The primary outcome is the improvement in constipation symptoms after 3 months with follow-up after 6 months (+/- 30 days) after enrollment. Secondary outcomes include achieving regular bowel movements. The study aims to determine whether digital tools can enhance treatment adherence and clinical outcomes in pediatric functional constipation.
Detailed Description:
Functional constipation is a common pediatric disorder that significantly affects the quality of life of children and their families. Despite the availability of evidence-based guidelines such as the Rome IV criteria and the ESPGHAN/NASPGHAN (European Society for Paediatric Gastroenterology, Hepatology and Nutrition/ North American Society for Paediatric Gastroenterology, Hepatology and Nutrition recommendations, treatment adherence remains a major challenge, often leading to suboptimal outcomes and chronic symptoms.
This randomized, double-blind, parallel-group clinical trial investigates the efficacy of a mobile health application designed to support the treatment of functional constipation in children. The study is conducted among children aged 4 to 18 years who meet the Rome IV diagnostic criteria for functional constipation. Participants are randomly allocated in a 1:1 ratio into two groups: an intervention group receiving standard care supplemented with an interactive mobile app, and a control group receiving standard care with a printed version of recommendations.
The interactive mobile app includes features aimed at increasing engagement and adherence, such as daily symptom tracking, medication and hydration reminders, educational content, diet guidance, and rewards to motivate participation. The printed materials are equivalent to app regarding information.
This trial aims to determine whether a digital intervention can meaningfully enhance treatment adherence and improve clinical outcomes in pediatric functional constipation, and potentially serve as a scalable tool for supporting families in managing this common chronic condition.
The primary endpoint is the improvement in constipation symptoms over 3 months and 6 months follow-up, assessed by measuring quality of life (measured using the PedsQL Gastrointestinal Module). Secondary outcome is the improvement (bowel movement frequency and stool consistency using the Bristol Stool Form Scale).
Data collection: Symptoms tracking - PedsQL Gastrointestinal Module, bowel movements, water intake, macrogol intake
\*Mobile App Features:
Daily symptom tracking
Medication reminders
Diet and fluid intake tips
Games and reward system
Control: Identical interface without interactive features
Intervention scheme:
Visit 1 (enrolment, 0):
medical history, physical examination interpretation of laboratory findings (coeliac disease, vitamin D deficiency, hypercalcemia, hypothyroidism), which would exclude patient from study app presentation or printed materials introduction PedsQL Gastrointestinal Module fill-up
Visit 2 (after 1 month, 1)
medical history, physical examination counseling PedsQL Gastrointestinal Module fill-up and comparison of results from previous visit
Visit 3 (after another 1 month, 2)
medical history, physical examination PedsQL Gastrointestinal Module fill-up and comparison of results from previous visit
Visit 4 (after another 1 month, 3)
medical history, physical examination counseling PedsQL Gastrointestinal Module fill-up and comparison of results from previous visit
Visit 5 ( follow-up after 6 month of study, 6) medical history, physical examination counseling, program ending and final remarks PedsQL Gastrointestinal Module fill-up and comparison of results from previous visit
Study:
NCT07025135
Study Brief:
Protocol Section:
NCT07025135