Evaluation of the Effectiveness of a Mobile Application in the Treatment of Children With Functional Constipation

NCT ID: NCT07025135

Last Updated: 2025-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-05
• Study Completion Date: 2024-06-30

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

Conditions

Constipation - Functional

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

patient-caregiver dyad using mobile app

Patient-caregiver dyad receives standard care (optimal macrogol treatment) plus access to dedicated mobile app

Group Type: EXPERIMENTAL

comparison between use of mobile app

Intervention Type: BEHAVIORAL

Patient-caregiver dyad receive standard care (optimal macrogol treatment) plus a mobile app featuring symptom tracking, medication reminders, dietary tips, and gamification elements.

patient-caregiver dyad using paper recommendation

Patient-caregiver dyad receives standard care (optimal macrogol treatment) plus a non-interactive, educational-only printed version of recommendations.

Group Type: ACTIVE_COMPARATOR

Patient-caregiver dyad using printed recommendations

Intervention Type: BEHAVIORAL

Patient-caregiver dyad receives standard care ( optimal macrogol treatment) plus a non-interactive, educational-only printed version of recommendations.

Interventions

comparison between use of mobile app

Patient-caregiver dyad receive standard care (optimal macrogol treatment) plus a mobile app featuring symptom tracking, medication reminders, dietary tips, and gamification elements.

Intervention Type: BEHAVIORAL

Patient-caregiver dyad using printed recommendations

Patient-caregiver dyad receives standard care ( optimal macrogol treatment) plus a non-interactive, educational-only printed version of recommendations.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• age 4-18,
• meeting Rome Criteria IV of functional constipation

Exclusion Criteria

• organic causes of constipation
• comorbidities

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Gdansk

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department and Clinic of Pediatrics, Gastroenterology, Allergology and Pediatric Nutrition of Medical University of Gdansk

Gdansk, Pomeranian Voivodeship, Poland

Countries

Poland

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

NKBBN/920/2021

Identifier Type: -

Identifier Source: org_study_id