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

NCT07025135 | Completed

• 1 other identifier: NKBBN/920/2021
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation - Functional

Keywords

functional constipation; pediatrics; mobile app

Outcome Measures

Primary Outcomes (1)

• improvement of symptoms

  Decreased severity (measured by Likert scale, where 0 means never and 5 means almost always) of symptoms measured by PedsQL (Pediatric Quality of Life) - Gastrointestinal Module

  6 month +/- 30 days

Secondary Outcomes (1)

• Achieving regularity of bowel movements

  6 months +/-30 days

Study Arms (2)

patient-caregiver dyad using mobile app

EXPERIMENTAL

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

Behavioral: comparison between use of mobile app

patient-caregiver dyad using paper recommendation

ACTIVE COMPARATOR

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

Behavioral: Patient-caregiver dyad using printed recommendations

Interventions

comparison between use of mobile app 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 mobile app

Patient-caregiver dyad using printed recommendations BEHAVIORAL

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

patient-caregiver dyad using paper recommendation

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• organic causes of constipation
• comorbidities

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

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

Gdansk, Pomeranian Voivodeship, 80-803, Poland

Location

Related Publications (1)

• Leszkowicz J, Nazar W, Wysokinska-Zakrzewska K, Zdun-Ryzewska A, Czadek-Asner P, Dettlaff-Dunowska M, Plata-Nazar K, Szlagatys-Sidorkiewicz A. Mobile app improves treatment of functional constipation in children: a randomized single-blind study. BMC Pediatr. 2025 Dec 9;25(1):980. doi: 10.1186/s12887-025-06385-y.

  PMID: 41366315 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 17, 2025
• Study Start: February 5, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: June 17, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Access Criteria: anyone contacting the authors will be assessed and data will be given to researchers/public authorities

Locations

PL (1)