Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-01-02 @ 1:10 AM
Study NCT ID:
NCT07025135
Status:
COMPLETED
Last Update Posted:
2025-06-17
First Post:
2025-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effectiveness of a Mobile Application in the Treatment of Children With Functional Constipation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-26', 'size': 1557061, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-06-06T13:39', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-09', 'studyFirstSubmitDate': '2025-05-30', 'studyFirstSubmitQcDate': '2025-06-09', 'lastUpdatePostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'improvement of symptoms', 'timeFrame': '6 month +/- 30 days', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Achieving regularity of bowel movements', 'timeFrame': '6 months +/-30 days', 'description': 'Number of participants with regular bowel movement (more than 2 bowel movements/week)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['functional constipation', 'pediatrics', 'mobile app'], 'conditions': ['Constipation - Functional']}, 'referencesModule': {'references': [{'pmid': '41366315', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis 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.\n\nThe 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.\n\nThis 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.\n\nThe 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).\n\nData collection: Symptoms tracking - PedsQL Gastrointestinal Module, bowel movements, water intake, macrogol intake\n\n\\*Mobile App Features:\n\nDaily symptom tracking\n\nMedication reminders\n\nDiet and fluid intake tips\n\nGames and reward system\n\nControl: Identical interface without interactive features\n\nIntervention scheme:\n\nVisit 1 (enrolment, 0):\n\nmedical 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\n\nVisit 2 (after 1 month, 1)\n\nmedical history, physical examination counseling PedsQL Gastrointestinal Module fill-up and comparison of results from previous visit\n\nVisit 3 (after another 1 month, 2)\n\nmedical history, physical examination PedsQL Gastrointestinal Module fill-up and comparison of results from previous visit\n\nVisit 4 (after another 1 month, 3)\n\nmedical history, physical examination counseling PedsQL Gastrointestinal Module fill-up and comparison of results from previous visit\n\nVisit 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 4-18,\n* meeting Rome Criteria IV of functional constipation\n\nExclusion Criteria:\n\n* organic causes of constipation\n* comorbidities'}, 'identificationModule': {'nctId': 'NCT07025135', 'briefTitle': 'Evaluation of the Effectiveness of a Mobile Application in the Treatment of Children With Functional Constipation', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Gdansk'}, 'officialTitle': 'Evaluation of the Effectiveness of a Mobile Application in the Treatment of Children With Functional Constipation', 'orgStudyIdInfo': {'id': 'NKBBN/920/2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patient-caregiver dyad using mobile app', 'description': 'Patient-caregiver dyad receives standard care (optimal macrogol treatment) plus access to dedicated mobile app', 'interventionNames': ['Behavioral: comparison between use of mobile app']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'patient-caregiver dyad using paper recommendation', 'description': 'Patient-caregiver dyad receives standard care (optimal macrogol treatment) plus a non-interactive, educational-only printed version of recommendations.', 'interventionNames': ['Behavioral: Patient-caregiver dyad using printed recommendations']}], 'interventions': [{'name': 'comparison between use of mobile app', 'type': 'BEHAVIORAL', 'description': 'Patient-caregiver dyad receive standard care (optimal macrogol treatment) plus a mobile app featuring symptom tracking, medication reminders, dietary tips, and gamification elements.', 'armGroupLabels': ['patient-caregiver dyad using mobile app']}, {'name': 'Patient-caregiver dyad using printed recommendations', 'type': 'BEHAVIORAL', 'description': 'Patient-caregiver dyad receives standard care ( optimal macrogol treatment) plus a non-interactive, educational-only printed version of recommendations.', 'armGroupLabels': ['patient-caregiver dyad using paper recommendation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80-803', 'city': 'Gdansk', 'state': 'Pomeranian Voivodeship', 'country': 'Poland', 'facility': 'Department and Clinic of Pediatrics, Gastroenterology, Allergology and Pediatric Nutrition of Medical University of Gdansk', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'ipdSharing': 'YES', 'description': 'anyone contacting the authors will be assessed and data will be given to researchers/public authorities', 'accessCriteria': 'anyone contacting the authors will be assessed and data will be given to researchers/public authorities'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Gdansk', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}