Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2025-12-27 @ 9:53 PM
Study NCT ID:
NCT06065995
Status:
TERMINATED
Last Update Posted:
2025-01-30
First Post:
2023-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
StoMakker Mobile Application
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D000071056', 'term': 'Anorectal Malformations'}, {'id': 'D016135', 'term': 'Spinal Dysraphism'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D004065', 'term': 'Digestive System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D009436', 'term': 'Neural Tube Defects'}, {'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Open-label randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'whyStopped': 'participant inclusion rate could not be achieved timely', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2023-07-18', 'studyFirstSubmitQcDate': '2023-10-02', 'lastUpdatePostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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', 'timeFrame': '6 months follow-up', 'description': '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\n\nChange = 6 month score - baseline'}], 'secondaryOutcomes': [{'measure': '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', 'timeFrame': '6 months follow-up', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS) pediatric item banks v2.0 Anxiety and Depressive Symptoms, the short forms 8a is a validated questionnaire. Scores range from 8 to 40 where a higher score indicates a higher level of anxiety\n\nThe questionnaire has been translated to dutch and validated in the Netherlands and dutch speaking Belgium\n\nChange = 6 month score - baseline'}, {'measure': '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', 'timeFrame': '6 months follow-up', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS) pediatric item banks v2.0 Peer relationships, the short forms 8a is a validated questionnaire. Scores range from 8 to 40 where a higher score indicates a higher level of social functioning\n\nThe questionnaire has been translated to dutch and validated in the Netherlands and dutch speaking Belgium\n\nChange = 6 month score - baseline . Scores range from 8 (low social functioning) to 40 (high social functioning)'}, {'measure': 'Occurrence of any surgery related complications as specified by the clavien-dindo classification within 6 months of follow-up.', 'timeFrame': '6 months follow up', 'description': 'The Clavien Dindo Classification is used to rank the severity of a surgical complication. It is based on the type of therapy needed to correct the complication. The scale consists of several grades (Grade I, II, IIIa, IIIb, IVa, IVb and V). Grade I complications are usually mild but Grade II and higher complications are more significant. Examples include (but are not limited to): infections requiring antibiotics, blood transfusions or injury to abdominal or pelvic structures'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gamification', 'Mobile application'], 'conditions': ['Inflammatory Bowel Diseases', 'Anorectal Malformations', 'Spina Bifida', 'Ostomy']}, 'descriptionModule': {'briefSummary': '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:\n\n* Does access to StoMakker improve health-related quality of life in children receiving surgery for an ostomy?\n* Does access to StoMakker improve the anxiety and social functioning of children receiving surgery for an ostomy?\n* Does access to StoMakker improve postoperative complications of children receiving surgery for an ostomy?\n\nParticipants 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.', 'detailedDescription': 'Peer support, patient education and -guidance are of crucial importance for children undergoing surgery for a stoma. Current supportive care is either lacking or via paper folders, which is not a suitable strategy for supporting this vulnerable group of children.\n\nThe main objective of this prospective trial is to investigate whether access to a peer support platform, age-dependent information provision and games using a smartphone application increases self-reported health related quality of life (HRQOL).\n\nStudy population: Children aged between 6 and 18 years old who will receive an ileostomy, colostomy or continent urostomy, are eligible for inclusion. Participants must have access to a smartphone or tablet. Children who are unable to use a smartphone due to mental or physical disabilities will be excluded from the study\n\nPatients and their parents/caregivers are obliged to give written informed consent before they are allowed to be enrolled in the study.\n\nThe design of the study is an open-label multicenter randomized controlled trial with a follow-up of 6 months. The intervention group will get access to the app. The control group will receive standard care. Measurement is done via questionnaires, which are send at specificic intervals based on the surgery date. Parents or caregivers will also receive several questionnaires at specific intervals based on the surgery date.\n\nThe primary outcome of this study is health-related quality of life. Secondary outcomes are postoperative outcomes, knowledge retention, patient satisfaction with the received care and self-efficacy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals scheduled for ileostomy, colostomy or continent urostomy surgery\n* Children aged between 6 and 18 years\n* Possession of, or continous access to a smartphone or tablet operated with iOS 9 and up or Android 8.0 and up\n* Access to email and internet\n\nExclusion Criteria:\n\n* Incompetence of understanding the Dutch language\n* Visual impairment, unless well corrected with visual aids\n* Physical disabilities limiting the use of a mobile application\n* Mental disabilities limiting the use of a mobile application, learning and filling in questionnaires\n* Patients with pre-existing skin conditions such as pemphigus, para-pemphigus or psoriasis that may disturb or influence normal stoma care protocols'}, 'identificationModule': {'nctId': 'NCT06065995', 'acronym': 'StoMakker', 'briefTitle': 'StoMakker Mobile Application', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'StoMakker: Improving the Quality of Life of Children Receiving an Ileostomy, Colostomy or Continent Urostomy by Offering Access to a Peer Support Platform, Age Dependent Information Provision and Games in a Smartphone Application', 'orgStudyIdInfo': {'id': '2022.0505'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Access to the mobile application', 'interventionNames': ['Device: StoMakker']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Standard care, without access to the application'}], 'interventions': [{'name': 'StoMakker', 'type': 'DEVICE', 'description': 'A mobile application that offers age dependent information, a peer support platform and a game', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1105 AZ', 'city': 'Amsterdam-Zuidoost', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Academic Medical Centre', 'geoPoint': {'lat': 52.3075, 'lon': 4.97222}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Marlies P. Schijven', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}