Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2026-02-26 @ 4:30 PM
Study NCT ID:
NCT03290157
Status:
UNKNOWN
Last Update Posted:
2019-02-05
First Post:
2017-09-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improvement of Colonoscopy Preparation by Using a SPA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-05-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-04', 'studyFirstSubmitDate': '2017-09-15', 'studyFirstSubmitQcDate': '2017-09-20', 'lastUpdatePostDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Bowel preparation', 'timeFrame': 'During colonoscopy procedure', 'description': 'Measurement of bowel cleanliness by Boston Bowel preparation Scale (BBPS) with special regard on percentage of insufficient results of bowel preparation'}], 'secondaryOutcomes': [{'measure': 'Adenoma detection rate', 'timeFrame': 'histological analysis after colonoscopy up to 10 days (d10)', 'description': 'Rate of adenoma detected and resected during colonoscopy'}, {'measure': 'Acceptance of patients towards bowel preparation procedure', 'timeFrame': 'at colonoscopy appointment (day 0)', 'description': 'Measurement of patient satisfaction and acceptance with colonoscopy preparation procedure rated by numeric Rating scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colonoscopy', 'preparation', 'new media', 'SPA', 'APP'], 'conditions': ['Colonoscopy Preparation']}, 'referencesModule': {'references': [{'pmid': '32240835', 'type': 'DERIVED', 'citation': 'Walter B, Frank R, Ludwig L, Dikopoulos N, Mayr M, Neu B, Mayer B, Hann A, Meier B, Caca K, Seufferlein T, Meining A. Smartphone Application to Reinforce Education Increases High-Quality Preparation for Colorectal Cancer Screening Colonoscopies in a Randomized Trial. Clin Gastroenterol Hepatol. 2021 Feb;19(2):331-338.e5. doi: 10.1016/j.cgh.2020.03.051. Epub 2020 Mar 30.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the impact of a SPA on Quality of bowel preparation for colonoscopy. Half of the patients receive regular paper based information on colonoscopy preparation (control), while the other half will use an additional SPA for colonoscopy preparation (coloprAPP).', 'detailedDescription': 'Preparation for colonoscopy is perceived as a major impediment to participate in CRC screening colonoscopy. Hence, inadequate bowel preparation is reported in up to 25% of all patients undergoing colonoscopy.\n\nAlthough the quality of bowel preparation is influenced by various factors, it largely depends on patient´s compliance regarding instructions on purgatives and diet. Therefore reinforced education and guidance is a valuable tool to improve bowel preparation.\n\nA rapidly increasing number of individuals worldwide use smartphones in their daily life. Application of this new technology into patient education could facilitate and empower the patient guidance. In this study patients either receive regular information on colonoscopy preparation (paper-based) or download a SPA for reinforced reminding of the steps of colonoscopy preparation. Objective of this study is to measure the impact of a SPA on quality of bowel preparation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* smartphone\n* outpatient appointment for colonoscopy\n* CRC Screening, surveillance\n* \\<ASA 3\n\nExclusion Criteria:\n\n* no smartphone\n* \\>ASA 3 (no possibility for outpatient colonoscopy)'}, 'identificationModule': {'nctId': 'NCT03290157', 'acronym': 'ColoprAPP', 'briefTitle': 'Improvement of Colonoscopy Preparation by Using a SPA', 'organization': {'class': 'OTHER', 'fullName': 'University of Ulm'}, 'officialTitle': 'Evaluation of Improvement of Colonoscopy Preparation by Using a SPA', 'orgStudyIdInfo': {'id': 'ColoprAPP Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Regular colonoscopy preparation paper based information provided'}, {'type': 'OTHER', 'label': 'ColoprAPP group', 'description': 'Regular colonoscopy preparation paper based information provided plus usage of a downloaded SPA (ColoprAPP) as a reminder system for colonoscopy preparation', 'interventionNames': ['Device: ColoprAPP']}], 'interventions': [{'name': 'ColoprAPP', 'type': 'DEVICE', 'description': 'Additional downloaded SPA for reminding the crucial steps of colonoscopy preparation', 'armGroupLabels': ['ColoprAPP group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dornstadt', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Leopold Ludwig, MD', 'role': 'CONTACT'}], 'facility': 'Gastroenterologische Praxis Dornstadt', 'geoPoint': {'lat': 48.46697, 'lon': 9.94434}}, {'city': 'Landshut', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Bruno Neu, MD', 'role': 'CONTACT'}], 'facility': 'Krankenhaus Landshut-Achdorf', 'geoPoint': {'lat': 48.52961, 'lon': 12.16179}}, {'city': 'Ludwigsburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Benjamin Meier, MD', 'role': 'CONTACT'}], 'facility': 'Krankenhaus Ludwigsburg', 'geoPoint': {'lat': 48.89731, 'lon': 9.19161}}, {'city': 'Ulm', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Benjamin M Walter, MD', 'role': 'CONTACT', 'email': 'Benjamin.walter@uniklinik-ulm.de', 'phone': '0049-731-500-44818'}], 'facility': 'Universitätsklinikum Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}], 'centralContacts': [{'name': 'Benjamin M Walter, MD', 'role': 'CONTACT', 'email': 'Benjamin.walter@uniklinik-ulm.de', 'phone': '0049-731-500-44818'}], 'overallOfficials': [{'name': 'Benjamin M Walter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Ulm'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ulm', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Endoscopy department', 'investigatorFullName': 'Alexander Meining', 'investigatorAffiliation': 'University of Ulm'}}}}