Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-02-24 @ 3:52 AM
Study NCT ID:
NCT03910933
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-22
First Post:
2019-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electronic KIDCLOT Interactive Thrombosis/Thrombophilia Education; A Quality Assurance Initiative
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 248}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-19', 'studyFirstSubmitDate': '2019-04-08', 'studyFirstSubmitQcDate': '2019-04-08', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time in therapeutic Range', 'timeFrame': '18 months', 'description': 'Time INRs are within range'}, {'measure': 'Health care provider time associated with warfarin teaching', 'timeFrame': 'enrolment, 6 months and 18 months', 'description': 'Providers will measure and report the additional time spent providing patient teaching for warfarin management'}], 'primaryOutcomes': [{'measure': 'KIDCLOT What is an Anticoagulant Quiz1', 'timeFrame': 'enrolment', 'description': 'Quiz to assess patient learning of important concepts related to anticoagulants'}, {'measure': 'KIDCLOT What is an Anticoagulant Quiz1', 'timeFrame': '6 months and 18 months', 'description': 'Quiz to assess change in patient knowledge of important concepts related to anticoagulants'}, {'measure': 'Kidclot Warfarin Quiz 2', 'timeFrame': 'enrolment', 'description': 'Quiz to assess patient learning of important concepts related to warfarin'}, {'measure': 'Kidclot Warfarin Quiz 2', 'timeFrame': '6 months and 18 months', 'description': 'Quiz to assess patient learning of important concepts related to warfarin'}, {'measure': 'KIdclot INR testing Quiz 3', 'timeFrame': 'enrolment', 'description': 'Quiz to assess patient learning of important concepts related to INR testing'}, {'measure': 'KIdclot INR testing Quiz 3', 'timeFrame': '6 and 18 months', 'description': 'Quiz to assess change in patient knowledge of important concepts related to INR testing'}, {'measure': 'Kidclot safety on an anticoagulant Quiz 4', 'timeFrame': 'enrolment', 'description': 'Quiz to assess patient learning of important concepts related to patient safety on an anticoagulant'}, {'measure': 'Kidclot safety on an anticoagulant Quiz 4', 'timeFrame': '6 months and 18 months', 'description': 'Quiz to assess change in patient knowledge of important concepts related to patient safety on an anticoagulant'}, {'measure': 'Kidclot Home INR testing Quiz 5', 'timeFrame': 'enrolment', 'description': 'Quiz to assess patient learning of important concepts related to home INR testing'}, {'measure': 'Kidclot Home INR testing Quiz 5', 'timeFrame': '6 and 18 months', 'description': 'Quiz to assess change in patient knowledge of of important concepts related to home INR testing'}, {'measure': 'Kidclot Warfarin Self Management Quiz 6', 'timeFrame': '6 months', 'description': 'Quiz to assess patient learning of important concepts related to Warfarin Self Management'}, {'measure': 'Kidclot Warfarin Self Management Quiz 6', 'timeFrame': '18 months', 'description': 'Quiz to assess change in patient knowledge of of important concepts related to Warfarin Self Management'}], 'secondaryOutcomes': [{'measure': 'Patient preference', 'timeFrame': 'enrolment', 'description': 'Questionnaire'}, {'measure': 'Stress Around Learning Score STAI-1', 'timeFrame': 'enrolment', 'description': 'Survey to Assess patient stress around learning about warfarin and its management using the on-line modules. Measure of Calm.- Total score out of 40 with higher score indicates low stress and a positive outcome'}, {'measure': 'Stress Around Learning Score STAI-1', 'timeFrame': 'enrolment', 'description': 'Survey to Assess patient stress around learning about warfarin and its management using the on-line modules. Total score out of 40. Measure of Worry- Total score out of 40 with lower score indicates low stress indicating a positive outcome'}, {'measure': 'Pediatric Anticoagulation Quality of Life', 'timeFrame': '6', 'description': 'Quality of life score to assess impact of warfarin therapy on health related quality of life. Lower score indicates low impact. Score is a percentage'}, {'measure': 'Pediatric Anticoagulation Quality of Life', 'timeFrame': '18 months', 'description': 'Quality of life score to assess any change in impact of warfarin therapy on health related quality of life. Lower score indicates low impact. Score is a percentage'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Warfarin', 'Child'], 'conditions': ['Health Literacy', 'Anticoagulation']}, 'descriptionModule': {'briefSummary': 'Effective patient education improves health literacy and engagement thus improving long-term health outcomes. Health literacy is imperative to make informed health decisions and relies on the ability to obtain, process and understand health information; and is the cornerstone of safe health management. It is necessary to evaluate educational initiatives to determine their effectiveness in knowledge translation.\n\nA more effective way to provide patient education is to utilize media technology. Current education styles do not teach patients in the best way as they are not consistent with how people of all ages currently learn (through technology). In addition, patient teaching most commonly occurs during highly stressful times like hospital visits with new diagnoses. Current patient educational methods are costly given the amount of health provider time required.\n\nElectronic KITE teaching modules are infographic visual representations that present information quickly and clearly, integrating words and graphics to tell a story to reveal information. Infographic presentations are tools which facilitate self-directed learning with understandable, accessible information presented in an engaging way with an aim to enhance learning for children and their families. Patients are able to learn at a pace consistent with their learning style to facilitate knowledge development and health literacy.', 'detailedDescription': 'A more effective way to provide patient education is to utilize media technology. Current education styles do not teach patients in the best way as they are not consistent with how people of all ages currently learn (through technology). In addition, patienteaching most commonly occurs during highly stressful times like hospital visits with new diagnoses. Current patient educational methods are costly given the amount of health provider time required.\n\nElectronic KITE teaching modules are infographic visual representations that have been developed to provide patient teaching related to warfarin and its management.\n\nHow much patients have learned will be assessed using the KIDCLOT validated knowledge quizzes. Children 8 years and older to have cognitive capacity will complete the quizzes if able. Caregivers will complete all quizzes linked with the modules they have completed.\n\nPatients may be enrolled into the appropriate cohort based on the health provider decision for management.\n\n1. Warfarin international normalized ratio (INR) testing\n2. Warfarin with home INR testing\n3. Warfarin transition from home INR testing to warfarin self management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'English speaking children and their caregivers who initiate or require ongoing anticoaogulant therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric patients and their caregivers who are receiving treatment with anticoagulant therapy.\n\nExclusion Criteria:\n\n* Non-english speaking patients.'}, 'identificationModule': {'nctId': 'NCT03910933', 'acronym': 'eKITE', 'briefTitle': 'Electronic KIDCLOT Interactive Thrombosis/Thrombophilia Education; A Quality Assurance Initiative', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'EKITE: Electronic KIDCLOT Interactive Thrombosis/Thrombophilia Education; A Quality Assurance Initiative', 'orgStudyIdInfo': {'id': 'Pro00074672'}}, 'armsInterventionsModule': {'interventions': [{'name': 'elearning patient information', 'type': 'OTHER', 'description': 'The videos will standardize patient teaching about anticoagulants, warfarin, INR testing, and warfarin safety for Patient Self-Testing, and Patient Self-Management. eKITE, will provide a user-friendly interface to provide health education about anticoagulation. eKITE will teach concepts to the patient, facilitate sustained patient knowledge (6 month evaluation), reduce stress associated with learning, actively engage patients in their anticoagulant management (preference, satisfaction and knowledge).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Ann & Robert H Lurie Children's Hospital", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '021115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "St. Louis Children's Hospital", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children'Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': "Stollery Children's Hospital", 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'K1H 8L1', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': "Children's Hospital of Easter Ontario", 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Mary Bauman, MN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Stollery Children's Hospital, University of Alberta"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}