Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-28 @ 9:00 AM
Study NCT ID:
NCT05087303
Status:
RECRUITING
Last Update Posted:
2025-07-01
First Post:
2021-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telemedicine for Children With Sickle Cell Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2021-06-15', 'studyFirstSubmitQcDate': '2021-10-08', 'lastUpdatePostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measuring adherence to appointment in sickle cell care.', 'timeFrame': '1 year', 'description': 'Failed appointments in Electronic Medical Record - no more than one failed appointment during pilot year.'}, {'measure': 'Measuring adherence to lab draws in sickle cell care.', 'timeFrame': '6 months', 'description': 'Adherence to lab draws - a minimum of one complete blood count per six months.'}, {'measure': 'Measuring healthcare utilization pre and post telemedicine participation.', 'timeFrame': '1 year', 'description': 'Will determine the frequency of 1) vasoocclusive pain episode; 2) acute chest syndrome; 3) Emergency department visits; 4) hospitalizations. This data will be collected through chart abstraction from Electronic Medical Record one year prior to study entry and one year on study.'}, {'measure': 'Measuring collaboration of primary care provider and subspecialty care provider.', 'timeFrame': '1 year', 'description': 'Documentation of Primary Care Provider communication of visits in the electronic medical record at least 70% of the time.'}, {'measure': 'Provider Feedback', 'timeFrame': '1 year', 'description': 'Telemedicine Acceptance Questionnaire (TAQ) - will be given to all providers participating in telemedicine visits after every telemedicine visit. 0-5 Likert scale'}, {'measure': 'Caregiver feedback', 'timeFrame': '1 year', 'description': 'Telemedicine satisfaction survey (TESS) - administered to caregivers following each telemedicine visit. 0-5 Likert scale'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anemia, Sickle Cell']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn more about how the use of two different types of telemedicine (distance medical care) can address barriers to receiving comprehensive sickle cell care, and whether care can be improved. Aim 1: Adapt two telemedicine models (i.e., hub-and-spoke; direct-to-consumer) for use with children with SCD using caregiver input from our preliminary K12 work. Aim 2: Demonstrate the feasibility of the telemedicine models developed in Aim 1 as the models undergo successive stakeholder refinement during use in actual clinical care. Aim 3: Evaluate the effectiveness of the refined models from Aim 2 in a pre/post study by assessing (a) process of care measures, (b) provider satisfaction, (c) caregiver/patient-centered outcomes, and (d) clinical outcomes and healthcare utilization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Caregivers must be 18 years or older, who have children between 0 to 21 years old with a diagnosis of Sickle Cell Disease and receive care at the Riley Hospital for Children Comprehensive Sickle Cell Disease clinic.\n* Adolescent patients 16 years and older are also able to participate in interviews/surveys.\n* The family must be willing to receive their care using the telemedicine model available to them based on the location of their primary residence.\n* TeleSCD model participants must live within 1 hour of the pre-identified telemedicine sites, while VirtualSCD model participants must live within the city limits of the pre-identified area.\n\nExclusion Criteria:\n\n* If a patient receives chronic transfusion therapy, they will not be eligible to participate, as our telemedicine models will not support this.'}, 'identificationModule': {'nctId': 'NCT05087303', 'briefTitle': 'Telemedicine for Children With Sickle Cell Disease', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Telemedicine for Pediatric Sickle Cell Patients in Medically Underserved Areas', 'orgStudyIdInfo': {'id': '2101344406'}, 'secondaryIdInfos': [{'id': '1K23HL143162-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1K23HL143162-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hub and Spoke', 'interventionNames': ['Other: Types of Telemedicine Delivery Models']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Direct to Consumer', 'interventionNames': ['Other: Types of Telemedicine Delivery Models']}], 'interventions': [{'name': 'Types of Telemedicine Delivery Models', 'type': 'OTHER', 'description': 'Each arm delivers standard sickle cell care using a different model based on patient location.', 'armGroupLabels': ['Direct to Consumer', 'Hub and Spoke']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Seethal Jacob, MD', 'role': 'CONTACT', 'email': 'seejacob@iu.edu', 'phone': '317-278-9662'}], 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'centralContacts': [{'name': 'Seethal Jacob, MD', 'role': 'CONTACT', 'email': 'seejacob@iu.edu', 'phone': '317-278-9662'}], 'overallOfficials': [{'name': 'Seethal Jacob, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatrics', 'investigatorFullName': 'Seethal Jacob, MD, MS', 'investigatorAffiliation': 'Indiana University'}}}}