Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-26 @ 4:15 PM
Study NCT ID:
NCT01773759
Status:
COMPLETED
Last Update Posted:
2017-04-13
First Post:
2013-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunization Protection in Child Care (IPiCC) Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-12', 'studyFirstSubmitDate': '2013-01-13', 'studyFirstSubmitQcDate': '2013-01-17', 'lastUpdatePostDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Children enrolled in child care program up-to-date for required immunizations', 'timeFrame': 'Up to 2 years', 'description': 'Proportion of children up-to-date for all state required childhood immunizations in the Utah State Immunization Information System (USIIS)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Immunizations', 'Child care', 'School health promotion'], 'conditions': ['Up-to-date Immunization Status for Children in Child Care']}, 'descriptionModule': {'briefSummary': "Ensuring that all children are fully immunized against vaccine-preventable diseases is a critical public health issue. Child care programs are critical targets for efforts to increase the proportion of infants and young children who are fully immunized. The primary objective of this proposal is to rigorously examine current state, local government, and child care providers' efforts and barriers to ensuring that all enrolled children are up-to-date for required immunizations and to evaluate strategies to improve immunization coverage in child care programs.", 'detailedDescription': "Specific Aim 1 will describe Utah state and local government activities to ensure compliance of child care programs with state immunization requirements and identify government's barriers to ensuring compliance.\n\nSpecific Aim 2 will describe child care program staffs' knowledge, attitudes, and activities related to ensuring that all children are up-to-date for required immunizations and identify program barriers to ensuring up-to-date status.\n\nSpecific Aim 3 will evaluate at least 3 strategies to ensure that all children enrolled in child care programs are up-to-date for required immunizations. Aims 1 and 2 will guide the design of these strategies. Specific strategies proposed for Aim 3 are to: 1) design and pilot test an intervention to increase child care program use of the Utah State Immunization Information System (USIIS), 2) design an online immunization education module and conduct a pilot randomized controlled trial to determine whether use of the module changes child care providers' knowledge, attitudes, and activities and increases the proportion of children who are up-to-date for required immunizations; and 3) conduct a pilot randomized controlled trial to determine whether a quality improvement intervention implemented in child care programs increases the proportion of children who are up-to-date for required immunizations."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nChild care programs not currently registered to use the Utah State Immunization Information System (USIIS) in Utah counties with acceptable USIIS coverage will be included.\n\nExclusion Criteria:\n\nChild care programs in Utah counties with lower than acceptable USIIS coverage will be excluded.'}, 'identificationModule': {'nctId': 'NCT01773759', 'acronym': 'IPiCC', 'briefTitle': 'Immunization Protection in Child Care (IPiCC) Project', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Strategies to Improve Vaccination Coverage in Child Care Centers and Preschools', 'orgStudyIdInfo': {'id': 'IP000500'}, 'secondaryIdInfos': [{'id': 'RFA-IP-11-006', 'type': 'OTHER_GRANT', 'domain': 'Centers for Disease Control and Prevention'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention child care programs', 'description': 'Intervention child care programs will receive immunization outreach and education.', 'interventionNames': ['Behavioral: Intervention child care programs']}, {'type': 'NO_INTERVENTION', 'label': 'Control child care programs', 'description': 'Control programs will receive no more than usual training regarding childhood immunization requirements.'}], 'interventions': [{'name': 'Intervention child care programs', 'type': 'BEHAVIORAL', 'description': 'Interventions will be designed based on findings from Aims 1 and 2, will include outreach and education, and may include on-site demonstration and USIIS training or peer tutoring.', 'armGroupLabels': ['Intervention child care programs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84108', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Julie H. Shakib, DO, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}, {'name': 'Utah Department of Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Julie H. Shakib, DO, MPH', 'investigatorFullName': 'Julie Shakib', 'investigatorAffiliation': 'University of Utah'}}}}