Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2025-12-28 @ 2:14 PM
Study NCT ID:
NCT01838161
Status:
COMPLETED
Last Update Posted:
2019-05-07
First Post:
2013-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Adolescent Vaccination in Appalachian Kentucky
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': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 597}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-03', 'studyFirstSubmitDate': '2013-04-04', 'studyFirstSubmitQcDate': '2013-04-22', 'lastUpdatePostDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Part III - Site-based group randomized controlled trial design - Vaccination outcomes', 'timeFrame': '1 year', 'description': 'Community vaccination clinic sites in the intervention and control conditions will be matched on percentage of free/reduced school lunch and relevant demographics. Randomization will occur at the group and individual level. One site in each pair will be randomized to the enhanced video educational intervention condition (within this group individuals will be randomized to video vignettes + standard of care vaccine education or the standard of care vaccine education) or a standard of care (standard of care vaccine education) comparison group. The medical record review will allow us to examine behavior change (i.e., receipt of age-appropriate vaccinations) for each of the different vaccine types and their single or multi-dose outcomes.'}], 'primaryOutcomes': [{'measure': 'Part I - Parent Interviews', 'timeFrame': '1 year', 'description': 'Interview questions will focus on reticence to vaccinate children. Participants will be a convenience sample recruited through contacts in local public health departments, community nurses and the research study coordinators.'}], 'secondaryOutcomes': [{'measure': 'Part II - Intention to Vaccinate', 'timeFrame': '1 Year', 'description': 'The investigator will pilot the vaccination vignettes in a health department (clinical) setting with eligible parents of adolescents. The Investigator will then expose parents to vignette condition using the iPad, administer a pretest survey, the video vignette, and a post-test survey measuring intention to receive appropriate adolescent vaccines for their child as well as perceived message effectiveness (for the vignette).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['adolescents', 'immunizations'], 'conditions': ['Adolescent Immunization']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Cohen, E. L. and K. J. Head (2014).'}]}, 'descriptionModule': {'briefSummary': 'The proposed project develops a community and school-based intervention to enhance understanding of the importance all age-appropriate vaccinations, and uses an innovative, comprehensive approach (Project INSPIRE - Instilling Necessary Sickness Prevention with Immunizations Reaching Everyone) to ensure that all parents of adolescents are advised of all age-appropriate vaccines for sickness prevention. The investigator will develop a novel set of targeted video vignette persuasive informational decision aids (including target population representatives) to enhance lay understanding of recommended adolescent (or catch-up) vaccines. The Investigator will also partner with school districts to develop a replicable social marketing vaccination event program (Project INSPIRE) to encourage parents and teens to publicly vaccinate at community events and during drop-in school nursing clinic hours. The project will test the efficacy of the video-based health education intervention + standard of care to ideal standard of care (social marketing vaccination event program) approaches to immunize adolescents in this region.', 'detailedDescription': 'This is not an interventional study in which subject will be given a investigator drug or device.\n\nPart I of the INSPIRE intervention development will involve formative research interviews conducted with parents of adolescents. Interview questions will focus on reticence to vaccinate children. Participants will be a convenience sample recruited through contacts in local public health departments and community nurses recruited by flyer and the research study coordinators (UK study personnel). Interview sessions will be scheduled in advance and will take approximately 30 minutes.\n\nPart II of the INSPIRE intervention development will be evaluated in a small clinic-based pilot study using the same pre-test/post-test intervention design as in the planned (Part III) trial. For the pilot testing, the investigators will pilot the vaccination vignettes in a health department (clinical) setting with eligible parents of adolescents. Eligible parents who are coming in for non-acute care appointments will be asked by a research nurse to enroll in a research study. The Investigator will then administer a pretest survey, expose participants (parents) to vignette condition using the iPad in the clinic, and a post-test survey measuring intention to receive appropriate adolescent vaccines for their child as well as perceived message effectiveness (for the vignette). At the conclusion of the study, the research personnel administering the study will refer the adolescent to the clinic staff who will offer adolescent vaccines at the conclusion of the study (and/or a cue to schedule an appointment for the adolescent to visit the clinic) and will be able to examine actual behavior by receiving informed consent (from parents and adolescent) for limited medical record review (to track adolescent receipt of vaccinations). The Investigator will perform this pilot study in one Kentucky River Area District health department clinic with 30 parents. This method has been used to pilot past interventions, and it is expected that this allow us to correct for any problems in either the design of the survey assessment or the intervention. If needed, the investigator can tweak the intervention and re-pilot using the same procedures before the randomized controlled trial. This pilot test will also provide the advantage of assuring us that the intervention procedure can translate to the clinic setting. The Investigator has experience with this translation from our 1-2-3 Pap video intervention which the investigators began in social settings (recruiting people at school and other community events) and moved into the clinic setting for dissemination.\n\nPart III of the INSPIRE project will be evaluated in a site-based group randomized controlled trial design, with individual-level randomization also occurring within the intervention group. Community vaccination clinic and health education sites (staffed by local health department contracted personnel and project nurses) in the intervention and control conditions will be matched on percentage of free/reduced school lunch and relevant demographics. At the end of Year 1, one health site in each pair will be randomized to the enhanced video educational intervention (video vignettes + standard of care social marketing vaccine event) or a standard of care vaccination campaign (standard of care health department vaccine event) comparison group. Individuals in the intervention group randomized condition also will be randomized when recruitment occurs in non-school based locations. Assessments will be conducted using Automated iPad Audio Assisted Interviewing techniques at pretest, immediate post-test, and then medical record review at 1 month and 9 month follow-up points. The medical record review will entail examining the medical record for each adolescent vaccine received by the patient. Thus, the investigators will be able to examine behavior change (i.e., receipt of vaccination) for each of the different vaccine types and their single or multi-dose outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parents/guardians with legal custody of a minor child\n* Parents of children 11-18 years of age.\n\nExclusion Criteria:\n\n* Parents under the age of 18\n* Allergy to vaccinations\n* Parent has made an informed decision not to vaccinate their child'}, 'identificationModule': {'nctId': 'NCT01838161', 'acronym': 'INSPIRE', 'briefTitle': 'Improving Adolescent Vaccination in Appalachian Kentucky', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Project INSPIRE: Improving Adolescent Vaccination in Appalachian Kentucky', 'orgStudyIdInfo': {'id': '13-0026-P4S'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Part I', 'description': 'Interview questions will focus on reticence to vaccinate children.', 'interventionNames': ['Behavioral: Part I']}, {'type': 'EXPERIMENTAL', 'label': 'Part II', 'description': 'We will pilot the vaccination vignettes in a health department (clinical) setting with eligible parents of adolescents.\n\n* a pretest survey\n* the video vignette\n* and a post-test survey measuring intention to receive appropriate adolescent vaccines', 'interventionNames': ['Behavioral: Part II']}, {'type': 'EXPERIMENTAL', 'label': 'Part III', 'description': '* enhanced video educational intervention (video vignettes + standard of care vaccine event)\n* standard of care vaccination event', 'interventionNames': ['Behavioral: Part III']}], 'interventions': [{'name': 'Part II', 'type': 'BEHAVIORAL', 'description': 'Parents will be exposed to an educational video intervention if they are enrolled in this intervention condition.', 'armGroupLabels': ['Part II']}, {'name': 'Part III', 'type': 'BEHAVIORAL', 'otherNames': ['Video Education'], 'description': '•video educational', 'armGroupLabels': ['Part III']}, {'name': 'Part I', 'type': 'BEHAVIORAL', 'description': 'Parental Interviews', 'armGroupLabels': ['Part I']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40475', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'overallOfficials': [{'name': 'Elisia Cohen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, {'name': 'University of Kentucky', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}