Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-28 @ 10:38 PM
Study NCT ID:
NCT05571657
Status:
UNKNOWN
Last Update Posted:
2022-10-13
First Post:
2022-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COVID-19 Booster Dose Reminder/Recall for Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-09-27', 'releaseDate': '2022-11-29'}, {'resetDate': '2025-12-09', 'releaseDate': '2025-11-18'}], 'estimatedResultsFirstSubmitDate': '2022-11-29'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-21', 'size': 270106, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-10-06T10:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4304}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-10', 'studyFirstSubmitDate': '2022-10-06', 'studyFirstSubmitQcDate': '2022-10-06', 'lastUpdatePostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'COVID-19 Booster Dose', 'timeFrame': '90 days', 'description': 'Number of patients that received a COVID-19 booster dose during follow-up based on electronic health data. Receipt of a COVID-19 booster dose within 90 days of randomization (yes/no) will be assessed using vaccination data available from the Marshfield Clinic Health System (MCHS) electronic health record, which includes vaccinations administered outside of MCHS through data exchanges with the Wisconsin Immunization Registry. Specifically patients will be classified as having received a COVID-19 booster dose if they have record of receipt of COVID-19 booster dose with a vaccination date during the 90-day follow-up period.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['reminder/recall', 'COVID-19', 'intervention', 'adolescents'], 'conditions': ['COVID-19 Vaccines']}, 'descriptionModule': {'briefSummary': 'A single COVID-19 booster dose has been recommended in the United States for adolescents aged ≥12 years to enhance protection against SARS-CoV-2 infection. This study will assess the efficacy of a one-time reminder/recall for COVID-19 booster dose among eligible adolescents in a regional healthcare system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Marshfield Clinic Health System patient aged 12-17 years with at least one preventive visit or two evaluation \\& management visits with a Marshfield Clinic Health System provider in the last 36 months\n* Due for a COVID-19 booster dose (completed the COVID-19 primary series and it has been ≥5 months since their second dose)\n\nExclusion Criteria:\n\n* Primary care provider is not affiliated with Marshfield Clinic Health System\n* Opted out of Marshfield Clinic Health System centralized vaccine reminder notifications\n* Received COVID-19 vaccine off label\n* Missing or invalid contact information\n* Deceased'}, 'identificationModule': {'nctId': 'NCT05571657', 'acronym': 'AIMED COVID', 'briefTitle': 'COVID-19 Booster Dose Reminder/Recall for Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Marshfield Clinic Research Foundation'}, 'officialTitle': 'Understanding and Addressing the Disparity in Vaccination Coverage Among U.S. Adolescents Living in Rural Versus Urban Areas', 'orgStudyIdInfo': {'id': 'MCL10517a'}, 'secondaryIdInfos': [{'id': 'U01IP001093', 'link': 'https://reporter.nih.gov/quickSearch/U01IP001093', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Reminder/recall', 'interventionNames': ['Behavioral: Reminder/Recall Sent Via Preferred Method of Communication']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'No Reminder/Recall'}], 'interventions': [{'name': 'Reminder/Recall Sent Via Preferred Method of Communication', 'type': 'BEHAVIORAL', 'description': "Parents of 12-17 year-old patients due for COVID-19 booster dose will receive a one-time vaccine reminder/recall via the parent's preferred method of communication (mailed letter, text message, email)", 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54449', 'city': 'Marshfield', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Marshfield Clinic Health System', 'geoPoint': {'lat': 44.66885, 'lon': -90.1718}}], 'overallOfficials': [{'name': 'Huong McLean, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Marshfield Clinic Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marshfield Clinic Research Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Scientist', 'investigatorFullName': 'Huong McLean, PhD', 'investigatorAffiliation': 'Marshfield Clinic Research Foundation'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-11-29', 'type': 'RELEASE'}, {'date': '2023-09-27', 'type': 'RESET'}, {'date': '2025-11-18', 'type': 'RELEASE'}, {'date': '2025-12-09', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Huong Nguyen, PhD, Senior Research Scientist, Marshfield Clinic Research Foundation'}}}}