Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 6:27 PM
Study NCT ID:
NCT05612360
Status:
COMPLETED
Last Update Posted:
2023-03-03
First Post:
2022-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Message Encouraging Vaccination in Preparation for the Holidays
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "As treated participants will receive text messages, there is no scope for blinding. Care providers will not be made aware of subjects' participation in the study, or assigned treatment arms. The study team will only receive data on subjects' assigned arms and outcomes at the end of the study."}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned to the different arms.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 520000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-01', 'studyFirstSubmitDate': '2022-11-03', 'studyFirstSubmitQcDate': '2022-11-03', 'lastUpdatePostDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'COVID bivalent booster receipt', 'timeFrame': 'During the 30 days after receiving the SMS/MMS intervention', 'description': 'Whether patients receive a bivalent COVID booster at the pharmacy in question'}], 'secondaryOutcomes': [{'measure': 'COVID bivalent booster receipt', 'timeFrame': '60 days after receiving the SMS/MMS intervention', 'description': 'Whether patients receive a bivalent COVID booster at the pharmacy in question'}, {'measure': 'COVID bivalent booster receipt', 'timeFrame': '90 days after receiving the SMS/MMS intervention', 'description': 'Whether patients receive a bivalent COVID booster at the pharmacy in question'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'behavioral science interventions', 'vaccination promotion'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'This experiment is part of a megastudy with a total of ten experimental conditions and a holdout control condition to which patients will be randomly assigned. Ther focal comparison in this experiment is between a message encouraging vaccination by reminding participants that the holiday season is just a few weeks away and getting vaccinated will allow them to more safely gather with loved ones and a control message telling patients that an updated COVID booster vaccine is waiting for them. The intervention testing if text messages encouraging vaccination by reminding participants that the holiday season is just a few weeks away and getting vaccinated will allow them to more safely gather with loved ones will produce more vaccinations than otherwise identical messages.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Exclusion Criteria:\n\n1. The patient unsubscribed from texts before the send date and time of the patient's SMS/MMS message\n2. The patient received a bivalent COVID booster before the send date and time of the patient's SMS/MMS message."}, 'identificationModule': {'nctId': 'NCT05612360', 'briefTitle': 'Message Encouraging Vaccination in Preparation for the Holidays', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Message Encouraging Vaccination in Preparation for the Holidays', 'orgStudyIdInfo': {'id': '851911-Trial B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control condition with "waiting for you" message', 'description': 'This control condition will use the text message that the investigators found to be the best performing in their last mega-study of vaccine text messages to recommend a COVID vaccination.', 'interventionNames': ['Behavioral: COVID Booster text messages']}, {'type': 'EXPERIMENTAL', 'label': 'Message encouraging vaccination in preparation for the holidays', 'description': 'This condition will use a text message to encourage a COVID vaccination in preparation for the holidays.', 'interventionNames': ['Behavioral: COVID Booster text messages']}], 'interventions': [{'name': 'COVID Booster text messages', 'type': 'BEHAVIORAL', 'description': 'Participants will receive text messages per descriptions listed in the arms.', 'armGroupLabels': ['Control condition with "waiting for you" message', 'Message encouraging vaccination in preparation for the holidays']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}