Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2026-01-02 @ 6:21 AM
Study NCT ID:
NCT03332992
Status:
COMPLETED
Last Update Posted:
2018-05-15
First Post:
2017-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Tests of Flu Vaccination Phone Messages
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020408', 'term': 'Health Insurance Portability and Accountability Act'}], 'ancestors': [{'id': 'D007348', 'term': 'Insurance, Health'}, {'id': 'D007341', 'term': 'Insurance'}, {'id': 'D005381', 'term': 'Financing, Organized'}, {'id': 'D004467', 'term': 'Economics'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D007878', 'term': 'Legislation as Topic'}, {'id': 'D012926', 'term': 'Social Control, Formal'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-30', 'size': 275985, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2017-10-30T14:17', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7206}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-13', 'studyFirstSubmitDate': '2017-10-30', 'studyFirstSubmitQcDate': '2017-11-01', 'lastUpdatePostDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vaccination intentions (Time 1)', 'timeFrame': 'Day 1 (Assessed during the intervention telephone call)', 'description': 'Question (language being manipulated) asking whether respondent intends to vaccinate'}], 'secondaryOutcomes': [{'measure': 'Documented influenza vaccination', 'timeFrame': 'Within 6 months / during 2017-2018 influenza season', 'description': "Documentation (when available from Emmi Solutions' clients) via clients' employee records that influenza vaccination occurred"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Influenza, Human']}, 'descriptionModule': {'briefSummary': "This project is a partnership between Emmi Solutions, a private company that delivers health promotion messages to employees of client organizations, and the University of Michigan and affiliated academic investigators. In particular, Emmi sends out pre-recorded and interactive telephone calls on behalf of their healthcare clients to promote influenza vaccination each Fall. The collaboration will design various scripts (based on established risk communication, behavior change, and behavioral economic principles) to be pre-recorded and sent out on these calls on a randomized basis (with approval by client organizations), with the number of arms to vary based on the size of each client's participant list (to ensure sufficient statistical power within each client's sample). Emmi will deliver the calls and track individual responses to questions posed during the call. Emmi will then provide a de-identified dataset to the academic research team for analysis to determine whether any scripts provided greater or lesser effects to people's their motivations to get a flu vaccination."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient of client organizations of Emmi Solutions\n* Provided a phone number to their care team\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03332992', 'briefTitle': 'Comparative Tests of Flu Vaccination Phone Messages', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Comparative Tests of Flu Vaccination Phone Messages', 'orgStudyIdInfo': {'id': 'HUM00135995'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Viral changes + General intentions', 'description': "Script language discusses a) that previous years' shots do not protect against current year influenza (viral changes) and b) poses a general question asking whether the respondent intends to get a flu shot (general intentions).", 'interventionNames': ['Behavioral: Viral changes', 'Behavioral: General intentions']}, {'type': 'EXPERIMENTAL', 'label': 'Viral changes + Behavioral intentions', 'description': "Script language discusses a) that previous years' shots do not protect against current year influenza (viral changes) and b) poses a question asking when / where the respondent will get a flu shot (behavioral intention).", 'interventionNames': ['Behavioral: Viral changes', 'Behavioral: Behavioral intentions']}, {'type': 'EXPERIMENTAL', 'label': 'Viral changes + Accountability', 'description': "Script language discusses a) that previous years' shots do not protect against current year influenza (viral changes) and b) poses a question that implies the patient's care team will be notified of intent to vaccinate (accountability to providers).", 'interventionNames': ['Behavioral: Viral changes', 'Behavioral: Accountability']}, {'type': 'EXPERIMENTAL', 'label': 'Protect others + General intentions', 'description': 'Script language discusses a) that getting the flu shot protects others who can get particularly sick (protect others) and b) poses a general question asking whether the respondent intends to get a flu shot (general intentions).', 'interventionNames': ['Behavioral: Protect others', 'Behavioral: General intentions']}, {'type': 'EXPERIMENTAL', 'label': 'Protect others + Behavioral intentions', 'description': 'Script language discusses a) that getting the flu shot protects others who can get particularly sick (protect others) and b) poses a question asking when / where the respondent will get a flu shot (behavioral intention).', 'interventionNames': ['Behavioral: Protect others', 'Behavioral: Behavioral intentions']}, {'type': 'EXPERIMENTAL', 'label': 'Protect others + Accountability', 'description': "Script language discusses a) that getting the flu shot protects others who can get particularly sick (protect others) and b) poses a question that implies the patient's care team will be notified of intent to vaccinate (accountability to providers).", 'interventionNames': ['Behavioral: Protect others', 'Behavioral: Accountability']}], 'interventions': [{'name': 'Viral changes', 'type': 'BEHAVIORAL', 'description': 'Telephone script language provided pre-questions regarding the fact that influenza viruses change each year', 'armGroupLabels': ['Viral changes + Accountability', 'Viral changes + Behavioral intentions', 'Viral changes + General intentions']}, {'name': 'Protect others', 'type': 'BEHAVIORAL', 'description': 'Telephone script language provided pre-questions emphasizing the need to protect vulnerable others', 'armGroupLabels': ['Protect others + Accountability', 'Protect others + Behavioral intentions', 'Protect others + General intentions']}, {'name': 'General intentions', 'type': 'BEHAVIORAL', 'description': 'Question language asking about general interest in getting influenza vaccination', 'armGroupLabels': ['Protect others + General intentions', 'Viral changes + General intentions']}, {'name': 'Behavioral intentions', 'type': 'BEHAVIORAL', 'description': 'Question language asking individual to make specific plans to be vaccinated', 'armGroupLabels': ['Protect others + Behavioral intentions', 'Viral changes + Behavioral intentions']}, {'name': 'Accountability', 'type': 'BEHAVIORAL', 'description': 'Question language asking individual whether their care team can learn about their vaccination intentions', 'armGroupLabels': ['Protect others + Accountability', 'Viral changes + Accountability']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60606', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Emmi Solutions', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Brian J Zikmund-Fisher, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Emmi Solutions', 'class': 'UNKNOWN'}, {'name': 'University of Iowa', 'class': 'OTHER'}, {'name': 'University of Utah', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Brian Zikmund-Fisher', 'investigatorAffiliation': 'University of Michigan'}}}}