Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-27 @ 7:37 PM
Study NCT ID:
NCT05977192
Status:
COMPLETED
Last Update Posted:
2025-03-21
First Post:
2023-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mobile Health-based Motivational Interviewing to Promote COVID-19 Vaccination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000088823', 'term': 'Vaccination Hesitancy'}], 'ancestors': [{'id': 'D000072758', 'term': 'Vaccination Refusal'}, {'id': 'D016312', 'term': 'Treatment Refusal'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072860', 'term': 'Ecological Momentary Assessment'}], 'ancestors': [{'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-17', 'studyFirstSubmitDate': '2023-07-30', 'studyFirstSubmitQcDate': '2023-08-02', 'lastUpdatePostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of total of ecological momentary assessment messages opened/viewed', 'timeFrame': '8 weeks (from baseline to follow up)'}], 'primaryOutcomes': [{'measure': 'Changes in vaccine hesitancy and confidence', 'timeFrame': 'Baseline and follow-up (8 weeks)'}, {'measure': 'Changes in intention to receive the vaccine', 'timeFrame': 'Baseline and follow-up (8 weeks)'}], 'secondaryOutcomes': [{'measure': 'Changes in expectations related to vaccines', 'timeFrame': 'Baseline and follow-up (8 weeks)'}, {'measure': 'Changes in self-efficacy', 'timeFrame': 'Baseline and follow-up (8 weeks)'}, {'measure': 'Changes in ambivalence', 'timeFrame': 'Baseline and follow-up (8 weeks)'}, {'measure': 'Changes in value-behavior discrepancy', 'timeFrame': 'Baseline and follow-up (8 weeks)'}, {'measure': 'Number of participants who receive the COVID-19 vaccine', 'timeFrame': 'Follow-up (8 weeks)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vaccination Hesitancy']}, 'referencesModule': {'references': [{'pmid': '40294409', 'type': 'DERIVED', 'citation': 'Braun A, Corcoran S, Tu Doan K, Jernigan C, Moriasi C, Businelle M, Bui T. Mobile Health-Based Motivational Interviewing to Promote SARS-CoV-2 Vaccination in Rural Adults: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2025 Apr 28;14:e64010. doi: 10.2196/64010.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the preliminary efficacy and acceptability of an mobile Health-based motivational interviewing (MI) intervention to promote SARS-CoV-2 vaccination (MOTIVACC) compared to traditional phone-based MI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 years\n* Reside in a rural area\n* No previous dose of a SARS-CoV-2 vaccine\n* Speak English\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* A cognitive or other disability that inhibits smart phone use\n* Inability to participate because of medical or psychiatric conditions diagnosed by a physician/clinician\n* Enrollment in other COVID-19 research; pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT05977192', 'acronym': 'COVID-19', 'briefTitle': 'Mobile Health-based Motivational Interviewing to Promote COVID-19 Vaccination', 'organization': {'class': 'OTHER', 'fullName': 'Oklahoma State University'}, 'officialTitle': 'Mobile Health-based Motivational Interviewing to Promote Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Vaccination in Oklahomans', 'orgStudyIdInfo': {'id': 'IRB-22-282-STW'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard MI', 'interventionNames': ['Behavioral: Standard MI', 'Behavioral: Ecological momentary assessment (EMA) messages']}, {'type': 'EXPERIMENTAL', 'label': 'Intensive MI', 'interventionNames': ['Behavioral: Intensive MI', 'Behavioral: Ecological momentary assessment (EMA) messages']}, {'type': 'EXPERIMENTAL', 'label': 'MOTIVACC', 'interventionNames': ['Behavioral: MOTIVACC', 'Behavioral: Ecological momentary assessment (EMA) messages']}], 'interventions': [{'name': 'Standard MI', 'type': 'BEHAVIORAL', 'description': 'One phone-based MI session', 'armGroupLabels': ['Standard MI']}, {'name': 'Intensive MI', 'type': 'BEHAVIORAL', 'description': 'Four phone-based MI sessions', 'armGroupLabels': ['Intensive MI']}, {'name': 'MOTIVACC', 'type': 'BEHAVIORAL', 'description': 'mHealth-based MI', 'armGroupLabels': ['MOTIVACC']}, {'name': 'Ecological momentary assessment (EMA) messages', 'type': 'BEHAVIORAL', 'description': 'EMA messages focused on vaccinations and health', 'armGroupLabels': ['Intensive MI', 'MOTIVACC', 'Standard MI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '74078', 'city': 'Stillwater', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma State University', 'geoPoint': {'lat': 36.11561, 'lon': -97.05837}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oklahoma State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Oklahoma', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ashlea Braun', 'investigatorAffiliation': 'Oklahoma State University Center for Health Sciences'}}}}