Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2026-01-03 @ 11:11 PM
Study NCT ID:
NCT07236034
Status:
RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ARISe at UMass Chan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Participants will be assigned to one of 14 conditions and view two messages within each.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2025-10-01', 'studyFirstSubmitQcDate': '2025-11-17', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Source credibility', 'timeFrame': 'Immediately after viewing each message', 'description': "Participants' perception of the credibility of the message source will be assessed using a 7-point Likert scale measured across four items. Participants will be asked to rate the following four items on this scale: To what extent do you believe the source of the message to be… (1=not at all, 7=very much so)\n\n1. Fair\n2. Accurate\n3. Telling the whole story\n4. Trustworthy\n\nUnit of measure: Scale score 1-7, mean"}, {'measure': 'Perceived Message Effectiveness', 'timeFrame': 'Immediately after viewing each message', 'description': 'Perceived message effectiveness will be measured using six items (worth remembering, grabs attention, powerful, informative, meaningful, convincing), each rated on a 7-point Likert scale. The outcome will be the mean of these six ratings for each participant, then averaged by experimental condition.\n\nTo what extent is… (1=not at all, 7=very much so)\n\n1. The message worth remembering\n2. The message grabs attention\n3. This message powerful\n4. This message informative\n5. This message meaningful\n6. This message convincing Unit of Measure: Scale score (1-7, mean across items)'}, {'measure': 'Visual attention', 'timeFrame': 'During message viewing ( immediately post-randomization, prior to completion of post-message survey)', 'description': 'Visual attention, quantified as mean dwell time in milliseconds, will be measured using remote eye-tracking while participants view vaccine promotion messages. Dwell time will be calculated for pre-specified Areas of Interest (AOIs) during the message viewing period. Higher dwell times indicate greater visual attention to the AOIs.\n\nUnit of measure: mean dwell time in milliseconds per message'}, {'measure': 'Message reactance', 'timeFrame': 'Immediately after viewing each message', 'description': 'Reactance will be assessed using four items (irritated, angry, annoyed, aggravated), rated 0 ("None of this feeling") to 4 ("A great deal of this feeling"). The mean reactance score will be calculated for each participant.\n\nHow much did this message make you feel the following way? Response options: 0 (None of this feeling) to 4 (A great deal of this feeling).\n\n1. Irritated\n2. Angry\n3. Annoyed\n4. Aggravated\n\nUnit of Measure: Scale score (0-4, mean across items)'}, {'measure': 'Information sharing intentions', 'timeFrame': 'Immediately after viewing each message', 'description': 'Description: Assessed with 6 items regarding interpersonal and online sharing, rated 1 (Strongly disagree) to 5 (Strongly agree). The mean score across items will be reported per participant and per condition.\n\nRate with the following statements on a scale from 1 (Strongly disagree) to 5 (Strongly agree).\n\nInterpersonal setting\n\n1. I would be willing to share this information with others.\n2. I would talk with others about this message.\n3. I would point others in a direction where they could read this message.\n\n Online setting\n4. I would be willing to post a link to this information on my social media.\n5. I would like a social media post with this information.\n6. I would share a social media post with this information.\n\nUnit of Measure: Scale score (1-5, mean across items)'}], 'secondaryOutcomes': [{'measure': 'Vaccine perceptions', 'timeFrame': 'Assessed at baseline (prior to message exposure) and immediately post-intervention (after message exposure)', 'description': 'Vaccine perceptions will be measured using an 8-item scale, administered pre- and post-message exposure. Items are rated from 1 (Strongly disagree/very negative) to 7 (Strongly agree/very positive). Higher scores indicate more positive vaccine perceptions. The outcome will be the mean change in score from pre- to post-exposure.\n\nUnit of Measure: Scale score (1-7, mean change)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Message perceptions', 'Vaccination', 'Immunization'], 'conditions': ['Vaccination', 'Vaccination Promotion']}, 'descriptionModule': {'briefSummary': 'The goal is to identify the most impactful strategies for capturing attention and enhancing effectiveness of vaccine promotion messages. This will be done using an online survey that employs remote eye-tracking and self report measures to evaluate response to sample vaccine promotion social media content in rural populations in New England. Participants will be randomly assigned into one of 14 conditions in a 2(source: expert vs. influencer) by 7 (themes: constructs from 7C Vaccine Framework) experiment and view sample messages and then answer questions about their attitudes and beliefs while being monitored for eye-tracking.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18+\n* Living in New England state (CT, MA, ME, NH, VT RI) in a zip code as defined by each individual state's definition of rural\n* Able to read and write in English\n* Access to an internet connected computer or laptop with a web-camera\n\nExclusion Criteria:\n\n* N/A"}, 'identificationModule': {'nctId': 'NCT07236034', 'acronym': 'ARISe', 'briefTitle': 'ARISe at UMass Chan', 'organization': {'class': 'OTHER', 'fullName': 'University of Massachusetts, Worcester'}, 'officialTitle': 'ARISe at UMass Chan: Remote Eye Tracking Study of Vaccine Messaging in Rural Populations', 'orgStudyIdInfo': {'id': 'STUDY00002075'}, 'secondaryIdInfos': [{'id': '1U48DP006883-01', 'link': 'https://reporter.nih.gov/quickSearch/1U48DP006883-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: Peer message, 7C Construct 1', 'description': 'This arm will include messages with a "peer" influence as the source and the construct of "confidence" as the message.', 'interventionNames': ['Behavioral: Exposure to source and message content']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: Professional source, 7C Construct 1', 'description': 'This arm will include messages with a "professional" influencer as the source and the construct of "confidence" as the message.', 'interventionNames': ['Behavioral: Exposure to source and message content']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3: Peer message, 7C Construct 2', 'description': 'This arm will include messages with a "peer" influence as the source and the construct of "complacency" as the message.', 'interventionNames': ['Behavioral: Exposure to source and message content']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 4: Professional message, 7C Construct 2', 'description': 'This arm will include messages with a "professional" influence as the source and the construct of "complacency" as the message.', 'interventionNames': ['Behavioral: Exposure to source and message content']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 5: Peer message, 7C Construct 3', 'description': 'This arm will include messages with a "peer" influence as the source and the construct of "constraints" as the message.', 'interventionNames': ['Behavioral: Exposure to source and message content']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 6: Professional message, 7C Construct 3', 'description': 'This arm will include messages with a "professional" influencer as the source and the construct of "constraints" as the message.', 'interventionNames': ['Behavioral: Exposure to source and message content']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 7: Peer message, 7C Construct 4', 'description': 'This arm will include messages with a "peer" influencer as the source and the construct of "calculation" as the message.', 'interventionNames': ['Behavioral: Exposure to source and message content']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 8: Professional message, 7C Construct 4', 'description': 'This arm will include messages with a "professional" influencer as the source and the construct of "calculation" as the message.', 'interventionNames': ['Behavioral: Exposure to source and message content']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 9: Peer message, 7C Construct 5', 'description': 'This arm will include messages with a "peer" influencer as the source and the construct of "collective responsibility" as the message.', 'interventionNames': ['Behavioral: Exposure to source and message content']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 10: Professional message, 7C Construct 5', 'description': 'This arm will include messages with a "professional" influencer as the source and the construct of "collective responsibility" as the message.', 'interventionNames': ['Behavioral: Exposure to source and message content']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 11: Peer message; 7C Construct 6', 'description': 'This arm will include messages with a "peer" influencer as the source and the construct of "compliance" as the message.', 'interventionNames': ['Behavioral: Exposure to source and message content']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 12: Professional message, 7C Construct 6', 'description': 'This arm will include messages with a "professional" influencer as the source and the construct of "compliance" as the message.', 'interventionNames': ['Behavioral: Exposure to source and message content']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 13: Peer message, 7C Construct 7', 'description': 'This arm will include messages with a "peer" influencer as the source and the construct of "conspiracy" as the message.', 'interventionNames': ['Behavioral: Exposure to source and message content']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 14: Professional message, 7C Construct 7', 'description': 'This arm will include messages with a "professional" influencer as the source and the construct of "conspiracy" as the message.', 'interventionNames': ['Behavioral: Exposure to source and message content']}], 'interventions': [{'name': 'Exposure to source and message content', 'type': 'BEHAVIORAL', 'description': 'Within each arm, participants will be exposed to two messages each of which are delivered by the same source (peer or professional) and have message content related to one of the 7C Constructs.', 'armGroupLabels': ['Arm 10: Professional message, 7C Construct 5', 'Arm 11: Peer message; 7C Construct 6', 'Arm 12: Professional message, 7C Construct 6', 'Arm 13: Peer message, 7C Construct 7', 'Arm 14: Professional message, 7C Construct 7', 'Arm 1: Peer message, 7C Construct 1', 'Arm 2: Professional source, 7C Construct 1', 'Arm 3: Peer message, 7C Construct 2', 'Arm 4: Professional message, 7C Construct 2', 'Arm 5: Peer message, 7C Construct 3', 'Arm 6: Professional message, 7C Construct 3', 'Arm 7: Peer message, 7C Construct 4', 'Arm 8: Professional message, 7C Construct 4', 'Arm 9: Peer message, 7C Construct 5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01605', 'city': 'Worcester', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Grace Assistant Professor, PhD, MPH', 'role': 'CONTACT', 'email': 'arise@umassmed.edu', 'phone': '508-859-0179'}], 'facility': 'University of Massachusetts Chan Medical School', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}], 'centralContacts': [{'name': 'Grace W Ryan, PhD, MPH', 'role': 'CONTACT', 'email': 'grace.ryan1@umassmed.edu', 'phone': '508-859-0179'}], 'overallOfficials': [{'name': 'Grace W Ryan, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Massachusetts Chan Medical School'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Per the data management plan, datasets and codebooks will be provided to individual researchers upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Massachusetts, Worcester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Grace Ryan', 'investigatorAffiliation': 'University of Massachusetts, Worcester'}}}}