Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-24 @ 5:55 PM
Study NCT ID:
NCT06666868
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-31
First Post:
2024-10-29
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CARD for Community Pharmacy Vaccinations - Phase 2
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', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Vaccine clients are blinded to the hypothesis. Providers are aware of the intervention.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Cluster trial involving at least 8 community pharmacies allocated in a 1:1 ratio to: 1) repeat use or 2) first-time use of the CARD system for vaccination delivery in 2024-2025 fall/winter vaccination season.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-29', 'studyFirstSubmitDate': '2024-10-29', 'studyFirstSubmitQcDate': '2024-10-29', 'lastUpdatePostDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Experience with vaccination', 'timeFrame': 'Within 15 minutes of vaccination', 'description': 'Self-reported experience about how much CARD helped (4-point Likert scale and dichotomized)'}], 'secondaryOutcomes': [{'measure': 'Pain', 'timeFrame': 'Within 15 minutes of vaccination', 'description': 'Self-reported pain during vaccination (0-10)'}, {'measure': 'Fear', 'timeFrame': 'Within 15 minutes of vaccination', 'description': 'Self-reported fear during vaccination (0-10)'}, {'measure': 'Dizziness', 'timeFrame': 'Within 15 minutes of vaccination', 'description': 'Self-reported dizziness during vaccination (0-10)'}, {'measure': 'Fainting', 'timeFrame': 'Within 15 minutes of vaccination', 'description': 'Self-reported fainting during vaccination (yes/no) confirmed by provider'}, {'measure': 'Overall experience', 'timeFrame': 'Within 15 minutes of vaccination', 'description': 'Self-reported overall experience (5-point Likert scale, and dichotomized)'}, {'measure': 'Vaccination decision-making', 'timeFrame': 'Within 15 minutes of vaccination', 'description': 'Self-reported vaccination decision-making (5-point Likert scale, and dichotomized)'}, {'measure': 'Implementation outcomes', 'timeFrame': 'Within 3 months of vaccination season ending', 'description': 'Provider quantitative and qualitative feedback on surveys and interviews (assessing implementation outcomes)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vaccination reaction', 'vaccination experience'], 'conditions': ['Vaccination', 'Vaccination Pain', 'Vaccination Reaction', 'Vaccination Pharmacy']}, 'descriptionModule': {'briefSummary': 'This study is phase 2 of a cluster trial integrating the CARD (Comfort Ask Relax System) in community pharmacies affiliated with Wholehealth Pharmacy Partners. It involves continuing CARD in pharmacies randomized to CARD in phase 1 of the trial (2023-2024 fall/winter vaccination season), and initiating CARD in pharmacies randomized to Control (usual care) in phase 1 of the trial. Both groups will use CARD for delivery of vaccinations during the 2024-2025 fall/winter vaccination season.', 'detailedDescription': 'This study is a continuation of a previous cluster trial. Pharmacies that participated in the original trial will be asked if they want to volunteer for the present study. They will all use the CARD system as the vaccination delivery system for their community pharmacies during the 2024-2025 fall/winter vaccination season. They will collect feedback from vaccine clients using a paper survey that tracks experiences, including symptoms, during vaccination. The responses will be compared between groups.\n\nThe sample size is limited by the number of pharmacies that volunteer. We expect 8 pharmacies will participate in a 1:1 ratio (about 1/3 of all pharmacies in original cluster trial), with a total of at least 500 vaccination clients. We will collect data for all vaccinations that are conducted and for which client feedback data are available. Thus, the sample size is expected to deviate from the estimated sample size of 500.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clients undergoing vaccination in participating pharmacies and providers working in participating pharmacies\n\nExclusion Criteria:\n\n* able to speak and write in English'}, 'identificationModule': {'nctId': 'NCT06666868', 'briefTitle': 'CARD for Community Pharmacy Vaccinations - Phase 2', 'organization': {'class': 'OTHER', 'fullName': 'University of Toronto'}, 'officialTitle': 'CARD (Comfort Ask Relax Distract) for Community-based Pharmacy Vaccinations - Phase 2', 'orgStudyIdInfo': {'id': '43097-2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sustained CARD', 'description': 'CARD is being used for the 2nd year in a row as the vaccination delivery framework in participating pharmacies (It was used in the 2023-2024 fall/winter vaccination season and is now being sustained in the 2024-2025 fall/winter season). CARD comprises of education, environment, engagement and evaluation components.', 'interventionNames': ['Behavioral: Sustained CARD']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'First-time CARD', 'description': 'CARD is being used for the 1st time as the vaccination delivery framework in participating pharmacies (2024-2025 fall/winter vaccinations only). CARD comprises of education, environment, engagement and evaluation components.', 'interventionNames': ['Behavioral: First-time CARD']}], 'interventions': [{'name': 'Sustained CARD', 'type': 'BEHAVIORAL', 'otherNames': ['Sustained CARD use'], 'description': 'This group is using CARD for the 2nd year in a row in participating pharmacies as the vaccination delivery framework (It was used in the 2023-2024 fall/winter vaccination season and is now being sustained in the 2024-2025 fall/winter vaccination season).', 'armGroupLabels': ['Sustained CARD']}, {'name': 'First-time CARD', 'type': 'BEHAVIORAL', 'otherNames': ['First-time CARD use'], 'description': 'CARD is being used for the 1st time in participating pharmacies as the vaccination delivery framework (2024-2025 fall/winter vaccination season).', 'armGroupLabels': ['First-time CARD']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5S 3M2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Anna Taddio, PhD', 'role': 'CONTACT', 'email': 'anna.taddio@utoronto.ca', 'phone': '416-978-2889'}, {'name': 'Anna Taddio, PhD', 'role': 'CONTACT'}], 'facility': 'Leslie Dan Faculty of Pharmacy, University of Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Charlotte Logeman, MPH', 'role': 'CONTACT', 'email': 'charlotte.logeman@utoronto.ca', 'phone': '416-978-2889'}, {'name': 'Victoria Gudzak, MSc', 'role': 'CONTACT', 'email': 'victoria.gudzak@mail.utoronto.ca', 'phone': '416-978-2889'}], 'overallOfficials': [{'name': 'Anna Taddio, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Leslie Dan Faculty Of Pharmacy, University Of Toronto'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We do not have permission to share individual participant data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wholehealth Pharmacy Partners', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Anna Taddio', 'investigatorAffiliation': 'University of Toronto'}}}}