Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-30 @ 6:34 PM
Study NCT ID:
NCT05722132
Status:
COMPLETED
Last Update Posted:
2023-04-06
First Post:
2022-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Latinos Kick Buts: Mobile Engagement and Cessation Support for Latinos Who Smoke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2826}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-03-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-04', 'studyFirstSubmitDate': '2022-12-16', 'studyFirstSubmitQcDate': '2023-02-07', 'lastUpdatePostDateStruct': {'date': '2023-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participant who enroll in cessation program', 'timeFrame': '16 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Smoking Cessation']}, 'descriptionModule': {'briefSummary': 'Latino Kick Buts (LKB) is a smoking cessation treatment program available to Strong Memorial Hospital patients who smoke. LKB encompasses two integrated components: (1) a 12-week text messaging counseling program with interactive capabilities and (2) pharmacotherapy support (provision of nicotine replacement therapy at no cost). LKB utilization among Latinos who smoke remains minimal. This study aims to identify the types of text messages more effective in enrolling Latinos who smoke, identified in the electronic medical record, into LKB.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult Latinos who smoke and have received medical care at Strong Memorial Hospital/SHARP healthcare within the last year.\n* having smoking status recorded in the EMR\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT05722132', 'briefTitle': 'Latinos Kick Buts: Mobile Engagement and Cessation Support for Latinos Who Smoke', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Latinos Kick Buts: Mobile Engagement and Cessation Support for Latinos Who Smoke', 'orgStudyIdInfo': {'id': 'STUDY00007635'}, 'secondaryIdInfos': [{'id': 'R42MD010318', 'link': 'https://reporter.nih.gov/quickSearch/R42MD010318', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'One cycle-no monetary incentive', 'interventionNames': ['Behavioral: One cycle']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'One cycle-fixed amount of incentive', 'interventionNames': ['Behavioral: One cycle', 'Behavioral: 5 Dollar Incentive']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'One cycle-raffle as incentive', 'interventionNames': ['Behavioral: One cycle', 'Behavioral: Raffle Incentive']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4 cycles- no monetary incentive', 'interventionNames': ['Behavioral: 4 cycles']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4 cycles- fixed amount of incentive', 'interventionNames': ['Behavioral: 4 cycles', 'Behavioral: 5 Dollar Incentive']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4 cycles- raffle as incentive', 'interventionNames': ['Behavioral: 4 cycles', 'Behavioral: Raffle Incentive']}], 'interventions': [{'name': 'One cycle', 'type': 'BEHAVIORAL', 'description': 'Message Design Participants will receive 3 messages per cycle that contain information on how to enroll in a cessation program.', 'armGroupLabels': ['One cycle-fixed amount of incentive', 'One cycle-no monetary incentive', 'One cycle-raffle as incentive']}, {'name': '4 cycles', 'type': 'BEHAVIORAL', 'description': 'Participants will receive 3 messages per cycle that contain information on how to enroll in a cessation program.', 'armGroupLabels': ['4 cycles- fixed amount of incentive', '4 cycles- no monetary incentive', '4 cycles- raffle as incentive']}, {'name': '5 Dollar Incentive', 'type': 'BEHAVIORAL', 'description': 'Participants will receive 3 messages per cycle that contain information on how to enroll in a cessation program. The introductory message will mention that participants will receive $5 if they enroll in the program or that they should look out for messages with a "$" sign at the beginning that will provide an incentive if they respond.', 'armGroupLabels': ['4 cycles- fixed amount of incentive', 'One cycle-fixed amount of incentive']}, {'name': 'Raffle Incentive', 'type': 'BEHAVIORAL', 'description': 'The incentive message (indicated with a leading "$" sign) will invite participants to respond, and participants that do so will be included in a random drawing depending on the condition. The incentive message for the opportunity to win will contain a link to a website that provides full details of the timing of the drawing, the chances of winning, and when notification of winners will be made.', 'armGroupLabels': ['4 cycles- raffle as incentive', 'One cycle-raffle as incentive']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Paula Cupertino', 'investigatorAffiliation': 'University of Rochester'}}}}