- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05722132
Latinos Kick Buts: Mobile Engagement and Cessation Support for Latinos Who Smoke
April 4, 2023 updated by: Paula Cupertino, University of Rochester
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2826
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Francisco Cartujano, MD
- Phone Number: 585-504-9461
- Email: francisco_cartujano@urmc.rochester.edu
Study Locations
-
-
New York
-
Rochester, New York, United States, 14642
- University of Rochester Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult Latinos who smoke and have received medical care at Strong Memorial Hospital/SHARP healthcare within the last year.
- having smoking status recorded in the EMR
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: One cycle-no monetary incentive
|
Message Design Participants will receive 3 messages per cycle that contain information on how to enroll in a cessation program.
|
Active Comparator: One cycle-fixed amount of incentive
|
Message Design Participants will receive 3 messages per cycle that contain information on how to enroll in a cessation program.
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.
|
Active Comparator: One cycle-raffle as incentive
|
Message Design Participants will receive 3 messages per cycle that contain information on how to enroll in a cessation program.
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.
|
Active Comparator: 4 cycles- no monetary incentive
|
Participants will receive 3 messages per cycle that contain information on how to enroll in a cessation program.
|
Active Comparator: 4 cycles- fixed amount of incentive
|
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.
Participants will receive 3 messages per cycle that contain information on how to enroll in a cessation program.
|
Active Comparator: 4 cycles- raffle as incentive
|
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.
Participants will receive 3 messages per cycle that contain information on how to enroll in a cessation program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of participant who enroll in cessation program
Time Frame: 16 weeks
|
16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 27, 2022
Primary Completion (Actual)
March 25, 2023
Study Completion (Actual)
March 25, 2023
Study Registration Dates
First Submitted
December 16, 2022
First Submitted That Met QC Criteria
February 7, 2023
First Posted (Actual)
February 10, 2023
Study Record Updates
Last Update Posted (Actual)
April 6, 2023
Last Update Submitted That Met QC Criteria
April 4, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00007635
- R42MD010318 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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