- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03927976
Feasibility of a Culturally-Specific Video Text Cessation Intervention With AA Quitline Callers
Testing the Feasibility of a Culturally-Specific Video Text Cessation Intervention With African American Quitline Callers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44106
- Case Western Reserve University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Self-identify as African American
- Enrolled in state quitlines within the past 3 months
- Have access to SMS texting
Exclusion Criteria:
- Does not meet inclusion criteria
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Path2Quit
After assessment eligibility, given consent, information about text messaging will be collected and participants enrolled in the Path2Quit culturally specific text message program and feedback will be collected on their experience.
|
SMS text delivers over 6 weeks with links to 20-120 second video clips from PTF.
The message library contains 155 videos and assessment questions.
First message is tailored to wake-up times, and the topic of the video (e.g., Never Quit Quitting) accompanies the text.
Messages are pushed to participants 1-2 times/day, with 24/7 access to messages pulled from 3 keywords (HELP1, JONES, SLIP).
Participants also receive inquiry texts, designed to push videos of interest/relevance to the individual.
The cultural adaptations are infused throughout the video segments.
Topics include deep structure: race and smoking in general, African American smoking statistics; norms for smoking; concerns about nicotine replacement/medication; family/collectivism; unique stressors; racism/discrimination, depression; co-morbid addiction; neighborhood/environmental influences; menthol cigarettes; race-specific weight issues and concerns; and working as a community against the tobacco industry.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility as measured by interest in using Path2Quit video text program
Time Frame: Through study completion, an average of 6-weeks.
|
The program will be evaluated as feasible if 50% of those screened are eligible and interested in the video text program AND if 90% of those who are eligible and interested in the video text program will be able to engage in the program (some may need technical assistance).
|
Through study completion, an average of 6-weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability of intervention in terms of its Satisfaction and perceived helpfulness: 6-Week Follow-Up Questionnaire
Time Frame: 6 weeks from end of intervention
|
Acceptability of intervention measured through a 6-Week Follow-Up Questionnaire assessing satisfaction with Path2Quit and perceived usefulness Program will be evaluated as 'acceptable' if 80% of those who engage in the video text program and who answer the follow-up survey will rate their satisfaction with program and usefulness of the program at 3 or higher (on 0-7 scale where 3 indicates somewhat satisfied and somewhat useful) AND 80% rate the likelihood that they would recommend to a friend at a 3 or higher (on 0-7 point scale where 3 indicates "yes, I think so"). |
6 weeks from end of intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CASE1Y19
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Tobacco Use Cessation
-
University of Mississippi Medical CenterNot yet recruitingTobacco Cessation
-
Duke UniversityCompletedSmokeless Tobacco CessationUnited States
-
Claremont Graduate UniversityNational Cancer Institute (NCI)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, CigaretteUnited States
-
Mayo ClinicNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
-
Vanderbilt University Medical CenterCompletedTobacco Use | Tobacco Use Cessation
-
University of MiamiFlorida Department of HealthRecruitingSmoking Cessation | Tobacco Smoking | Tobacco Use CessationUnited States
-
University of California, San FranciscoTobacco Related Disease Research ProgramRecruitingTobacco Cessation | Tobacco Use | Tobacco Use Cessation | Tobacco Dependence | Tobacco AbstinenceUnited States
-
The University of Hong KongQueen Elizabeth Hospital, Hong Kong; Food and Health Bureau, Hong Kong; Queen... and other collaboratorsCompletedSmoking Cessation | Tobacco Use CessationHong Kong
-
Centre for Addiction and Mental HealthCompletedSmoking Cessation | Tobacco Use CessationCanada
-
SanofiCompletedSmoking Cessation | Tobacco Use CessationUnited States, Canada
Clinical Trials on Path2Quit - culturally specific text message intervention
-
Michigan State UniversityAmerican Cancer Society, Inc.Enrolling by invitationColorectal CancerUnited States
-
Wollo UniversityUnknownBehavioral Risks of Cancer
-
Dokuz Eylul UniversityActive, not recruitingType 2 Diabetes Mellitus (T2DM) | Patient Activation | Diabetes Self-management | Diabetes Mellitus (DM)Turkey
-
University of PennsylvaniaCompletedGestational Diabetes | Diabetes in Pregnancy | Texting InterventionsUnited States
-
Boston UniversityCompletedEating DisordersUnited States
-
Massachusetts General HospitalCompletedHypertension | Type2 Diabetes | HyperlipemiaUnited States
-
Samanta Winck MadrugaUnknown
-
Massachusetts General HospitalCompletedAcute Coronary SyndromeUnited States
-
Emory UniversityNational Cancer Institute (NCI)CompletedMalignant Solid Neoplasm | Hematopoietic and Lymphoid System NeoplasmUnited States
-
Universidad Peruana Cayetano HerediaCompleted