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Smoking Cessation Interventions for Quitting Smoking
N/A
Recruiting
Led By Steven Fu, MD, MSCE
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6, 12, and 18 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will test an approach to help BIPOC smokers access evidence-based, culturally tailored tobacco cessation treatments.
Who is the study for?
This trial is for BIPOC individuals who are part of the Hennepin Healthcare or MCHS system, speak English or Spanish, currently smoke cigarettes, and want to quit. They must have contact information in their health record. People with cognitive impairments or under legal guardianship, or those who've opted out of research can't participate.
What is being tested?
The study tests two methods to help BIPOC smokers quit: Ask-Advice-Connect (AAC) and Longitudinal Proactive Outreach (LPO). It aims to see if proactive outreach using these methods increases the use of evidence-based cessation treatments compared to standard care.
What are the potential side effects?
Since this trial focuses on smoking cessation approaches rather than medications, it may not have typical side effects. Participants might experience stress or discomfort related to quitting smoking.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6, 12, and 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6, 12, and 18 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
7-day point-prevalence smoking abstinence at 18 months
Secondary study objectives
Change in Overall Quality of Life
Change in Theory of Planned Behavior Questionnaire (TPB-Q) Score
Change in Treatment utilization.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: AAC + Longitudinal Proactive Outreach (LPO)Experimental Treatment2 Interventions
AAC+LPO participants will receive AAC plus an MI tailored outreach call at baseline and at 3, 6, and 9 months post-enrollment. AAC includes enhanced access to State Quitline and Nicotine Replacement Therapy.
Group II: Enhanced Usual Care: Ask-Advice-Connect (AAC)Active Control1 Intervention
AAC participants will receive care through their primary care provider as usual (with the caveat that providers in the clinics will be trained to provide AAC). AAC includes enhanced access to State Quitline and Nicotine Replacement Therapy.
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Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,439 Previous Clinical Trials
1,619,958 Total Patients Enrolled
Steven Fu, MD, MSCEPrincipal InvestigatorMinneapolis Veterans Affairs Medical Center
1 Previous Clinical Trials
64 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have chosen not to participate in any research studies.My health records show I have cognitive issues or I am under legal guardianship.
Research Study Groups:
This trial has the following groups:- Group 1: AAC + Longitudinal Proactive Outreach (LPO)
- Group 2: Enhanced Usual Care: Ask-Advice-Connect (AAC)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.