Intervention Study to Increase Smoking Cessation Rates Among Public Housing Residents

August 26, 2016 updated by: Boston University

Health Advocates as a Vehicle to Improve Treatment for Smokers in Public Housing

The purpose of this study is to determine whether public housing residents trained in Tobacco Cessation and Motivational Interviewing Techniques to become Tobacco Treatment Advocates(TTA) will be effective in increasing the quit rate of smokers in Boston Public Housing. The investigators hypothesize that smokers that receive multiple TTA visits will be more likely to (1) use smoking cessation resources and (2) quit compared to smokers who receive a single visit.

Study Overview

Detailed Description

The study is a group-randomized trial in which 10 pubic housing developments (PHDs) are randomized to the experimental condition and 10 to the control condition. All smokers who enroll in the study at a particular PHD receive the same intervention. Smokers at control sites receive written materials that offer strategies for quitting and information about availability of treatment programs, as well as a one-time meeting with a Tobacco Treatment Advocate (TTA). The intervention group receives the same written materials but also has much more extensive interactions with a TTA. TTAs provide peer counseling (Peer Counseling is defined as: performance of limited counselor functions, under counselor supervision, by person of similar age,gender, race, ethnicity and/or SES of the counselee) to smokers during in- person Motivational Enhancement meetings (target range 7-9) as well as additional in person and phone contacts, as needed for each participant, over a 6-month period. TTAs receive intensive training in motivational interviewing and smoking cessation counseling deliver the intervention components (counseling activities and provision of environmental supports) in addition to encouraging utilization of smoking cessation treatment programs such as the Smokers' QuitLine (SQL) and clinic-based programs. In order to avoid the potential for contamination due to TTAs interacting with participants at both intervention and control sites, meetings with participants at control sites are conducted by special Control TTAs. Data are collected from study participants at baseline, 3 months, 7 months and 12 months, and also from the SQL and clinics.

Study Type

Interventional

Enrollment (Actual)

330

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 Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston University School of Public Health

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

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Current smoker, defined as having smoked in last 100days
  • Housing Sites: Sites are eligible for the study if they have 50+ smokers determined by synthetic estimates based on citywide survey data.
  • Age 18-79
  • Current everyday or someday smokers
  • Planning to quit smoking in 30 days or thinking about quitting in next 6 months,
  • Have smoked 100 cigarettes in lifetime
  • Speak English or Spanish
  • Plan to live in Public Housing for next 12 months
  • Able and willing to provide consent

Exclusion Criteria:

  • Smokers less than 18 years of age at time of consent.
  • Unable to communicate orally in English or Spanish.
  • Currently using pharmacological treatment for smoking cessation
  • Currently working with the Smokers Quitline or other Community Health Center based cessation program
  • Cognitive/ psychiatric conditions that would interfere with ability to understand and participate in the study
  • Have been abstinent for 7 or more days.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Extensive TTA interaction
Persons interested in quitting smoking will receive multiple in-person visits from a peer Tobacco Treatment Advocate (TTA) who will provide motivational interviewing, basic smoking cessation counseling assistance, navigation to smoking cessation resources, and social support.
The TTA will use motivational interviewing (MI) techniques to assess the participant's motivation and readiness to quit, suggest plans, and assist the participant in selecting a method of treatment.
The TTA will provide information to the participant regarding evidence-based treatments for smoking cessation, including counseling and nicotine replacement therapy (NRT); assist in a quit plan; and discuss issues such as obtaining social support, staying in treatment, and dealing with lapses.
The TTA will assist participants in obtaining NRT and getting connected to smoking cessation counseling services, such as the Smokers' Quitline and clinic-based programs.
Meetings with the TTA will be a source of social support for the participant as they attempt to quit or stay quit.
Active Comparator: Minimal TTA interaction
Persons interested in quitting smoking will receive a single in-person visit from a peer Tobacco Treatment Advocate (TTA) who will provide basic smoking cessation counseling assistance.
The TTA will provide information to the participant regarding evidence-based treatments for smoking cessation, including counseling and nicotine replacement therapy (NRT); assist in a quit plan; and discuss issues such as obtaining social support, staying in treatment, and dealing with lapses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Point prevalence smoking abstinence
Time Frame: 7 months
7 and 30-day abstinence from smoking by self-report with verification by carbon monoxide breath test
7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Utilization of smoking cessation resources
Time Frame: 7 months
Use of SQL, smoking cessation programs at health clinics or hospitals, physician counseling
7 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication use
Time Frame: 3 months, 7 months, 12 months
Use of nicotine replacement therapy and/or other smoking cessation medications
3 months, 7 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Daniel R Brooks, DSc, Boston University

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

September 1, 2011

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

July 24, 2012

First Submitted That Met QC Criteria

July 26, 2012

First Posted (Estimate)

July 27, 2012

Study Record Updates

Last Update Posted (Estimate)

August 29, 2016

Last Update Submitted That Met QC Criteria

August 26, 2016

Last Verified

January 1, 2015

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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