Intervention Study to Increase Smoking Cessation Rates Among Public Housing Residents

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Boston University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Harvard School of Public Health
The Miriam Hospital
Boston Housing Authority
Information provided by (Responsible Party):
Boston University
ClinicalTrials.gov Identifier:
NCT01651611
First received: July 24, 2012
Last updated: July 26, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Tobacco Cessation
Behavioral: Motivational interviewing
Behavioral: Smoking cessation counseling
Behavioral: Navigation to smoking cessation resources
Behavioral: Social support

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Health Advocates as a Vehicle to Improve Treatment for Smokers in Public Housing

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • Point prevalence smoking abstinence [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    7 and 30-day abstinence from smoking by self-report with verification by carbon monoxide breath test


Secondary Outcome Measures:
  • Utilization of smoking cessation resources [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    Use of SQL, smoking cessation programs at health clinics or hospitals, physician counseling


Other Outcome Measures:
  • Medication use [ Time Frame: 3 months, 7 months, 12 months ] [ Designated as safety issue: No ]
    Use of nicotine replacement therapy and/or other smoking cessation medications


Estimated Enrollment: 500
Study Start Date: September 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Extensive TTA interaction Behavioral: Motivational interviewing Behavioral: Smoking cessation counseling Behavioral: Navigation to smoking cessation resources Behavioral: Social support
Active Comparator: Minimal TTA interaction Behavioral: Smoking cessation counseling

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.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01651611

Contacts
Contact: Tegan C Evans, MPH 6174141391 tcevans@bu.edu
Contact: Jessica Davine, MPH/MSW 6176387726 jdavine@bu.edu

Locations
United States, Massachusetts
Boston University School of Public Health Recruiting
Boston, Massachusetts, United States, 02118
Contact: Tegan C Evans, MPH    617-414-1391    tcevans@bu.edu   
Contact: Jessica Davine, MPH/MSW    6176387726    jdavine@bu.edu   
Principal Investigator: Daniel Brooks, DSc/MPH         
Sponsors and Collaborators
Boston University
Harvard School of Public Health
The Miriam Hospital
Boston Housing Authority
Investigators
Principal Investigator: Daniel R Brooks, DSc Boston University
  More Information

No publications provided

Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT01651611     History of Changes
Other Study ID Numbers: H-28386, 1R01CA141587-03
Study First Received: July 24, 2012
Last Updated: July 26, 2012
Health Authority: United States: Federal Government

Keywords provided by Boston University:
Tobacco Cessation
Public Housing
Community Health Workers
Motivational Interviewing
Patient centered
Low-income
Tobacco Treatment Advocates
Social Epidemiology
Smoking cessation predictors
Behavioral Intervention
Non-pharmacologic

ClinicalTrials.gov processed this record on September 16, 2014