Intervention Study to Increase Smoking Cessation Rates Among Public Housing Residents

Tobacco Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01651611
• Other study ID #: H-28386
• Secondary ID: 1R01CA141587-03
• Status: Completed
• Phase: N/A
• First received: July 24, 2012
• Last updated: August 26, 2016
• Start date: September 2011
• Est. completion date: September 2014

Study information

• Verified date: January 2015
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Tobacco Cessation

Intervention

Behavioral:
• Motivational interviewing
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.
• Smoking cessation counseling
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.
• Navigation to smoking cessation resources
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.
• Social support
Meetings with the TTA will be a source of social support for the participant as they attempt to quit or stay quit.

Locations

Country	Name	City	State
United States	Boston University School of Public Health	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Boston University	Boston Housing Authority, Harvard School of Public Health, The Miriam Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Medication use	Use of nicotine replacement therapy and/or other smoking cessation medications	3 months, 7 months, 12 months	No
Primary	Point prevalence smoking abstinence	7 and 30-day abstinence from smoking by self-report with verification by carbon monoxide breath test	7 months	No
Secondary	Utilization of smoking cessation resources	Use of SQL, smoking cessation programs at health clinics or hospitals, physician counseling	7 months	No