Tobacco CessationNCT01651611
Intervention Study to Increase Smoking Cessation Rates Among Public Housing Residents
A study testing Motivational interviewing, Smoking cessation counseling and Navigation to smoking cessation resources in people with Tobacco Cessation, run by Boston University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Cessation
- What is being tested?
- Motivational interviewing, Smoking cessation counseling and Navigation to smoking cessation resources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Speak English or Spanish
- Plan to live in Public Housing for next 12 months
- Able and willing to provide consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University School of Public Health
Boston, Massachusetts, 02118
About this study
Official title: 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.
Read the 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.
- Conditions
- Tobacco Cessation
- Being tested
- Motivational interviewing, Smoking cessation counseling, Navigation to smoking cessation resources, Social support
- Keywords
- 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
- Medical subject headings
- Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewingBehavioural
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 counselingBehavioural
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 resourcesBehavioural
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 supportBehavioural
Meetings with the TTA will be a source of social support for the participant as they attempt to quit or stay quit.
| Study group | Role | What they receive |
|---|---|---|
| Extensive TTA interaction | Experimental | 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. Receives: Behavioral: Motivational interviewing; Behavioral: Smoking cessation counseling; Behavioral: Navigation to smoking cessation resources; Behavioral: Social support |
| Minimal TTA interaction | Active comparator | 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. Receives: Behavioral: Smoking cessation counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Point prevalence smoking abstinence
7 and 30-day abstinence from smoking by self-report with verification by carbon monoxide breath test
Measured: 7 months
Secondary outcomes (1)
Utilization of smoking cessation resources
Use of SQL, smoking cessation programs at health clinics or hospitals, physician counseling
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study startSep 2011
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco CessationStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH), The Miriam Hospital, Boston Housing Authority
- Responsible party
- Sponsor
- Investigators
- Daniel R Brooks, DSc, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651611
- Sponsor's protocol ID
- H-28386
- Other IDs
- 1R01CA141587-03
- Status last verified
- Jan 2015
- First submitted
- 24 Jul 2012
- Last updated
- 29 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Advocates as a Vehicle to Improve Treatment for Smokers in Public Housing
- ClinicalTrials.gov ID
- NCT01651611
- Acronym / sponsor ID
- H-28386
- Conditions
- Tobacco Cessation
- Keywords
- Tobacco Cessation, Public Housing, Community Health Workers, Motivational Interviewing, Patient centered, Low-income, Tobacco Treatment Advocates, Social Epidemiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH), The Miriam Hospital, Boston Housing Authority
- Study start
- Sep 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 27 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extensive TTA interaction | Experimental | Behavioral: Motivational interviewing, Behavioral: Smoking cessation counseling, Behavioral: Navigation to smoking cessation resources, Behavioral: Social supportPersons 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. |
| Minimal TTA interaction | Active comparator | Behavioral: Smoking cessation counselingPersons 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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational interviewingThe 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. | Behavioural | Extensive TTA interaction |
| Smoking cessation counselingThe 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. | Behavioural | Extensive TTA interaction, Minimal TTA interaction |
| Navigation to smoking cessation resourcesThe TTA will assist participants in obtaining NRT and getting connected to smoking cessation counseling services, such as the Smokers' Quitline and clinic-based programs. | Behavioural | Extensive TTA interaction |
| Social supportMeetings with the TTA will be a source of social support for the participant as they attempt to quit or stay quit. | Behavioural | Extensive TTA interaction |
Primary outcome
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
1 secondary outcome
Utilization of smoking cessation resources
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel R Brooks, DSc principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interviewing, Smoking cessation counseling and Navigation to smoking cessation resources in people with Tobacco Cessation, run by Boston University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Point prevalence smoking abstinence (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2016.