A Community-based Trial of a Voluntary Smoke-free Home Intervention in Permanent Supportive Housing for Formerly Homeless Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 452
- 试验地点
- 2
- 主要终点
- Proportion of participants who adopt a smoke-free home voluntarily
研究概览
简要总结
The focus of this study is on expanding access to voluntary smoke-free homes to formerly homeless residents residing in permanent supportive housing and examining the impact of this intervention on reducing tobacco-caused disparities. In this study, the principal investigator will conduct a multi-site, community-based cluster-randomized wait-list controlled trial of the multi-faceted smoke-free home intervention among 400 permanent supportive housing residents residing in 20 permanent supportive housing sites across the San Francisco Bay Area with the goal of increasing voluntary adoption of smoke-free homes.
详细描述
PSH resident-participants (200 each in the intervention and wait-list control arms) and within each site (~20 participants at each site). All resident-participants will be informed about the study and invited to participate. Participants will be recruited within blocks of four housing sites per month, with each block containing two intervention and two wait-list control sites and anticipating roll-out of one such block per month. Anticipated completion of recruitment and enrollment of all resident-participants and staff-participants at the locations should occur within 6 months, allowing for a one-to-two-month extension to complete these activities. The intervention will be offered to the wait-list control participants once all participants in the intervention sites from the same block have completed their 6-month follow-up.
Within each site, study staff will advertise the study to residents the week prior to enrollment by placing flyers at the study site and making announcements at community meetings. After the informational meeting, study staff will be present at the recruitment sites during designated times to screen interested participants for eligibility and enroll eligible resident-participants into the study. These study procedures were successfully employed in the pilot study. Participants in the study may be invited to a one-time, voluntary, community advisory board (CAB) meeting.
Primary Objective:
I. Conduct a cluster randomized trial to estimate the effect of the smoke-free home intervention on resident-participants' voluntary adoption of smoke-free homes.
Exploratory Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or older
- •Ability to understand study procedures and to comply with them for the entire length of the study.
- •Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it.
- •Current smokers [(smoked at least 100 cigarettes in lifetime, daily or non-daily smoking in the past 7 days and at least 5 cigarettes per day, verified by expired Carbon Monoxide (CO)>= 8 parts per million (ppm) who smoke in their homes.
- •Expect to live in the PSH site for at least 12 months
- •English proficient.
排除标准
- •1. Contraindication to any study-related procedure or assessment.
研究组 & 干预措施
Smoke-free home permanent supportive housing (PSH) resident intervention + Staff Intervention
Study staff will deliver a one hour, one-on-one counseling to PSH resident-participants that includes: (1) a step-by-step guide on how to voluntarily adopt a smoke-free home, (2) information on second hand smoke (SHS) and third-hand smoke, alternative combustible tobacco and nicotine product use, cannabis-tobacco co-use, effects of SHS on kids and pets,(3) a worksheet on calculating personal costs related to tobacco use, and (4) pledges to designate one's home smoke-free. Staff at various sites will be trained by the study team (staff-participants) to provide support to the resident-participants in tobacco cessation. At follow-up assessments, the study team will ask resident-participants whether they had a chance to view the intervention materials in between visits and will offer an opportunity for resident-participants to discuss conflicts that they had experienced around smoke-free home adoption and will provide strategies to address these roadblocks.
干预措施: Resident counselling (Behavioral)
Smoke-free home permanent supportive housing (PSH) resident intervention + Staff Intervention
Study staff will deliver a one hour, one-on-one counseling to PSH resident-participants that includes: (1) a step-by-step guide on how to voluntarily adopt a smoke-free home, (2) information on second hand smoke (SHS) and third-hand smoke, alternative combustible tobacco and nicotine product use, cannabis-tobacco co-use, effects of SHS on kids and pets,(3) a worksheet on calculating personal costs related to tobacco use, and (4) pledges to designate one's home smoke-free. Staff at various sites will be trained by the study team (staff-participants) to provide support to the resident-participants in tobacco cessation. At follow-up assessments, the study team will ask resident-participants whether they had a chance to view the intervention materials in between visits and will offer an opportunity for resident-participants to discuss conflicts that they had experienced around smoke-free home adoption and will provide strategies to address these roadblocks.
干预措施: Staff Training (Behavioral)
Wait-List Control (Usual Care)
The current standard of care includes no interventions for smoke-free home adoption or referrals to smoking cessation resources. Wait-list group will be given the option to receive Smoke-Free Home (SFH) intervention after intervention group completes the 6-month follow-up. Staff at various sites will be trained by the study team (staff-participants) to provide support to the resident-participants in tobacco cessation.
干预措施: Staff Training (Behavioral)
结局指标
主要结局
Proportion of participants who adopt a smoke-free home voluntarily
时间窗: 6 months
Self-reported voluntary adoption of smoke-free homes for \>=90 days at 6 months follow-up
次要结局
- Proportion of participants who achieve abstinence(6 months)