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临床试验/NCT05181072
NCT05181072已完成不适用

Assessing the Effectiveness of Virtual Versus In-person Peer-motivation Smoking Cessation Interventions

Morgan State University1 个研究点 分布在 1 个国家目标入组 392 人开始时间: 2022年1月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
392
试验地点
1
主要终点
Self-reported smoking cessation verified by expired-air Carbon Monoxide (CO) level (virtual and in-person groups).

研究概览

简要总结

This study is a randomized community-based trial adapted to the needs of adults aged 21 years or older that is designed by an existing research partnership called Communities Engaged and Advocating for Smoke-free Environments (CEASE). The overarching goal of the proposed study is to apply a community-based approach to reduce tobacco use among low-income communities in Baltimore City. The study setting represents three underserved communities in Baltimore City: the Oldtown/Middle East, the Waverlies, Poppleton/The Terraces/Hollins Market, and Washington Village/Pigtown. Poppleton/The Terraces/Hollins Market and Washington Village/Pigtown will be considered as one community. The three communities have been randomly allocated to one of the three arms of the study: 1) Virtual intervention, 2) Enhanced in-person intervention, and 3) The control community.

The Waverlies was assigned to virtual, the Middle East was assigned to be the in-person group, and Poppleton/The Terraces/Hollins Market and Washington Village/Pigtown became the self-help/control group. The goal of the trial is to assess the effectiveness of virtual versus in-person versions of a smoking cessation program in terms of their success rates (quitting and staying quit). The study's primary hypothesis is that the smoking cessation rate will be equal to or higher in the virtual peer-motivation arm than the in-person and self-help/ control arms. The secondary hypothesis is that the retention rate will differ among the three interventions (virtual peer-motivation, enhanced in-person peer-motivation, and self-help/control community).

Virtual and enhanced in-person versions of the CEASE Today Peer-Motivation Intervention were developed and pilot-tested during the first and second years based on local data and input from partnering communities. The enhanced in-person intervention will utilize the existing CEASE Today Tobacco Cessation Manual with improvements. The virtual intervention will use a newly developed CEASE website with smoking cessation modules and lessons that mirror the CEASE Today Tobacco Cessation Manual. Trained peer-motivators will deliver the intervention and be actively involved in recruiting the participants, motivation enhancement, group facilitation, and counseling.

详细描述

The project will capitalize on the capacity of a long-term successful community-campus partnership to reduce tobacco-related health disparities through a mixed-method randomized community-based trial adapted to the needs of adults (>21 y/o). The smoking cessation classes will be conducted in community venues, including non-profit organizations, churches, schools, etc., in three underserved communities in Baltimore City. The three communities have been randomly allocated to one of the three arms of the study:

  1. Enhanced in-person intervention
  2. Virtual intervention
  3. The self-help/control community

CEASE Digital smoking cessation program is a seven-week program using the CEASE Today Tobacco cessation manual. Sessions during the first two weeks will be held in-person for both the virtual and enhanced in-person arms after which the subsequent sessions will be conducted either virtually or in-person for the respective arms. Week one will entail an orientation session. Following the screening, all eligible participants will be invited to the orientation session where the participants will be taken through the informed consent process. After completing the informed consent process, each participant will complete a baseline survey and take a carbon monoxide (CO) breath test. The participants will be given relevant introductory information about the CEASE Digital program.

In addition, participants will be given one month/30 days to set a quit date and will receive Nicotine Replacement Therapy (NRT) samples along with information about using NRT. Orientation packets, with relevant materials, will be provided to the participants and intervention site coordinators. In the second week, which will also be held in-person for all the participants, class information and technology training (using zoom and slack) will be provided. Participants will get an opportunity to practice accessing the program materials and /curriculum via the digital platforms. In addition, ground rules for the meetings will be set, including group meeting etiquette and maintaining confidentiality.

CEASE Today Tobacco Cessation program will commence in week three and will continue for a total of five sessions delivered weekly for five weeks. Smoking cessation classes (support groups) will be delivered either in-person or virtually. Each session will last for 2 hours, and trained peer-motivators will deliver the classes. Participants will be enrolled in groups of up to 10-15 individuals.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Individuals who are 21 years and above
  • •Current smokers
  • •Willing and ready to quit using tobacco, and consent to participate
  • •Access to devices (desktop, laptop, tablets, etc) with reliable and consistent internet access or cellular data (to participate in the virtual intervention)

排除标准

  • •Individuals who have health conditions preventing them from providing consent
  • •Individuals in communities randomized to the virtual intervention with no access to smartphones with internet access or cellular data

研究组 & 干预措施

Enhanced in-person peer-motivation

Experimental

This is a seven-week tobacco cessation program and will be offered in-person weekly for seven weeks and will utilize the CEASE Today Tobacco Cessation Manual.

干预措施: Enhanced in-person peer-motivation smoking cessation (Behavioral)

Virtual peer-motivation

Experimental

This is a seven-week tobacco cessation program and will be offered virtually (except first two sessions: orientation and technology set-up) weekly for seven weeks and will utilize a newly developed website with smoking cessation modules that mirrors lessons of the CEASE Today Tobacco Cessation Manual.

干预措施: Virtual peer-motivation smoking cessation (Behavioral)

Self-help/Control

No Intervention

The participants in the control group will receive the services already in place, including a brief motivation enhancement session.

结局指标

主要结局

Self-reported smoking cessation verified by expired-air Carbon Monoxide (CO) level (virtual and in-person groups).

时间窗: week19 from enrollment (12 weeks after the last peer-motivation session)

Self-reported smoking cessation verified by expired-air Carbon Monoxide (CO) levels. This will be measured using the CO breath monitor. Levels less than 8ppm will be considered as quit.

Self-reported smoking cessation verified by expired-air Carbon Monoxide (CO) level (self-help group).

时间窗: week12 from enrollment

Self-reported smoking cessation verified by expired-air Carbon Monoxide (CO) levels. This will be measured using the CO breath monitor. Levels less than 8ppm will be considered as quit.

次要结局

  • Retention(Week 7)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Payam Sheikhattari

Professor

Morgan State University

研究点 (1)

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