The SMOKE Telehealth Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Recruitment Feasibility
研究概览
简要总结
The goal of this clinical trial is to develop two health-focused interventions for tobacco smokers with chronic pain. The main questions it aims to answer are:
- Are the interventions feasible for delivery via telehealth?
- Are the interventions acceptable to participants?
This study has two phases. First, researchers will develop materials and receive feedback through three focus groups, updating the materials iteratively between each group. Next, researchers will compare the feasibility and acceptability of the two interventions.
Participants in the second phase will:
- Complete the a single-session telehealth intervention online
- Complete surveys online before, immediately after, and at 2-weeks, 1-month, and 3-months after the intervention session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •moderate to severe chronic pain
- •current daily tobacco smoking
- •willing and able to complete study components in English
- •adult (age 18 or over)
排除标准
- •planning or currently attempting to quit
- •recent use of cessation treatments or other products to quit smoking
研究组 & 干预措施
Smoking and Health Intervention 1
干预措施: Smoking and Health Telehealth Intervention 1 (Behavioral)
Smoking and Health Intervention 2
干预措施: Smoking and Health Telehealth Intervention 2 (Behavioral)
结局指标
主要结局
Recruitment Feasibility
时间窗: At the participant level, time from screening through enrollment is anticipated to be up to 4 weeks. The total will be calculated at the end of the entire enrollment period of the study, which is anticipated to be approximately 1 year and 9 months.
Enroll \>80% or more of people who meet eligibility criteria.
Intervention Delivery Feasbility
时间窗: At the participant level, intervention delivery occurs in the same session as enrollment. Overall feasibility will be assessed at the end of the entire enrollment period, which is anticipated to be 1 year and 9 months.
Delivery of the allocated intervention to at least 95% of enrolled participants.
Acceptability
时间窗: Immediately post intervention (at the end of the intervention session).
Mean scores for each item on the Client Satisfaction Questionnaire (CSQ) of 3 or greater. Mean total CSQ score of 24 or greater.
次要结局
- Cessation Motivation(Assessed immediately before and after the intervention (during the interventions session), and at 2-weeks, 1-month, and 3-months after the intervention session)
- Motivation for Cessation Treatment(Assessed immediately before and after the intervention (during the interventions session), and at 2-weeks, 1-month, and 3-months after the intervention session)
- Cessation Treatment Engagement(2-week, 1-month, 3-month follow-up)
- Pain and Smoking Inventory(Assessed immediately before and after the intervention (during the interventions session), and at 2-weeks, 1-month, and 3-months after the intervention session)
- Pain and Smoking Questionnaire(Assessed immediately before and after the intervention (during the interventions session), and at 2-weeks, 1-month, and 3-months after the intervention session)
研究者
Emily Zale
Assistant Professor
Binghamton University