Support Person Effectiveness Study to Promote Smoker Utilization of the QUITPLAN Helpline
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 1,020
- 试验地点
- 2
- 主要终点
- helpline utilization
研究概览
简要总结
This study is designed to examine if a telephone-based intervention delivered to a support person (i.e., friend, spouse of a smoker) increases the smoker's use of the Minnesota helpline. In addition, the study will examine if the rate of smoker calls to the helpline is greater if the support person receives 3 intervention calls, 1 intervention call, or no calls (written materials only, control condition).
详细描述
We will conduct a randomized clinical trial within the ongoing service of the QUITPLAN® Helpline. Our primary aim is to examine the efficacy of two levels of telephone counseling for support persons (1 or 3 sessions) compared with a control condition on the proportion of smokers who call the Helpline over the 7 month follow-up period. We hypothesize a dose response relationship between number of telephone sessions provided to the support persons and smoker calls to the Helpline. Additional aims are to examine smoker quit attempts and cessation, and cost-effectiveness of the interventions.
Nonsmoking adult support persons (N=1020) residing in Minnesota will be enrolled and randomly assigned to one of three study conditions: (1) control condition -written self-help materials, (2) written materials plus one telephone session, or (3) written materials plus three telephone sessions. Outcome assessments will be completed by support persons and smokers at post-treatment (week 4) and at 7 month follow-up.
This design will allow for evaluation of whether results from our previous trial (Patten et al., in press, AJPM) can be replicated when the intervention is implemented within a "real-world" setting. That is all support person intervention calls will be delivered by the Helpline. Moreover, we will examine the potential efficacy and cost-effectiveness of a streamlined version of the intervention (i.e., 1 call). Furthermore, the proposed study will provide new data on quit attempts and cessation among the smokers. Ultimately, positive findings from this line of research could serve as the basis for expanding the range of helpline services to nonsmokers.
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
- 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
- •The support person must
- •reside in Minnesota
- •be 18 years of age or older
- •provide written informed consent
- •be a never or former cigarette smoker (no cigarette smoking in the past 6 months)
- •want to support a current cigarette smoker (has smoked a total of >1 cigarettes during the past 7 days) who is 18 years of age or older, resides in Minnesota, and has not been enrolled in a helpline or any other cessation program in the last 3 months
- •be able and willing to participate in all aspects of the study
- •have access to a working telephone
- •have current and anticipated contact (any combination of face-to-face, telephone, text messaging, or electronic mail) with the smoker on at least 3 days a week for the 30 week study duration.
排除标准
- •Support persons will be excluded if another support person from the same household has enrolled.
结局指标
主要结局
helpline utilization
时间窗: At 7 month follow-up
smoker calls to the helpline
次要结局
- smoker quit attempts and cessation(7 month follow-up)
研究者
Christi Patten
Professor of Psychology
Mayo Clinic