Clinical Effort Against Smoke Exposure in Cystic Fibrosis (CEASE-CF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Intervention feasibility
研究概览
简要总结
The study will test the feasibility, acceptability, and preliminary efficacy of a multi-component smoking cessation intervention tailored to the needs of caregivers of children with CF and delivered in clinical settings as part of routine CF care. The ultimate goal of this effort is to reduce the exposure of children and adolescents with CF to tobacco smoke.
详细描述
This is a single-center, randomized, open-label study to test the feasibility and acceptability (primary outcomes) and preliminary efficacy (secondary outcome) of a multi-component smoking-cessation intervention delivered by a tobacco treatment specialist (TTS) integrated in the multidisciplinary CF care team.
The intervention will be tested in a two-group design with a 2:1 allocation. Participants (dyads of caregiver/CF child) will be randomized to either intervention or control group. The intervention group (N=24) will receive the multi-component intervention (intake assessment, follow-up, help with obtaining nicotine replacement therapy, and CF-specific smoke exposure education). The control group (N=12) will receive usual care plus CF-specific smoke exposure education.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult familial caregiver of a child with CF aged <18 years
- •Speak English
- •Report smoking at least 1 cigarette in the previous week
- •Not enrolled in a smoking cessation program
排除标准
- •Do not report smoking at least 1 cigarette in the previous week
- •Currently enrolled in a smoking cessation program.
研究组 & 干预措施
Intervention group
The intervention group will receive the multi-component intervention (counseling with intake assessment, follow-up, help obtaining nicotine replacement therapy, and CF-specific smoke exposure education)
干预措施: Tobacco Treatment Specialist (TTS) intervention (Behavioral)
Control group
The control group will receive usual care plus CF-specific smoke exposure education.
结局指标
主要结局
Intervention feasibility
时间窗: 6 months
Participant drop-out rates and time added to the clinical encounter
Intervention acceptability
时间窗: 6 months
Proportion of caregivers who accepted participation; Participant and provider satisfaction with the intervention on a 1-5 Likert scale; Perceived effectiveness of the intervention on a 1-5 Likert scale
次要结局
- Self-reported caregiver cessation(6 months)
- Child smoke exposure(6 months)
研究者
Gabriela R Oates
Assistant Professor
University of Alabama at Birmingham