Integrating CHWs Into Prenatal Care for Maternal Smoking Cessation: A Pilot Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 105
- 试验地点
- 4
- 主要终点
- Self-Report Tobacco Abstinence
研究概览
简要总结
This develops a novel behavioral tobacco cessation program for pregnant smokers in San Bernardino County.
详细描述
This study seeks to address the disparities in the maternal smoking cessation outcomes of previous research by developing an innovative maternal tobacco cessation program that expands the outreach by integrating home visits by community health workers (CHW) into the prenatal healthcare model. The overall aim is to conduct a pilot randomized control trial to test the feasibility, acceptability, and efficacy of a Healthcare Provider-Community Health Worker (HCP-CHW) intervention model that expands outreach by adding eight home visits by CHWs to provide tobacco cessation support services before and after the quit date.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •< 24 weeks pregnant
- •age > 18 years,
- •current smokers (100 cigarettes in their lifetime and >3 cigarettes per day in the last 7 days; including poly-tobacco use, combining cigarettes with non-combustible products) confirmed by expired carbon monoxide (CO)
- •willing to quit smoking and set a quit date in the next 2 weeks upon enrolling
- •enrolled in prenatal care at Loma Linda University Health (LLUH) or Riverside University Health System (RUHS)
排除标准
- •severe mental health problems that prevent informed consent and/or CHW intervention
- •women who were on Nicotine Replacement Therapy (NRT) or enrolled in a cessation program within 30 days
- •unwillingness to participate in audio-recorded key informant interviews or focus groups
研究组 & 干预措施
Control arm
Standard of Care
干预措施: Control Arm (Other)
Integrated HCP-CHW Intervention Arm
CHW visit with brief tobacco cessation intervention.
干预措施: HCP-CHW Integration into Prenatal Care for Smoking Cessation (Behavioral)
结局指标
主要结局
Self-Report Tobacco Abstinence
时间窗: Change between baseline enrollment and 1 month postpartum visit, typically ten months
The 7 Day Point Prevalence Abstinence (PPA) questionnaire will be administered to subjects to assess the following: Tobacco use within past seven days
次要结局
- Carbon Monoxide Level(Change between baseline and 1 month postpartum visit, typically ten months)
- Arm 1 Satisfaction with CHW visit(Baseline; during the intervention; through study completion, an average of 10 months.)