Adaptation and Testing of a Novel Text-based Tobacco Cessation and Education Intervention in Kenyan Emergency Department Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 285
- 试验地点
- 1
- 主要终点
- Exhaled Carbon Monoxide testing to assess efficacy
研究概览
简要总结
In this study, investigators will adapt and implement Text2Quit in a Kenyan ED population will increase knowledge and cessation. Investigators will use a mixed-methods, hybrid implementation-effectiveness approach to assess these outcomes. Results will inform a randomized, controlled trial in a nationally representative sample of EDs in future. This study will be the first to target tobacco use in this population, the first to use mobile cessation, and will contribute to advancing implementation science on tobacco cessation globally. It will also provide a novel approach to implementation for mHealth interventions, with findings that can be generalized to other Non-Communicable Diseases and risk factors, such as alcohol use, hypertension and diabetes.
详细描述
Aim 1. To assess tobacco use and willingness to engage with mHealth for tobacco cessation targeting Kenyan ED patients.
Aim 2. To adapt the Text2Quit mHealth tool for use in the Kenya context using a participatory approach.
Aim 3. To pilot test Text2Quit-Kenya and assess its acceptability, feasibility, and efficacy.
The focus of this registration is Aim 3.
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
- 否
入选标准
- •Current tobacco users (self-identified smokers).
- •Presenting to the Emergency Department (ED) at Kenyatta National Hospital (KNH).
- •Own a mobile phone capable of receiving text messages.
- •Willing to quit tobacco use.
- •Able and willing to provide informed consent.
排除标准
- •Individuals unwilling or unable to provide consent.
- •Non-tobacco users.
- •Those without access to a mobile phone.
- •Patients who are critically ill or otherwise unable to participate (practically excluded at triage).
研究组 & 干预措施
Control
Standard of care
Text2Quit Kenya
Participants will receive the Text2Quit intervention
干预措施: Text2Quit-Kenya (Other)
结局指标
主要结局
Exhaled Carbon Monoxide testing to assess efficacy
时间窗: Baseline, Month 1 and Month 6
Efficacy will be assessed by repeat exhaled Carbon Monoxide testing. Will be assessed using both a binary assessment with a cutoff of 10% and a continuous assessment of percent point prevalence
Text2Quit Survey to assess efficacy
时间窗: Baseline and 1 Month post intervention
Efficacy will be assessed by self-report binary quantitative outcome of tobacco use in past 7 days
次要结局
- Percent enrollment(Baseline)
- Tobacco Use Frequency(Baseline and Month 1)
- Adoption assessed using Adoption RE-AIM Framework(up to Month 6)
- Facililtators -Implementation(up to Month 6)
- Barriers-Implementation(up to Month 6)
- Frequency of message delivery(up to Month 6)
- Frequency of message read(Baseline, Month 1 and Month 6)
- Frequency of response(up to Month 6)
- Maintenance assessed using RE-AIM Framework(Month 6)
- Cost(Month 6)
- Tobacco Policies Knowledge(Baseline and Month 1)
- Tobacco Harms Knowledge(Baseline and Month 1)
- Mean Tobacco Cessation Attempts(Baseline and Month 1)
- Absolute Number Tobacco Cessation Attempts(Baseline and Month 1)