Libre Del Cigarrillo: Development of an mHealth Smoking Cessation App to Extend Reach of a Validated Smoking Cessation Intervention for Spanish-speaking Smokers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Usability - System Usability Scale
研究概览
简要总结
Pilot randomized controlled trial evaluating feasibility, acceptability, and trial-readiness of the new app compared with the existing print booklets and the NCI SmokefreeTXT en Español program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Self-identify as Hispanic/Latinx.
- •18+ Years of age.
- •Monolingual Spanish-speaking, or bilingual Spanish-English and prefer educational health materials in Spanish.
- •Have been smoking at least 5 cigarettes per week over the past year
- •Not currently enrolled in a face-to-face or virtual smoking cessation program.
排除标准
- •A household member enrolled in the study.
- •Prior participation in the LDC randomized controlled trial.
- •Prior use of the NCI SmokefreeTXT program.
研究组 & 干预措施
Arm 1: Smartphone app
Participants receive access to the finalized Libre del Cigarrillo smoking-cessation app.
干预措施: Libre del Cigarrillo Smartphone App (Behavioral)
Arm 3: SmokefreeTXT
Participants receive NCI's automated Spanish-language SmokefreeTXT text-messaging cessation program.
干预措施: SmokefreeTXT en Español (Behavioral)
Arm 2: Printed booklets
Participants receive the culturally tailored Libre del Cigarrillo printed self-help booklets.
干预措施: Libre del Cigarrillo Printed Booklets (Behavioral)
结局指标
主要结局
Usability - System Usability Scale
时间窗: Up to 18 Months
Participants' perceptions of the app's usability in the app arm will be measured using 10 items on a 5-point Likert Scale. Scores range from 0 to 100, with higher scores indicating better usability.
Acceptability - Client Satisfaction Questionnaire (CSQ)
时间窗: Up to 18 Months
Participants' satisfaction with the LDC app will be measured using the Client Satisfaction Questionnaire (CSQ). The questionnaire consists of 8 items rated on a 4-point Likert scale, with higher scores indicating greater overall satisfaction.
Feasibility - Screening Rate
时间窗: Up to 18 Months
Number of potential participants screened to participate in the study.
Feasibility - Enrollment Rate
时间窗: Up to 18 Months
Number of screened eligible participants who enroll in the study.
Feasibility - Baseline Assessment Completion
时间窗: Baseline
Number of enrolled participants who complete all baseline questionnaires.
Feasibility - Retention at 18 Months
时间窗: Up to 18 months
Number of participants in each of the arms that completed the 18-month follow-up assessment.
Feasibility - Biochemical Verification
时间窗: Up to 18 months
Number of participants self-reporting abstinence who returned saliva samples for cotinine verification.
次要结局
未报告次要终点