mHealth Messaging to Motivate Quitline Use and Quitting (M2Q2): RCT in Rural Vietnam
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Participant Tobacco Cessation Rate (Quit Rate) at 6 Months
研究概览
简要总结
The mHealth Messaging to Motivate Quitline Use and Quitting, or "M2Q2" study, is a collaborative research project for a mobile health intervention designed to motivate smoking cessation and encourage access to counseling. The study is for men and women smokers in Vietnam's Red River Delta region who are 18 years of age or older.
The primary hypothesis is that smokers in the M2Q2 intervention will have higher rates of smoking cessation, compared with the comparison group.
详细描述
The specific aims of the M2Q2 study are:
Aim 1: In collaboration with the Institute of Population, Health, and Development (PHAD) in Vietnam, adapt a current, effective messaging system to Vietnam. The messaging system will:
- Motivate smokers to quit smoking, using tailored messages adapted to be culturally relevant.
- Encourage smokers to accept counseling services from the Quitline, and take advantage of nicotine replacement therapy (NRT) that will be provided by the Quitline to those willing to quit.
Aim 2: To engage with the Quitline, providing additional training in tobacco cessation counseling for those ready to quit, and motivational interventions for those not yet ready to quit.
Aim 3: To evaluate the impact of the messaging system on: access to the Quitline, use of nicotine replacement therapy, increase in self-efficacy, and six-month biochemically verified smoking cessation.
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
- Single (Participant)
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
- •≥18 years of age.
- •Resident of a selected commune.
- •Be a current smoker.
- •Be able to receive texts and read text (literate).
- •Not be cognitively impaired (as assessed by study staff).
- •Not have helped develop messages used in the intervention.
- •Not be a family member of another participant in the study.
排除标准
- •<18 years of age.
- •Cognitively impaired (as assessed by study staff).
研究组 & 干预措施
Comparison
The comparison condition is designed as a minimal intervention, and allows for blinding of the patients to randomization group.
干预措施: Comparison (Behavioral)
Intervention
The intervention is designed to encourage and remind smokers of the availability of the Quitline services. In addition to the one-way motivational messages, the investigators will use two-way assessments. Two-way automated texting is the ability to push out a question, have the user respond with a brief, numeric or one-word answer, and based on that answer, provide immediate feedback. The goal of these brief assessments is two-fold: 1) to assess behavior (abstinence) and motivation to use services, and 2) to return feedback tailored to each individual smoker based on the answers of the user.
干预措施: Intervention (Behavioral)
结局指标
主要结局
Participant Tobacco Cessation Rate (Quit Rate) at 6 Months
时间窗: At 6 months post-randomization
7 day point prevalence cessation per self-report with additional carbon monoxide monitor verification for those who report cessation.
次要结局
- Change in Self-efficacy Scores Using the Self Efficacy Questionnaire (SEQ-12)(From randomization to 6 months post-randomization)
研究者
Rajani Sadasivam
Associate Professor, Population and Quantitative Health Sciences
University of Massachusetts, Worcester