Engagement With an Adaptive Mobile Health Smoking Cessation Intervention
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Number of Participants With Self-reported 7-day Abstinence From Smoking at 12 Weeks
研究概览
简要总结
This is a pilot sequential multiple assignment trial (SMART) to understand the optimal timing to assess response to our smoking cessation text message intervention and to measure how adding medications alone compares to adding medications and telephone coaching for those who continue to smoke. This study aims to assess the feasibility of a SMART of a proactively offered text message intervention for smokers in primary care that compares early (4 weeks) versus late (8 weeks) assessment of treatment response and the addition of nicotine replacement therapy (NRT) alone or with telephone coaching for non-responders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •Adults (≥18 years)
- •Smoking status of current smoker in structured field of electronic health record (EHR)
- •Language listed as English in EHR
- •Massachusetts General Hospital patient, Partners healthcare primary care provider (PCP)
- •PCP visit in the past 2 years
- •Mobile telephone number listed in EHR
排除标准
- •Not a current daily smoker defined as not having smoked ≥100 cigarettes in lifetime or self-report of less than daily current smoking
- •Pregnant, planning to become pregnant in the next 3 months, or breastfeeding.
- •Past 30-day use of nicotine replacement therapy, bupropion, or varenicline.
- •Past 30-day use of Massachusetts state quit-line or SmokefreeTXT programs
- •Prior serious adverse reaction to the nicotine patch or lozenge defined as any reaction that was life-threatening, required hospitalization, or other clinical evaluation
- •Ever had an allergy to nicotine patch
- •Weight < 100 pounds
- •Unstable coronary disease
- •Unstable arrhythmia
- •Dementia or active psychosis or schizoaffective disorder
- •Willing and able to receive and participate with a text message program for up to 12 weeks
- •Unable to read English or unable to write English
研究组 & 干预措施
Early assessment
Patients are assessed for response to brief telephone advice plus a tailored text message program at 4 weeks post-randomization. Response is based on self-reported 7-day point prevalence abstinence. Non-responders are randomized to 4 weeks of mailed nicotine patches and/or lozenges (NRT) or 4 weeks of mailed NRT plus proactive telephone coaching.
干预措施: Brief telephone advice plus tailored text messages (Behavioral)
Early assessment
Patients are assessed for response to brief telephone advice plus a tailored text message program at 4 weeks post-randomization. Response is based on self-reported 7-day point prevalence abstinence. Non-responders are randomized to 4 weeks of mailed nicotine patches and/or lozenges (NRT) or 4 weeks of mailed NRT plus proactive telephone coaching.
干预措施: Mailed nicotine replacement therapy (Drug)
Early assessment
Patients are assessed for response to brief telephone advice plus a tailored text message program at 4 weeks post-randomization. Response is based on self-reported 7-day point prevalence abstinence. Non-responders are randomized to 4 weeks of mailed nicotine patches and/or lozenges (NRT) or 4 weeks of mailed NRT plus proactive telephone coaching.
干预措施: Proactive telephone coaching (Behavioral)
Late assessment
Patients are assessed for response to brief telephone advice plus a tailored text message program at 8 weeks post-randomization. Response is based on self-reported 7-day point prevalence abstinence. Non-responders are randomized to 4 weeks of mailed nicotine patches and/or lozenges (NRT) or 4 weeks of mailed NRT plus proactive telephone coaching.
干预措施: Brief telephone advice plus tailored text messages (Behavioral)
Late assessment
Patients are assessed for response to brief telephone advice plus a tailored text message program at 8 weeks post-randomization. Response is based on self-reported 7-day point prevalence abstinence. Non-responders are randomized to 4 weeks of mailed nicotine patches and/or lozenges (NRT) or 4 weeks of mailed NRT plus proactive telephone coaching.
干预措施: Mailed nicotine replacement therapy (Drug)
Late assessment
Patients are assessed for response to brief telephone advice plus a tailored text message program at 8 weeks post-randomization. Response is based on self-reported 7-day point prevalence abstinence. Non-responders are randomized to 4 weeks of mailed nicotine patches and/or lozenges (NRT) or 4 weeks of mailed NRT plus proactive telephone coaching.
干预措施: Proactive telephone coaching (Behavioral)
结局指标
主要结局
Number of Participants With Self-reported 7-day Abstinence From Smoking at 12 Weeks
时间窗: 12 weeks post-randomization
7-day point prevalence abstinence (0, abstinent; 1, smoking), measured as "Have you smoked cigarettes, even a puff, in the past seven days?"
次要结局
- Number of Participants With Self-reported 7-day Abstinence From Smoking at 8 Weeks(8 weeks post-randomization)
- Self-reported Change in Average Number of Cigarettes Smoked Per Day(12 weeks post-randomization)
- Exhaled Carbon Monoxide Less Than 8 Parts Per Million(12 weeks post-randomization)
- Self-reported Number of Days Nicotine Lozenge and/or Patch Used(12 weeks post-randomization)
研究者
Gina Kruse
Assistant Professor
Massachusetts General Hospital