SCH: INT: Harnessing the Power of Technology: MOMBA for Postpartum Smoking
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Acceptability
研究概览
简要总结
Through a smartphone platform, financial incentives for smoking abstinence in postpartum women can be delivered remotely, thus minimizing the need for participants to come to the office to receive traditional contingency management.
详细描述
The specific aims of the proposal are:
- To develop through a 15-month pilot study, a novel smartphone-based system, Momba Smoking, that can be used in further relapse prevention trials for postpartum smokers.
- To determine, through a pilot randomized controlled trial, the potential feasibility, acceptability, and methodological parameters that are necessary to design a subsequent, appropriately powered, randomized controlled trial of the Momba Smoking smartphone-based system.
- To advance discovery and understanding on the use of technology to translate smoking cessation interventions from clinical to community settings through the training of the next generation of scientists.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women who are over the age of 18
- •Speak English
- •Second or third trimester of pregnancy
- •Smoking in the third trimester of pregnancy
- •No complicating general medical or psychiatric conditions (including marijuana use).
排除标准
- •Receiving other smoking cessation medication
- •Planning to move out of New Haven in the next 15 months
- •Actively suicidal, psychotic or unable to provide informed consent
结局指标
主要结局
Acceptability
时间窗: 3 and 9 months
Primary Outcome - Acceptability of the delivery of financial incentives for smoking abstinence in postpartum women through a smartphone platform as compared to traditional, in office contingency management. Acceptability of the smartphone application to low-income, pregnant women defined by the percentage of women who would recommend the site to a friend. Question: "How likely is it that you would recommend MoMba LiveLong to a friend who wants to stop smoking?"
Enrollment Rate
时间窗: 15 months
Primary Outcome - Feasibility of the delivery of financial incentives for smoking abstinence in postpartum women through a smartphone platform as compared to traditional, in office contingency management. Feasibility: participation rate of \> 60% for eligible women between screening and enrollment. Number of women who were eligible from screening that completed an intake.
Remote Detection
时间窗: 15 months
Primary outcome is the correlation coefficient. The correlation coefficient was calculated between the piCO+™ and the Sensordrone™ specific to expired CO measurement and verified through urine cotinine levels. Data for all three instruments was collected during week 1 visits 1-5, 3 month, 9 month and 15 month assessments.
Visit Attendance / Challenge Completion
时间窗: 15 months
Primary Outcome - Feasibility of the delivery of financial incentives for smoking abstinence in postpartum women through a smartphone platform as compared to traditional, in office contingency management. Feasibility: challenge completion and in-office visit attendance to assess compliance. MoMba Contingency Management: Number of breath tests completed among participants who remained enrolled at the end of 12 weeks. Office Contingency Management: Number of breath tests (corresponds to office visits) completed among participants who remained enrolled at the end of 12 weeks.
Retention: Number of Participants Remaining in Study at 12 Weeks
时间窗: 15 months
Primary Outcome - Feasibility of the delivery of financial incentives for smoking abstinence in postpartum women through a smartphone platform as compared to traditional, in office contingency management. Feasibility: retention set at 80% for the Momba Smoking group. Number of participants in the intervention group (MoMba Contingency Management) and number of participants in the control group (office contingency management) who remained in the study at the end of contingency management (12 weeks).
次要结局
- Number of Participants With Short Term Abstinence From Smoking(3 months)
- Number of Participants With Long Term Abstinence From Smoking at 15 Month Follow-Up(15 months)
- Number of Participants With Long Term Abstinence From Smoking at 9 Month Follow-Up(9 months)