A Scalable e-Health Smoking Cessation Intervention for Socioeconomically Disadvantaged Veterans
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Satisfaction With Assigned Treatment
研究概览
简要总结
This phase I trial studies how well a new electronic (e)-health smoking cessation program (called Vet Flexiquit) works in promoting smoking cessation in low-income veterans who may or may not be ready to quit smoking. The study will compare the new website smoking cessation program to the current standard care website smoking cessation program offered by the Veterans Administration (VA). Both website interventions will be accompanied by a text messaging program that includes: (1) motivational messages, and (2) reminders to use the assigned program. Both of the website interventions can help smokers quit or cut back on how much they smoke, thus dramatically reducing their chances of developing tobacco-related health conditions.
详细描述
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants use the new website smoking cessation program, which provides values driven, mindfulness based coping skills and utilizes non-judgmental acceptance of uncomfortable internal states like cravings. Participants also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with handouts and available resources provided by the VA for continued support for smoking cessation.
ARM II: Participants use the VA standard of care website, which provides educational materials about cessation treatments, tools to cope with urges and relapse, how to stay motivated, and brief tips on coping with physical and mental health problems. Participants also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with a handout of available resources provided by the VA for continued support for smoking cessation.
After study randomization, participants are followed up at 1 and 3 months.
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
- Double (Participant, Investigator)
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
- •Participants must be a US veteran
- •Participants must be low-income, as defined by falling below Veterans Health Administration (VHA) national income threshold for no-cost healthcare
- •Participants must be a current smoker, averaging at least 5 cigarettes/day for the last 30 days
- •Participants must have weekly internet access for the next 3 months
- •Participants must self-report current use of a personal email address to receive the link to their assigned web site
- •Participants must self-report being willing to complete all study activities
- •Participants must be willing to receive study-related text messages
排除标准
- •Currently taking part in any other smoking cessation treatment such as the nicotine patch, nicotine gum, Zyban, in-person counseling, telephone counseling, using a web-based or app-based cessation program
- •Have recent (past 30 days) substance use disorder, suicidal ideation, or psychiatric hospitalization
- •Previous participation in the treatment development stage of the new smoking cessation website program
- •Prior use of the SmokefreeVET web site
- •Member of the same household as another research participant
- •Woman who is pregnant or breastfeeding, or planning to become pregnant
结局指标
主要结局
Satisfaction With Assigned Treatment
时间窗: At 3 months post-randomization
Satisfaction ratings regarding the usefulness of specific components of the website program, user comments and suggestions for improvement, presented descriptively. Treatment satisfaction items are reported on a Likert-type scale, with response choices ranging from "not at all satisfied" to "very satisfied". Will dichotomize values at a threshold of "somewhat satisfied" or higher. We tested for differences between arms using a Fisher's Exact test.
Number of Server-recorded Logins to Assigned Website
时间窗: At 3 months
Will use negative binomial regression with adjustment for the stratification variable and baseline readiness to quit (high versus low) to compare treatment effects on the count outcome number of logins. There were no potential confounders to adjust for.
Duration of Website Use (Days Since First Login)
时间窗: At 3 months
Will use negative binomial regression with adjustment for the stratification variable baseline readiness to quit (high versus low) to compare treatment groups on the secondary acceptability outcome of duration of site usage (number of days elapsed from first to last use). There were no confounders to adjust for.
次要结局
- Self-reported Abstinence From All Nicotine and Tobacco Products (Except Nicotine Replacement Therapy)(In the 7 days prior to the 3-month follow up)
- Cotinine-confirmed, Self-reported Abstinence From Smoking(In the 30 days prior to the 3-month follow up)
- Number of Quit Attempts(At 3 months)
- Change in Readiness to Quit(Baseline up to 3-month follow-up)
- Change in Acceptance of Smoking Triggers(Baseline up to 3-month follow-up)
研究者
Jaimee Heffner
Associate Professor
Fred Hutchinson Cancer Center