Integrating Financial Coaching and Smoking Cessation Coaching for People With Low Income Who Smoke: a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 602
- 试验地点
- 1
- 主要终点
- Effectiveness of the integrated intervention to standard cessation counseling on long-term abstinence (salivary cotinine)
研究概览
简要总结
This study conduct a two-arm, parallel-group randomized controlled trial. The study will recruit and randomize 900 smokers (n=450 per arm) to either: (1) Control: Standard Smoking Cessation Counseling or (2) Intervention: Integrated Financial-Smoking Cessation Counseling.
详细描述
The study is a two-arm, parallel-group RCT. The study will recruit and randomize 900 low-income smokers (n=450 per arm) to either: (1) Control: Standard Smoking Cessation Counseling or (2) Intervention: Integrated Financial-Smoking Cessation Counseling. Both groups will receive 8 weeks of nicotine replacement therapy. The study will survey participants at baseline, 6 months, and 12 months to assess outcomes and mechanisms, and biochemically verify self-reported abstinence at 12 months (our primary outcome). The study will assess and compare the costs and cost-per-quit in the two treatment arms.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age ≥18 years,
- •smokes ≥5 cigarettes per day,
- •interested in receiving smoking and financial counseling,
- •self-reported income below 200% of the current federal poverty level,
- •New York City resident,
- •speaks English or Spanish language (the interventions and measures have not been validated in other languages),
- •able to provide informed consent, and
- •does not have a representative who manages his/her funds.
排除标准
- •people who know a current past study participant (to avoid intervention contamination)
- •People who have a medical contraindication to using nicotine replacement therapy:
- •allergy to nicotine patch
- •pregnancy or intention to become pregnant over the next 12 months
- •breastfeeding
- •heart attack in the past 2 months
- •underlying arrhythmia
- •ongoing or worsening angina.
研究组 & 干预措施
Standard Smoking Cessation Coaching
Participants will receive 5 counseling sessions over approximately 8 weeks as per standard smoking cessation programs. Participants will receive 8 weeks of nicotine replacement therapy (patches, gum, and/or lozenges).
干预措施: Nicotine Replacement Therapy Agent - Gum (Drug)
Integrated Financial-Smoking Cessation Coaching
The integrated intervention will provide 5 counseling sessions over approximately 8 weeks that integrates financial coaching into the smoking cessation program. Participants will receive 8 weeks of nicotine replacement therapy (patches, gum, and/or lozenges).
干预措施: Financial counseling (Other)
Integrated Financial-Smoking Cessation Coaching
The integrated intervention will provide 5 counseling sessions over approximately 8 weeks that integrates financial coaching into the smoking cessation program. Participants will receive 8 weeks of nicotine replacement therapy (patches, gum, and/or lozenges).
干预措施: Nicotine Replacement Therapy Agent - Gum (Drug)
Integrated Financial-Smoking Cessation Coaching
The integrated intervention will provide 5 counseling sessions over approximately 8 weeks that integrates financial coaching into the smoking cessation program. Participants will receive 8 weeks of nicotine replacement therapy (patches, gum, and/or lozenges).
干预措施: Nicotine Replacement Therapy Agent - Lozenges (Drug)
Integrated Financial-Smoking Cessation Coaching
The integrated intervention will provide 5 counseling sessions over approximately 8 weeks that integrates financial coaching into the smoking cessation program. Participants will receive 8 weeks of nicotine replacement therapy (patches, gum, and/or lozenges).
干预措施: Nicotine Replacement Therapy Agent - Patches (Drug)
Standard Smoking Cessation Coaching
Participants will receive 5 counseling sessions over approximately 8 weeks as per standard smoking cessation programs. Participants will receive 8 weeks of nicotine replacement therapy (patches, gum, and/or lozenges).
干预措施: Nicotine Replacement Therapy Agent - Lozenges (Drug)
Standard Smoking Cessation Coaching
Participants will receive 5 counseling sessions over approximately 8 weeks as per standard smoking cessation programs. Participants will receive 8 weeks of nicotine replacement therapy (patches, gum, and/or lozenges).
干预措施: Nicotine Replacement Therapy Agent - Patches (Drug)
结局指标
主要结局
Effectiveness of the integrated intervention to standard cessation counseling on long-term abstinence (salivary cotinine)
时间窗: 12 months
The study will collect salivary cotinine from participants reporting 7-day abstinence from cigarettes on the 12-month survey. The study will use a saliva collection kit supplied by Salimetrics Inc. Participants will be classified as negative for salivary cotinine if their concentration is \<10ng/ml,
Effectiveness of the integrated intervention to standard cessation counseling on long-term abstinence (CO concentration)
时间窗: 12 months
The study will collect exhaled CO from participants reporting 7-day abstinence from cigarettes on the 12-month survey. The study will use a coVita Co monitor that provides an immediate CO concentration reading in single parts per million (ppm). Participants will be classified as negative for exhaled CO if their concentration is \<8 ppm.
次要结局
- Change in quit attempts(6 and 12 months)
- Change in self-reported abstinence from cigarettes(6 and 12 months)
- Change in self-reported use of electronic nicotine delivery systems use(6 and 12 months)