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临床试验/NCT03187730
NCT03187730已完成4 期

Integrating Financial Management Counseling and Smoking Cessation Counseling to Reduce Health and Economic Disparities in Low-Income Immigrants

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 410 人开始时间: 2017年9月22日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
410
试验地点
1
主要终点
% of Participants Who Had Smoked Cigarette(s) in the Past 7 Days (at 6 Months From Baseline)

研究概览

简要总结

This is a 24 month pilot project that will implement and evaluate an innovative program that integrates financial counseling with smoking cessation counseling for low-income immigrants.

详细描述

This is a two-arm randomized, wait-list control study with 610 participants total: 600 patient participants and 10 staff participants. 600 smokers will be recruited to complete a 9-week intervention that integrates financial management and smoking cessation counseling. Participants will be randomized (300 per arm, stratified by site) to receive the intervention immediately after enrolling (Intervention Arm) or 6 months later (Waitlist Control Arm). Both arms will receive nicotine replacement therapy (NRT) for four weeks as part of their time in integrative counseling. Participants will be observed at baseline, 2 months, 6 months and 12 months to assess outcomes and their satisfaction with treatment.

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

入选标准

  • Smokes ≥5 cigarettes per day
  • Born outside the U.S.
  • Interested in receiving smoking and financial counseling
  • Self-reported income below 200% of the current federal poverty level for a given household composition
  • New York City resident
  • English or Spanish language
  • Able to provide informed consent, and
  • Does not have a representative who manages his/her funds (to ensure the participant has the ability to manage household money). We will exclude participants who report being pregnant or breastfeeding (unable to receive NRT).
  • Hospital staff participants:
  • Must be current medical or non-medical provider or administrator at Bellevue Hospital or New York University Lutheran Medical Center

排除标准

  • We will exclude participants who report being pregnant or breastfeeding.

研究组 & 干预措施

Waitlist Control

Placebo Comparator

干预措施: Nicotine Replacement Therapy (NRT) (Drug)

Intervention Arm

Active Comparator

干预措施: Integrated Smoking Cessation and Financial Counseling (Behavioral)

Intervention Arm

Active Comparator

干预措施: Nicotine Replacement Therapy (NRT) (Drug)

Waitlist Control

Placebo Comparator

干预措施: Waitlist Integrated Smoking Cessation and Financial Counseling (Behavioral)

结局指标

主要结局

% of Participants Who Had Smoked Cigarette(s) in the Past 7 Days (at 6 Months From Baseline)

时间窗: 6 Months

Participants answered "In the past 7 days, have you smoked a cigarette? (yes/no)"; % of "yes" is reported per arm

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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