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临床试验/NCT03099811
NCT03099811已完成不适用

Contingency Management for Controlling Secondhand Smoke Exposures Among Asthmatic Children

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 147 人开始时间: 2017年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
147
试验地点
2
主要终点
Pediatric secondhand smoke exposures

研究概览

简要总结

Secondhand smoke exposure (SHSe) is one of the most common and potentially modifiable environmental triggers for asthma. Financial incentivization may serve as an effective modality to reduce SHSe among pediatric asthmatics with potential down-stream benefits on improved asthma control and subsequent reduced healthcare utilization. This study plans on testing the feasibility and effectiveness of financial incentives to decrease SHSe, derived from primary caregivers and a member of their social network, of children with persistent asthma.

详细描述

The impact of continued cigarette usage is profoundly felt not only upon the primary smoker, but also among children where SHSe is linked with asthma exacerbations. Children with caregivers who are active smokers are more likely to utilize acute healthcare resources and miss more days of school due to asthma symptoms. Issues of pediatric smoke exposure are notably higher among low-income populations. This particular group has a greater amount of financial strain that increases their desire to cease smoking but is among the least successful at accomplishing this task. Aggressive marketing campaigns by cigarette companies have specifically targeted the urban poor but similar techniques by public health officials, though on a much diminished scale, have yet to completely counter the hold that this addictive product has on members of lower socioeconomic status. One approach that has demonstrated efficacy in reducing smoking in resistant populations emphasizes financial incentives. Incentives may provide a substitute for the gratification derived from nicotine if they are properly structured. This proposal applies a contingency management schema among caregivers of pediatric asthmatics and a member of their caregiver's social network - both of whom are likely major contributors to the child's total secondhand smoke exposure. A pilot two-arm randomized-control trial will be employed over a 6-month time interval.The study population will consist of the primary caregiver and a selected member of their social network, both of who are known active smokers, and contemplating smoking cessation; both individuals spend time (either indoors or outdoors) with the asthmatic child. We will recruit 50 caregiver-child-social network triads among a population of children diagnosed with uncontrolled, persistent asthma and routinely exposed to high levels of SHSe. Caregivers and members of their social network who are both active smokers will be randomized to receive standard smoking cessation strategies (n=25 triads) with or without financial incentives (n=25 triads). SHSe will be measured directly using salivary cotinine levels from children and home air nicotine levels. Caregiver and social network member smoking behaviors will be measured by nicotine biomarkers; both test results will be the basis for incentive payments. Asthma control will be evaluated using validated questionnaires and review of the participant's electronic health record.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
2 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Primary caregiver aged greater than 18 years who is an active smoker.
  • Child aged 2-12 years of age who meets clinical criteria for persistent asthma and has nicotine biomarker levels consistent with secondhand smoke exposure
  • Designated social network member who is an active smoker
  • Residence in Baltimore City

排除标准

  • Child has current diagnosis of another major pulmonary disease or other significant medical co-morbidity
  • Use of electronic cigarettes (e-cigarettes) by the adult-enrolled participants

研究组 & 干预措施

Intervention: Financial incentives + Smoking cessation program

Experimental

Caregiver and a social network member will receive financial incentives, in additional to enrollment in a state-sponsored smoking cessation program, based on nicotine biomarker measurements.

干预措施: Incentive plan (Behavioral)

Intervention: Financial incentives + Smoking cessation program

Experimental

Caregiver and a social network member will receive financial incentives, in additional to enrollment in a state-sponsored smoking cessation program, based on nicotine biomarker measurements.

干预措施: Smoking cessation (Behavioral)

Intervention: Smoking cessation program

Other

Caregiver and a social network member will be enrolled in a state-sponsored smoking cessation program.

干预措施: Smoking cessation (Behavioral)

结局指标

主要结局

Pediatric secondhand smoke exposures

时间窗: 6 months

Monthly measurement of pediatric secondhand smoke exposures. Secondhand smoke exposures will be measured using salivary cotinine levels.

次要结局

  • Air nicotine(6 months)
  • Nicotine biomarkers(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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