Treating Nicotine Addiction in Caregivers of Children at American Family Children's Hospital
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Enrollment in study
研究概览
简要总结
The purpose of this research study is to 1) see if a smoking cessation program is something that caregivers will use while their child is hospitalized, 2) see if caregivers think this program is something we should institute across the hospital, and 3) see if this program can help caregivers reduce their smoking.
Participants will:
- Complete a survey regarding smoking behavior and thoughts about quitting;
- Undergo a 20-minute counseling session; and,
- Use nicotine patches and mini-lozenges for 2 weeks
详细描述
All participants will receive a one-time visit with the study physician. This visit will consist of a brief counseling session. Counseling sessions will last approximately 20 minutes and cover the 3 objectives of 1) review participants' motivation for smoking and for quitting; 2) use the information on participants' motives to provide tailored education regarding a) benefits of quitting smoking to the caregiver and the child, b) strategies to reduce nicotine withdrawal symptoms/urges to smoke during the hospitalization, and c) benefits of smoke-free home and car rules; and, 3) review smoking cessation resources.
After the counseling session, participants will be provided a 2-week supply of nicotine patches and nicotine mini-lozenges, along with instructions for their use. The study physician will review how to use the medication, dosing, benefits of use, and potential side effects of use.
Within 24 hours of discharge, participants will be contacted to complete a post-intervention survey, which will assess nicotine replacement therapy (NRT) use during the hospitalization and likelihood that the participant would recommend program implementation in the hospital. Smoking behavior during the child's hospitalization will be examined, including assessments of 1) number of cigarettes smoked per day and 2) number of times participant left the child's bedside to smoke per day. Participant's self-efficacy and interest in quitting smoking will be assessed, using the same questions from the pre-intervention survey, to assess for changes after the intervention.
Participants will be contacted 2 weeks after discharge with a link to complete the follow-up survey to again assess current smoking status, use of NRT post-hospitalization, self-efficacy and interest in quitting smoking, establishment of smoke-free home and car rules, and interest in ongoing smoking cessation treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Hospitalized child will have a 'yes' response to the screening question, "Does anyone in your household smoke"
- •Hospitalized child is expected to be admitted for >24 hours
- •Caregiver is at least 18 years of age
- •Participant self-identifies as the primary caregiver of the hospitalized child during the hospitalization
- •Participant smokes ≥5 cigarettes per day
- •Participant is willing and able to use NRT
- •Participant is not currently pregnant, trying to get pregnant, or breastfeeding and willing to use acceptable birth control for duration of medication use
- •Participant is willing to comply with all study procedures and be available for the duration of the study
排除标准
- •Contraindication to NRT use (pregnancy, myocardial infarction in past 2 weeks)
- •Previous reaction to the nicotine patch or mini-lozenge that prevented them from continuing to use it
- •Current use of smoking cessation medications (any NRT, bupropion, varenicline)
- •Caregiver's child is being cared for by study physician (Dr. Brian Williams)
- •Need for an interpreter
研究组 & 干预措施
Caregivers of hospitalized children
干预措施: Nicotine Replacement Product (Drug)
结局指标
主要结局
Enrollment in study
时间窗: Study recruitment, approximately 6 months
Enrollment will be measured as a relation between the number of people invited to enroll versus the number who enroll
NRT use
时间窗: 2 weeks post-discharge
Number of participants who use the NRT provided
Acceptability of smoking intervention
时间窗: 2 weeks post-discharge
Self-report by participant via survey. Score ranges from 1-7, with 1 indicating would not recommend implementing cessation program and 7 indicating definitely recommend implementing program.
Enrollment in Study
时间窗: Study recruitment, approximately 6 months
Enrollment will be measured as a relation between the number of people invited to enroll versus the number who enroll
NRT Use
时间窗: 2 weeks post-discharge, up to 4 weeks
Number of participants who use the NRT provided
Acceptability of Smoking Intervention
时间窗: 2 weeks post-discharge, up to 4 weeks
Self-report by participant via survey. Score ranges from 1-7, with 1 indicating would not recommend implementing cessation program and 7 indicating definitely recommend implementing program.
次要结局
- Change in number of cigarettes smoked per day(Baseline to 2 weeks post-discharge)
- Number of times participant left child's bedside to smoke(From admission to discharge, up to 4 weeks)
- Change in self-confidence in quitting smoking(Baseline to 2 weeks post-discharge)
- Change in motivation to quit smoking(Baseline to 2 weeks post-discharge)
- Change in Number of Cigarettes Smoked Per Day(Baseline to 2 weeks post-discharge, up to 4 weeks)
- Change in Trips Outside(From admission to discharge, up to 4 weeks)
- Change in Self-confidence in Quitting Smoking(Baseline to 2 weeks post-discharge, up to 4 weeks)
- Change in Motivation to Quit Smoking(Baseline to 2 weeks post-discharge, up to 4 weeks)