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临床试验/NCT01412866
NCT01412866已完成不适用

Electronic Decision Support Systems for Smokers With Severe Mental Illness

Dartmouth-Hitchcock Medical Center1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2011年5月最近更新:
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
124
试验地点
1
主要终点
Initiation of Smoking Cessation Treatment

研究概览

简要总结

This randomized clinical trial among SMI smokers assessed whether the EDSS with carbon monoxide monitor and health-checklist feedback lead to higher rates of initiation of smoking cessation treatment, days of smoking abstinence and Fagerstrom Dependence scores, compared to use of the EDSS with checklist feedback alone.

详细描述

Up to 80% of Americans with serious mental illnesses (SMI; schizophrenia and severe mood disorders) smoke cigarettes, and most suffer related health consequences. Although combined treatment with medication and psychosocial therapy can help people with SMI to quit smoking, it is rarely used. Motivational interventions can enhance the use of combined treatment, but motivational interventions are expensive and unavailable. To fill this gap, Dartmouth and Thresholds investigators have developed an easy-to-use, web-based electronic decision support system (EDSS) that aims to educate and motivate smokers with SMI. Preliminary testing has demonstrated excellent usability and increased engagement in smoking cessation treatments.

One critical issue is the use of personalized health feedback. Motivational interventions for smoking cessation for smokers with SMI, including our EDSS, have included personal feedback from a breath monitor that measures carbon monoxide, a toxic component of cigarette smoke. Feedback regarding carbon monoxide is thought to motivate the user by personalizing the health risks of smoking. The carbon monoxide monitor is, however, expensive, difficult to implement, and largely unavailable in public mental health and primary care clinics. Further, research on use of carbon monoxide monitoring in the general population is equivocal. Another motivational strategy to personalize the negative health effects of smoking is a health checklist with feedback. Health checklists have been shown to be effective, are easy to use, have no expense, but have not been assessed separately from carbon monoxide monitor feedback among SMI smokers. Testing the effect of feedback from the health checklist compared to feedback from the carbon monoxide monitor is an essential next step in the development of this tool.

Aim 1. The investigators propose a randomized clinical trial among SMI smokers to assess whether the EDSS with carbon monoxide monitor and health-checklist feedback will lead to higher rates of initiation of smoking cessation treatment than the EDSS with health-checklist feedback alone.

Aim 1.a. To explore whether use of the EDSS with carbon monoxide monitor and health-checklist feedback leads to higher rates of the distal outcomes, days of smoking abstinence and Fagerstrom Dependence scores, than use of the EDSS with checklist feedback alone.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult age 18-75
  • in treatment for severe mental illness,
  • current smoker,
  • physically able to use a computer

排除标准

  • Using smoking cessation treatment in past month,
  • substance dependence with current use

研究组 & 干预措施

EDSS with CO monitor

Experimental

Web-based electronic decision support system (EDSS) with carbon monoxide (CO) monitor and health-checklist

干预措施: EDSS with CO feedback and health checklist (Behavioral)

EDSS without CO monitor

Active Comparator

Web-based electronic decision support system (EDSS) with health-checklist only

干预措施: EDSS with health checklist feedback alon (Behavioral)

结局指标

主要结局

Initiation of Smoking Cessation Treatment

时间窗: 2 months

Started smoking cessation treatment

次要结局

  • Days of Nicotine Abstinence(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mary F. Brunette, MD

MD

Dartmouth-Hitchcock Medical Center

研究点 (1)

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