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Randomized Controlled Trial (RCT) of a Motivational Decision Support System (RCTEDSS)

2018年11月3日 更新者:Mary F. Brunette, MD、Dartmouth-Hitchcock Medical Center

RCT of a Motivational Decision Support System for Smokers With Severe Mental Illnesses

In this study we will definitively test the decision support system in a randomized controlled trial (RCT) among smokers with severe mental illness (SMI) psychotic disorders. The Specific Aims of the study are:

  1. To determine whether use of the web-based decision support system leads to higher rates of initiation of smoking cessation treatment than use of a computerized educational pamphlet. We will also assess effectiveness on secondary outcomes, including smoking behavior, urges and outcome expectancies; level of dependence; intentions to quit and to use cessation treatment; and abstinence.
  2. To assess whether cognitive ability moderates initiation of smoking cessation treatment. Since cognitive impairment impedes use of standard web-based interventions by this group, and cognitive impairments likely supersede other potential moderators (education and socioeconomic status), this aim will be key to determining the success of our intervention and will guide further revisions if they are needed.
  3. To explore the effects of the decision support system and baseline cognitive ability on abstinence over 6 months

    1. We will examine the impact of the DSS on 7-day point prevalence tobacco abstinence at 6 months, and cumulative days of tobacco abstinence over 6 months.
    2. We will determine whether baseline cognition (scale scores) is associated with 7-day point prevalence tobacco abstinence at 6 months, and cumulative days of tobacco abstinence over 6 months.

研究概览

详细说明

Up to 80% of people with schizophrenia and schizoaffective disorders smoke - a rate that is four times the rate in the general population. Cessation treatments are effective, but these smokers don't use them. In order to provide an easy-to-use, cost-effective strategy to engage this group of smokers into effective treatments, we developed a single-session, web-based, motivational decision support system, Let's Talk About Smoking. The system incorporates features that insure high usability among those who can't use current websites due to cognitive impairments and low computer skills. It provides compelling content that engages users into evidence-based cessation treatments.

In this study we will definitively test the decision support system in a randomized controlled trial (RCT) among smokers with severe mental illness (SMI) psychotic disorders. Our proposed study design will enable us to test whether this system, designed for those with cognitive impairments, is effective among people with a range of cognitive abilities. The Specific Aims of the study are:

  1. To determine whether use of the web-based decision support system leads to higher rates of initiation of smoking cessation treatment than use of a computerized educational pamphlet. We will also assess effectiveness on secondary outcomes, including smoking behavior, urges and outcome expectancies; level of dependence; intentions to quit and to use cessation treatment; and abstinence.
  2. To assess whether cognitive ability moderates initiation of smoking cessation treatment. Since cognitive impairment impedes use of standard web-based interventions by this group, and cognitive impairments likely supersede other potential moderators (education and socioeconomic status), this aim will be key to determining the success of our intervention and will guide further revisions if they are needed.
  3. To explore the effects of the decision support system and baseline cognitive ability on abstinence over 6 months

    1. We will examine the impact of the DSS on 7-day point prevalence tobacco abstinence at 6 months, and cumulative days of tobacco abstinence over 6 months.
    2. We will determine whether baseline cognition (scale scores) is associated with 7-day point prevalence tobacco abstinence at 6 months, and cumulative days of tobacco abstinence over 6 months.

研究类型

介入性

注册 (实际的)

184

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Illinois
      • Chicago、Illinois、美国、60613
        • Thresholds
    • Massachusetts
      • Worcester、Massachusetts、美国、01605
        • University of Massachusetts
    • New Jersey
      • New Brunswick、New Jersey、美国、08901
        • Rutgers-UNDMJ

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 70年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 18-70 years old
  • DSM-IV-TR diagnosis psychotic disorder
  • in treatment at participating mental health center
  • current daily smoker
  • fluent in English
  • physically able to use computer
  • willing and able to give informed consent

Exclusion Criteria:

  • past 2 weeks use of evidence based cessation treatment
  • psychiatric instability
  • current alcohol or drug dependence
  • pregnant or nursing

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Behavioral intervention
Web-based motivational decision support system
有源比较器:Educational intervention
Computerized version of the National Cancer Institute (NCI) Educational Pamphlet

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Number of Subjects That Initiated Cessation Treatment
大体时间:6 months
Cessation treatment initiation and engagement will be collected from clinician attendance sheets in the medical record and medical record review for prescriptions. Medication use will be confirmed with self-report of taking medication.
6 months

次要结果测量

结果测量
措施说明
大体时间
Number of Subjects With Confirmed Abstinence
大体时间:6 months
Biologically confirmed abstinence: we will confirm 7-day point prevalence abstinence at 6 month assessments (self-reported abstinence without any smoking, "not even a puff," for the past 7 days,) with expired carbon monoxide (reading ≤9).
6 months
Number of Subjects With a Quit Attempt With 7 or More Days of Self-reported Abstinence
大体时间:6 months
6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Mary F. Burnette, MD、Dartmouth-Hitchcock Medical Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年4月1日

初级完成 (实际的)

2016年7月1日

研究完成 (实际的)

2016年7月1日

研究注册日期

首次提交

2014年3月11日

首先提交符合 QC 标准的

2014年3月11日

首次发布 (估计)

2014年3月13日

研究记录更新

最后更新发布 (实际的)

2018年11月29日

上次提交的符合 QC 标准的更新

2018年11月3日

最后验证

2018年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • FED14095
  • R01CA168778 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

De-identified research data files will be made available to all researchers in both the public and private sectors for potential statistical analyses or re-analyses in accordance with the NIH data Sharing Policy: http://grants.nih.gov/grants/policy/data sharing. Data will be available 2 years after data collection is completed, or after primary papers have been accepted for publication. Data will only be transferred to other researchers under a signed data sharing agreement.

Materials and research data files will be made available, upon request, from the PI. These requests can be made via email (mary.f.brunette@dartmouth.edu).

IPD 共享时间框架

Data will be available for sharing after we complete our analyses, estimated to be in January 2020.

IPD 共享访问标准

Investigators wishing to access data will submit a request with an analysis plan, data management plan and data safety plan to the PI. A signed data sharing agreement will be developed prior to release of the data.

IPD 共享支持信息类型

  • 研究方案

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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