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临床试验/NCT00449852
NCT00449852已完成不适用

An Interactive, Voice Response-Mediated, Follow-up and Triage System for Smoking Cessation in Smokers With Coronary Heart Disease

Ottawa Heart Institute Research Corporation2 个研究点 分布在 1 个国家目标入组 440 人开始时间: 2006年7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
440
试验地点
2
主要终点
Biochemically confirmed 7-day point prevalent smoking abstinence

研究概览

简要总结

A randomized control trial is planned to evaluate an interactive voice response (IVR) mediated follow-up and triage system, against usual care, to help smokers hospitalized with Coronary Heart Disease (CHD) to quit smoking. The investigators hypothesize that compared to usual care, participants in the IVR group will; a) have a significantly higher 7-day point prevalence abstinence rate at 26 and 52 weeks after hospital discharge, b) will have a higher rate of continuous abstinence at 26 and 52 weeks after hospital discharge, c) will use a greater number of proven effective interventions over time, and d) will develop greater self-efficacy with respect to smoking cessation, over time.

详细描述

Quitting smoking appears to be the single most effective intervention or treatment to reduce mortality in patients with Coronary Heart Disease (CHD). However, despite interventions, almost two-thirds of smokers resumed smoking in the year after hospitalization for CHD related illnesses; one-third resumed smoking within one month. A critical challenge for institution-level programs is how to provide consistent patient follow-up and linkage to community-based smoking cessation resources. Interactive voice response (IVR) technology has the potential to improve follow-up with smokers after hospitalization and to enhance triage to clinical support for smoking cessation. IVR uses natural language to place automated out-going calls that can pose questions regarding smoking status and progress with smoking cessation, that is then dropped into a database. A counselor is then able to link with the database and obtain information about the patient's smoking cessation needs and provide support as appropriate. A randomized control trial (RCT) is planned to evaluate whether an IVR system for follow-up and triage helps smokers hospitalized for CHD, quit smoking over 26- and 52-week follow-up periods. Participants are randomized into either a Usual Care or IVR group. Both groups will receive in-patient counseling and offer of nicotine replacement therapy. The IVR group will additionally receive a telephone call from the IVR system three, 14, 30, 60, 90, 120, and 150 days after hospital discharge. Variables that will be assessed at 26 and 52 weeks include: smoking status, both 7-day point-prevalent and continuous abstinence, as well as self-efficacy for smoking cessation, use of effective cessation resources and patient satisfaction (at 26 weeks).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Other
盲法
Single (Care Provider)

盲法说明

Research Assistants completing follow up for outcome data at weeks 26 and 52 were blinded to the treatment allocation.

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient is currently a smoker (greater than 5 cigarettes per day in the month preceding admission);
  • Patient is 18 years of age and older;
  • Patient is admitted to the in-patient cardiology service at the University of Ottawa Heart Institute (UOHI) for: a) Acute Coronary Syndrome (includes patients admitted for unstable angina or acute myocardial infarction), b) Elective Percutaneous Coronary Intervention (PCI), c) Coronary Artery Bypass Graft (CABG) or d) diagnostic catheterization procedures related to CHD;
  • Patient has received automatic referral for smoking cessation counseling;
  • Patient is willing to provide informed consent

排除标准

  • Patient is unable to read and understand English;
  • Patient lives more than 1.5 hours from UOHI;
  • Patient is returning to referring institution/hospital

研究组 & 干预措施

Interactive Voice Response Group

Experimental

干预措施: Interactive Voice Response (Behavioral)

Usual Care Group

No Intervention

结局指标

主要结局

Biochemically confirmed 7-day point prevalent smoking abstinence

时间窗: 52 weeks

Continuous Abstinence Rate

时间窗: Baseline to 26 weeks

Self-reported abstinence from any tobacco product during the time period.

次要结局

  • Use of smoking cessation resources(26 & 52 weeks)
  • Self-efficacy in regards to smoking cessation(26 & 52 weeks)
  • Patient Satisfaction of the IVR system(26 weeks)
  • Continuous Abstinence since hospitalization(52 weeks)
  • Continuous Abstinence Rate(27 to 52 weeks)
  • 7-day Point-prevalence Abstinence Rates(At weeks 26 and 52.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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