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Smoking Cessation for Hospital Employees With Low Education. (RESPEKT)

2016年3月14日 更新者:Charlotta Pisinger、Glostrup University Hospital, Copenhagen

Smoking Cessation for Hospital Employees With Low Education in the Capital Region of Denmark. The RESPEKT Study.

The aim of this trial is to develop a new tailored smoking cessation program for smokers with low education. Smokers are involved in design of the intervention. The effect of the intervention is then tested in a randomised controlled trial. Half of workplaces will be offered the intervention and the other half will be control group, not receiving any offer.

研究概览

地位

完全的

条件

详细说明

The target group of this trial is smokers with low education working in hospitals in the Capital Region of Denmark.

The aim is to develop a new tailored smoking cessation program for and together with smokers with low education. We selected following seven positions/occupations as proxy for low socioeconomic status: cleaner, porter, kitchen staff, social and health care assistant, service assistant, technical staff and medial secretary.

In first step the investigators perform focus group interviews with the target group to identify wishes and barriers. In next step the investigators design the new tailored smoking cessation program together with smokers with low education.

Then the investigators test the effect of the smoking cessation program in a randomised controlled trial. All hospitals in the Capital Region of Denmark except one are included (the last hospital is situated on a remote island). Half of the hospitals are randomised to be intervention group and the other half is control group. Recruitment will be by written invitations, posters and primarily by peer-recruitment (smokers with low education who are ambassadors for the project at the work places). Posters and written invitations show photos of the ambassadors in the target group and their statements; why they have decided to quit smoking.

The group-based smoking cessation intervention is designed with guidance from the anchor persons. There is no moralizing or disease-focusing, few written materials and a lot of drawings and humor. The intervention will be in small groups (4-6 persons), with six sessions (á 1½-2 hours) taking place at the workplace during working time. All counsellors are ex-smokers. Stress-management is included at each session. We offer free nicotine products or varenicline by choice, for up to 12 weeks. Nicotine replacement therapy is always based on the patch and combined with inhaler or mouth spray p.n. Nicotine gum is not offered.

The investigators measure validated abstinence rates at each session and 6 months after last session.

Main end-point is smoking rates after 12 months in intervention hospitals compared with smoking rates in control hospitals.

研究类型

介入性

注册 (实际的)

7003

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

      • Glostrup、丹麦、2600
        • Research Center for Prevention and Health

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

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria: employee with low education working in an intervention hospital in the Capital Region of Denmark.

We selected following seven positions/occupations as proxy for low socioeconomic status: cleaner, porter, kitchen staff, social and health care assistant, service assistant, technical staff and medial secretary.

-

Exclusion Criteria:

  • does not speak Danish

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:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Targeted smoking cessation

Smoking cessation program tailored in cooperation with the target group; smokers with low education.

Peer-based anti-relapse strategy. Recruitment strategy: peer-driven, written invitations and posters.

Smoking cessation program developed in cooperation with and aimed at smokers with low education.
其他名称:
  • Smoking cessation - tailored to smokers with low education
无干预:Control
No smoking cessation program.

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
Smoking rate in hospitals randomised to intervention or control group
大体时间:12 months
Self-reported point abstinence
12 months

次要结果测量

结果测量
措施说明
大体时间
Smoking cessation rate in persons participating in the group-based intervention
大体时间:6 months
Self-reported point abstinence + carbonmonoxide validated abstinence
6 months
Smoking cessation rate in persons participating in the intervention
大体时间:6 weeks after fixed quit date
Carbonmonoxide validated abstinence
6 weeks after fixed quit date

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:Charlotta Pisinger, MD PhD MPH、Research Center for Prevention and Health

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

2013年8月1日

初级完成 (实际的)

2015年8月1日

研究完成 (实际的)

2016年2月1日

研究注册日期

首次提交

2016年2月22日

首先提交符合 QC 标准的

2016年3月2日

首次发布 (估计)

2016年3月8日

研究记录更新

最后更新发布 (估计)

2016年3月15日

上次提交的符合 QC 标准的更新

2016年3月14日

最后验证

2016年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • F-51061

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

Will be stored in safe database at Research Center for Prevention and Health

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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