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临床试验/NCT02701530
NCT02701530已完成不适用

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

Glostrup University Hospital, Copenhagen2 个研究点 分布在 1 个国家目标入组 7,003 人开始时间: 2013年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
7,003
试验地点
2
主要终点
Smoking rate in hospitals randomised to intervention or control group

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • does not speak Danish

结局指标

主要结局

Smoking rate in hospitals randomised to intervention or control group

时间窗: 12 months

Self-reported point abstinence

次要结局

  • Smoking cessation rate in persons participating in the intervention(6 weeks after fixed quit date)
  • Smoking cessation rate in persons participating in the group-based intervention(6 months)

研究者

发起方
Glostrup University Hospital, Copenhagen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Charlotta Pisinger

Consultant Senior researcher Ass Prof

Glostrup University Hospital, Copenhagen

研究点 (2)

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