Smoking Cessation Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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