Clinical trial NCT02701530: Smoking Cessation for Hospital Employees With Low Education.
Official title: Smoking Cessation for Hospital Employees With Low Education in the Capital Region of Denmark. The RESPEKT Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
Collaborators: name: Rygestopkonsulenterne, Hillerød
name: University of Aarhus
First posted: 2016-03-08
Enrollment: 7003
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

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Exclusion Criteria:

* does not speak Danish

Primary outcomes:
measure: Smoking rate in hospitals randomised to intervention or control group
timeFrame: 12 months
Secondary outcomes:
measure: Smoking cessation rate in persons participating in the group-based intervention
timeFrame: 6 months
measure: Smoking cessation rate in persons participating in the intervention
timeFrame: 6 weeks after fixed quit date
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Research Center for Prevention and Health
Study officials:
affiliation: Research Center for Prevention and Health
name: Charlotta Pisinger, MD PhD MPH
role: PRINCIPAL_INVESTIGATOR
References: