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Completed

NCT Number: NCT02701530

Smoking Cessation for Hospital Employees With Low Education.

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Center for Prevention and Health

Glostrup Municipality, 2600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Targeted smoking cessation

Behavioral

Smoking cessation program developed in cooperation with and aimed at smokers with low education.

Other names: Smoking cessation - tailored to smokers with low education

Primary outcomes

  1. Smoking rate in hospitals randomised to intervention or control group

    Time frame: 12 months

    Self-reported point abstinence

Secondary outcomes

  1. Smoking cessation rate in persons participating in the group-based intervention

    Time frame: 6 months

    Self-reported point abstinence + carbonmonoxide validated abstinence

  2. Smoking cessation rate in persons participating in the intervention

    Time frame: 6 weeks after fixed quit date

    Carbonmonoxide validated abstinence

Sponsors and collaborators

Lead sponsor

Glostrup University Hospital, Copenhagen

Other

Collaborators

  • Rygestopkonsulenterne, Hillerød
  • University of Aarhus

Registry information

Official study title

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

Acronym: RESPEKT

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Mar 8, 2016
Registry last updated
Mar 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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