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

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Targeted smoking cessation

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.

• Study Type: Interventional
• Enrollment (Actual): 7003
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Glostrup, Denmark, 2600
    • Research Center for Prevention and Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Targeted smoking cessation; Smoking cessation program developed in cooperation with and aimed at smokers with low education.; Other Names: Smoking cessation - tailored to smokers with low education
No Intervention: Control; No smoking cessation program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking rate in hospitals randomised to intervention or control group	Self-reported point abstinence	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking cessation rate in persons participating in the group-based intervention	Self-reported point abstinence + carbonmonoxide validated abstinence	6 months
Smoking cessation rate in persons participating in the intervention	Carbonmonoxide validated abstinence	6 weeks after fixed quit date

Collaborators and Investigators

• Sponsor: Glostrup University Hospital, Copenhagen
• Collaborators: University of Aarhus; Rygestopkonsulenterne, Hillerød
• Investigators: Principal Investigator: Charlotta Pisinger, MD PhD MPH, Research Center for Prevention and Health

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: February 22, 2016
• First Submitted That Met QC Criteria: March 2, 2016
• First Posted (Estimate): March 8, 2016

Study Record Updates

• Last Update Posted (Estimate): March 15, 2016
• Last Update Submitted That Met QC Criteria: March 14, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: F-51061

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Will be stored in safe database at Research Center for Prevention and Health