Smoking Cessation for Hospital Employees With Low Education.

Smoking Cessation Clinical Trial

— RESPEKT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02701530
• Other study ID #: F-51061
• Status: Completed
• Phase: N/A
• First received: February 22, 2016
• Last updated: March 14, 2016
• Start date: August 2013
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7003
• Est. completion date: February 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Exclusion Criteria:

• does not speak Danish

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Targeted smoking cessation
Smoking cessation program developed in cooperation with and aimed at smokers with low education.

Locations

Country	Name	City	State
Denmark	Research Center for Prevention and Health	Glostrup

Sponsors (3)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen	Institut for Uddannelse og Pædagogik, Aarhus University, Rygestopkonsulenterne, Hillerød

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking rate in hospitals randomised to intervention or control group	Self-reported point abstinence	12 months	No
Secondary	Smoking cessation rate in persons participating in the group-based intervention	Self-reported point abstinence + carbonmonoxide validated abstinence	6 months	No
Secondary	Smoking cessation rate in persons participating in the intervention	Carbonmonoxide validated abstinence	6 weeks after fixed quit date	No