Smoking Cessation for Hospital Employees With Low Education.

NCT ID: NCT02701530

Last Updated: 2016-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7003 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2016-02-29

Brief Summary

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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

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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.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Targeted smoking cessation

Intervention Type BEHAVIORAL

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

Control

No smoking cessation program.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Targeted smoking cessation

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Smoking cessation - tailored to smokers with low education

Eligibility Criteria

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Inclusion Criteria

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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rygestopkonsulenterne, Hillerød

UNKNOWN

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role collaborator

Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Charlotta Pisinger

Consultant Senior researcher Ass Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Charlotta Pisinger, MD PhD MPH

Role: PRINCIPAL_INVESTIGATOR

Research Center for Prevention and Health

Locations

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Research Center for Prevention and Health

Glostrup Municipality, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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F-51061

Identifier Type: -

Identifier Source: org_study_id

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