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

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ClinicalTrials.gov Identifier: NCT02701530
Recruitment Status : Completed
First Posted : March 8, 2016
Last Update Posted : March 15, 2016
Sponsor:
Collaborators:
Rygestopkonsulenterne, Hillerød
Institut for Uddannelse og Pædagogik, Aarhus University
Information provided by (Responsible Party):
Charlotta Pisinger, Glostrup University Hospital, Copenhagen

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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Targeted smoking cessation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7003 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Smoking Cessation for Hospital Employees With Low Education in the Capital Region of Denmark. The RESPEKT Study.
Study Start Date : August 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


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 Name: Smoking cessation - tailored to smokers with low education

No Intervention: Control
No smoking cessation program.



Primary Outcome Measures :
  1. Smoking rate in hospitals randomised to intervention or control group [ Time Frame: 12 months ]
    Self-reported point abstinence


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02701530


Locations
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Denmark
Research Center for Prevention and Health
Glostrup, Denmark, 2600
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Rygestopkonsulenterne, Hillerød
Institut for Uddannelse og Pædagogik, Aarhus University
Investigators
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Principal Investigator: Charlotta Pisinger, MD PhD MPH Research Center for Prevention and Health

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Responsible Party: Charlotta Pisinger, Consultant Senior researcher Ass Prof, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT02701530     History of Changes
Other Study ID Numbers: F-51061
First Posted: March 8, 2016    Key Record Dates
Last Update Posted: March 15, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Will be stored in safe database at Research Center for Prevention and Health