Smoking CessationRESPEKTNCT02701530
Smoking Cessation for Hospital Employees With Low Education.
A study testing Targeted smoking cessation in people with Smoking Cessation, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Targeted smoking cessation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,003 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2013to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- does not speak Danish
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Research Center for Prevention and Health
Glostrup Municipality, 2600
About this study
Official title: 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.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- Targeted smoking cessation
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted smoking cessationBehavioural
Also called Smoking cessation - tailored to smokers with low education
Smoking cessation program developed in cooperation with and aimed at smokers with low education.
| Study group | Role | What they receive |
|---|---|---|
| Targeted smoking cessation | Experimental | 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. Receives: Behavioral: Targeted smoking cessation |
| Control | No intervention | No smoking cessation program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking rate in hospitals randomised to intervention or control group
Self-reported point abstinence
Measured: 12 months
Secondary outcomes (2)
Smoking cessation rate in persons participating in the group-based intervention
Self-reported point abstinence + carbonmonoxide validated abstinence
Measured: 6 months
Smoking cessation rate in persons participating in the intervention
Carbonmonoxide validated abstinence
Measured: 6 weeks after fixed quit date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startAug 2013
- Primary completionAug 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7,003 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Rygestopkonsulenterne, Hillerød, University of Aarhus
- Responsible party
- Principal investigator, Charlotta Pisinger, Glostrup University Hospital, Copenhagen
- Investigators
- Charlotta Pisinger, MD PhD MPH, Principal investigator, Research Center for Prevention and Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701530
- Sponsor's protocol ID
- F-51061
- Acronym
- RESPEKT
- Status last verified
- Mar 2016
- First submitted
- 22 Feb 2016
- Last updated
- 15 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Will be stored in safe database at Research Center for Prevention and Health
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation for Hospital Employees With Low Education in the Capital Region of Denmark. The RESPEKT Study.
- ClinicalTrials.gov ID
- NCT02701530
- Acronym / sponsor ID
- RESPEKT / F-51061
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,003 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Collaborators
- Rygestopkonsulenterne, Hillerød, University of Aarhus
- Study start
- Aug 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 8 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Targeted smoking cessation | Experimental | Behavioral: Targeted smoking cessationSmoking 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. |
| Control | No intervention | –No smoking cessation program. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- does not speak Danish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted smoking cessationAlso: Smoking cessation - tailored to smokers with low educationSmoking cessation program developed in cooperation with and aimed at smokers with low education. | Behavioural | Targeted smoking cessation |
Primary outcome
Smoking rate in hospitals randomised to intervention or control group
Time frame: 12 months
Self-reported point abstinence
2 secondary outcomes
Smoking cessation rate in persons participating in the group-based intervention
Time frame: 6 months
Smoking cessation rate in persons participating in the intervention
Time frame: 6 weeks after fixed quit date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2016.
- Individual participant dataSharing planned: Yes. Will be stored in safe database at Research Center for Prevention and Health
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotta Pisinger, MD PhD MPH principal investigator
Research Center for Prevention and Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted smoking cessation in people with Smoking Cessation, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking rate in hospitals randomised to intervention or control group (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2016.