- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02701530
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Glostrup, Danmark, 2600
- Research Center for Prevention and Health
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
Smoking cessation program developed in cooperation with and aimed at smokers with low education.
Andre navn:
|
|
Ingen inngripen: Control
No smoking cessation program.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Smoking rate in hospitals randomised to intervention or control group
Tidsramme: 12 months
|
Self-reported point abstinence
|
12 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Smoking cessation rate in persons participating in the group-based intervention
Tidsramme: 6 months
|
Self-reported point abstinence + carbonmonoxide validated abstinence
|
6 months
|
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Smoking cessation rate in persons participating in the intervention
Tidsramme: 6 weeks after fixed quit date
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Carbonmonoxide validated abstinence
|
6 weeks after fixed quit date
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Charlotta Pisinger, MD PhD MPH, Research Center for Prevention and Health
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- F-51061
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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