- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Glostrup, Dänemark, 2600
- Research Center for Prevention and Health
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
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. |
Smoking cessation program developed in cooperation with and aimed at smokers with low education.
Andere Namen:
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Kein Eingriff: Control
No smoking cessation program.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Smoking rate in hospitals randomised to intervention or control group
Zeitfenster: 12 months
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Self-reported point abstinence
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12 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Smoking cessation rate in persons participating in the group-based intervention
Zeitfenster: 6 months
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Self-reported point abstinence + carbonmonoxide validated abstinence
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6 months
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Smoking cessation rate in persons participating in the intervention
Zeitfenster: 6 weeks after fixed quit date
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Carbonmonoxide validated abstinence
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6 weeks after fixed quit date
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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Charlotta Pisinger, MD PhD MPH, Research Center for Prevention and Health
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- F-51061
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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