- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Glostrup, Dinamarca, 2600
- Research Center for Prevention and Health
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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.
Outros nomes:
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Sem intervenção: Control
No smoking cessation program.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Smoking rate in hospitals randomised to intervention or control group
Prazo: 12 months
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Self-reported point abstinence
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12 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Smoking cessation rate in persons participating in the group-based intervention
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Charlotta Pisinger, MD PhD MPH, Research Center for Prevention and Health
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- F-51061
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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