- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01979107
Early Detection of and Intervention Towards Chronic Diseases Among Individuals Without Formal Education
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The study will be conducted at Vesterbro and Amager in Copenhagen, Denmark, and general practitioners with a medical practice in this area will be invited to enter the study. From the patient lists of the participating general practitioners all persons aged 45-64 years will be identified and baseline questionnaires will be mailed to these persons.
The questionnaire information will be entered electronically into the general practitioners electronic chart system using the Danish Quality Unit of General Practice (DAK-E) system. Thus, the questionnaire information will provide the general practitioners with information in the electronic form on health behavior, symptoms and socioeconomic information on all his patients in this age group that would not normally have access to in a systematic way.
Persons who answer the baseline questionnaire and who do not have any formal education will randomly be divided into two groups - one intervention group and one control group.
All persons allocated to the intervention group will receive a personal invitation to an appointed health check from their general practitioner. The health check at the general practitioner includes measurement of weight, height, hip and waist circumference, blood pressure, lung function, blood sugar, total cholesterol, and thyroidal status.
Participants with abnormal screens at the health check will, depending of the severity, either receive the offer of the referral to the municipality health center for a lifestyle change program and/or follow the procedures for diagnostics and treatment. For individuals with abnormal screens or health behavior amenable to intervention at the first health check an additional health check will be scheduled six months after the first health check.
Persons allocated to the control group will receive a baseline questionnaire and other than that follow normal procedure in general practice.
At 12 month follow-up questionnaires will be send out to all participants at the intervention group as well as the control group.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Copenhagen K
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Copenhagen, Copenhagen K, Dinamarca, 1353
- National Institute of Public Health - University of Southern Denmark
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Participants must be 45-64 years old with no formal education beyond secondary school
- Participants must live in Copenhagen
- Participants' general practitioner must be participating in the study
Exclusion Criteria:
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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 |
---|---|
Experimental: Proactive action by the general practitioner
Proactive action by the general practitioner inviting to preventive health check.
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Individuals allocated to the intervention group will receive a personal invitation to an appointed health check from their general practitioner. Three days before the appointment participants will be reminded by phone about the appointment. At the health check a follow-up consultation will be scheduled. At the follow-up consultation the results of the health check will be reviewed. All participants with abnormal screens at the health check will, depending of the severity, either receive the offer of a referral to the municipality health center for a lifestyle change program and/or follow the procedures for diagnostics and treatment. This will follow the usual medical standards in general practice. For individuals with abnormal screens or health behavior amenable to intervention at the first health check an additional health check will be scheduled six months after the first health check with a follow-up consultation for review of the results. |
Sem intervenção: Control group
The participants will be treated as usual by the general practitioner.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Change from baseline in smoking status at 12 months
Prazo: 12 months
|
Change in the participants' smoking status from baseline to 12 month follow-up.
Measured with self-reported questionnaires at baseline and at 12 months.
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12 months
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Detection of chronic disease in form of chronic obstructive pulmonary disease, cardiovascular diseases and diabetes
Prazo: 12 months
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Detection of chronic disease in form of chronic obstructive pulmonary disease, cardiovascular diseases and diabetes at 12 months.
Number of chronic diseases are obtained from the general practitioner and from a number of administrative registers.
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12 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Change from baseline in alcohol consumption at 12 months
Prazo: 12 months
|
Change in the participants' alcohol consumption from baseline to 12 month follow-up.
Measured with self-reported questionnaires at baseline and at 12 months.
|
12 months
|
Change from baseline in physical activity level at 12 months
Prazo: 12 months
|
Change in the participants' physical activity level from baseline to 12 month follow-up.
Measured with self-reported questionnaires at baseline and at 12 months.
|
12 months
|
Change from baseline in perceived stress level at 12 months
Prazo: 12 months
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Change in the participants' perceived stress level measured with perceived stress scale (10 items).
Measured with self-reported questionnaires at baseline and at 12 months.
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12 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Diretor de estudo: Morten Grønbæk, MD, PhD., Centre for Intervention Research in Health Promotion and Disease Prevention - University of Southern Denmark
Publicações e links úteis
Publicações Gerais
- Kamstrup-Larsen N, Broholm-Jorgensen M, Dalton SO, Larsen LB, Thomsen JL, Tolstrup JS. Why do general practitioners not refer patients to behaviour-change programmes after preventive health checks? A mixed-method study. BMC Fam Pract. 2019 Oct 11;20(1):135. doi: 10.1186/s12875-019-1028-2.
- Kamstrup-Larsen N, Dalton SO, Gronbaek M, Broholm-Jorgensen M, Thomsen JL, Larsen LB, Johansen C, Tolstrup J. The effectiveness of general practice-based health checks on health behaviour and incidence on non-communicable diseases in individuals with low socioeconomic position: a randomised controlled trial in Denmark. BMJ Open. 2019 Sep 18;9(9):e029180. doi: 10.1136/bmjopen-2019-029180.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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 (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 61110-2095
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