An Observational Study Evaluating Patient Satisfaction and Quality of Life Associated With Switching Insulin (SWING)
15 de março de 2010 atualizado por: Eli Lilly and Company
Resource Utilisation and Patient Satisfaction With SWitching INsulin (SWING)
The purpose of this study is to estimate the direct costs associated with switching, in either direction, between a rapid-acting analog therapy and short-acting human insulin therapy within the first year following the switch.
The additional goals are: 1)to assess the impact of a switch from or to a rapid-acting analog insulin therapy on patient treatment satisfaction, 2) to assess the impact of a switch from or to a rapid-acting analog insulin therapy on patient quality of life, 3) to assess the impact of switch from or to the rapid-acting analog insulin therapy on the quality of metabolic control and, 4) to estimate the total costs (direct and indirect) associated with switching, in either direction between rapid-acting analog and short-acting human insulin within the first year following the switch.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Observacional
Inscrição (Real)
2459
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Bad Homburg, Alemanha, D-61350
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Bratislava, Eslováquia, 85101
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Athens, Grécia, 11527
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Bekescsaba, Hungria, 5600
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Budapest, Hungria, H-1139
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Dombovar, Hungria, 7200
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Dunaujvaros, Hungria, 2400
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Eger, Hungria, 3300
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Esztergom, Hungria, 2500
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Gyula, Hungria, 5700
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Hodmezovasarhely, Hungria, H-6800
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Kaposvar, Hungria, 7400
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Karcag, Hungria, 5301
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Kecskemet, Hungria, 6000
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Kisber, Hungria
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Mako, Hungria, 6900
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Mosonmagyarovar, Hungria, 9200
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Nagykanizsa, Hungria, 8800
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Oroshaza, Hungria, 5901
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Papa, Hungria, 8500
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Pecs, Hungria, 7623
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Szekszard, Hungria, 7100
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Konya, Peru, 42075
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Olesnica, Polônia
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Beroun, República Checa, 26601
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Bucharest, Romênia, 020045
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Purkersdorf, Áustria, 3002
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
Patients with Type II Diabetes treated with a regimen which includes any rapid-acting analog insulin or any short-acting human insulin
Descrição
Inclusion Criteria:
- are at least 18 years of age
- according to the clinical judgement of the investigator have been diagnosed with type II diabetes
- have presented within the normal course of care
- at the baseline visit are being treated with any therapy including a rapid-acting analog insulin component or any therapy including a short-acting human insulin component and are switching from one form of therapy to the other
- are not simultaneously participating in a study that includes an investigational drug or procedure at entry into the study
- have been fully informed and have given their written consent for the use of their data
- have a sufficient understanding of the primary language of the country such that they will be able to complete the questionnaires
Exclusion Criteria:
- no specific exclusion criteria exist for this study
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
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Rapid acting to short acting
Patients on rapid-acting analog insulins who switch to short-acting human insulin
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prescribed in accordance with usual clinical practice
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Short acting to rapid acting
Patients on short-acting human insulins who switch to rapid-acting analog insulin
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prescribed in accordance with usual clinical practice
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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The estimation of the direct costs associated with switching, in either direction, between a rapid-acting analog therapy and a short-acting human insulin therapy within the first year following the switch.
Prazo: 1 year
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1 year
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Medidas de resultados secundários
Medida de resultado |
Prazo |
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Change in Euro Quality of Life (EQ-5D)
Prazo: 1 year
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1 year
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Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Prazo: 1 year
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1 year
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Change in Diabetes Health Profile (DHP-18)
Prazo: 1 year
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1 year
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The estimation of the total costs (direct and indirect) associated with switching, in either direction, between rapid-acting analog and short-acting human insulin within the first year following the switch
Prazo: 1 year
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1 year
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de setembro de 2007
Conclusão Primária (Real)
1 de fevereiro de 2010
Conclusão do estudo (Real)
1 de fevereiro de 2010
Datas de inscrição no estudo
Enviado pela primeira vez
23 de outubro de 2007
Enviado pela primeira vez que atendeu aos critérios de CQ
23 de outubro de 2007
Primeira postagem (Estimativa)
26 de outubro de 2007
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
16 de março de 2010
Última atualização enviada que atendeu aos critérios de controle de qualidade
15 de março de 2010
Última verificação
1 de março de 2010
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 11760
- F3Z-EW-B003 (Outro identificador: Eli Lilly)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .