- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00179374
Improving Diabetes Outcomes With Activity, Nutrition and Medication
Improving Diabetes Medication Adherence and Outcomes
This study has the following specific aims:
- A tailored telephone intervention will significantly improve medication adherence compared to a standard care intervention.
- A tailored telephone intervention will significantly improve metabolic control measured by HbA1c compared to a standard care intervention 2a) We will explore ways to link behavior change for medication adherence with lifestyle modification for diet and physical activity.
- To conduct cost evaluations for the telephone intervention vs. standard care.
Visão geral do estudo
Status
Condições
Descrição detalhada
Metabolic control of type 2 diabetes and prevention of its complications are related to management of blood glucose and other factors. Medication and lifestyle modifications are integral to most self-management plans; however, adherence remains a great challenge. Many patients have abnormal HbA1c, blood pressure and lipid values, and are at greater risk for complications. This study is to evaluate the effectiveness and costs of a tailored, telephone intervention to promote adherence in middle-aged and older adults with type-2 diabetes who are members of a union/employer-sponsored health benefit plan. The target population includes English- and Spanish-speaking individuals from the health plan database.
This study has the following specific aims:
- A tailored telephone intervention will significantly improve medication adherence compared to a standard care intervention.
- A tailored telephone intervention will significantly improve metabolic control measured by HbA1c compared to a standard care intervention 2a) We will explore ways to link behavior change for medication adherence with lifestyle modification for diet and physical activity.
- To conduct cost evaluations for the telephone intervention vs. standard care. The study design is a randomized, controlled intervention trial with masking; the individual is the unit of sampling, assignment and analysis. After eligibility is assessed and consent is obtained by telephone, patients will be randomized to either the telephone intervention or standard are. Study outcomes will be medication adherence as measured from pharmacy records and metabolic control (HbA1c). A total of 556 patients with type 2 diabetes wil be randomized, which will provide 80% power to detect a statistically significant difference in HbA1c of at least 0.3%, and over 95% power to detect a difference in filled prescriptions. Telephone surveys will provide data on self-care behaviors including diet and exercise, risk perceptions, and depressive symptoms. Cost data will be collected using standardized methods. Study results will inform implementation of practical, nurse-managed interventions to improve medication adherence and metabolic control in diverse, middle-aged and older, type 2 diabetes patients, while linking changes in medication adherence to lifestyle modification for diet and physical activity.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
New York
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Bronx, New York, Estados Unidos, 10461
- Albert Einstein College Of Medicine
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Type 2 diabetes
- Taking oral diabetes medication
- At least 40 years old
- In a union-sponsored health plan with full medication coverage for at least a year
- Able to understand English or Spanish
- Informed consent
Exclusion Criteria:
- Currently in a diabetes education program
- Will lose health care eligibility within a year
- Unable to receive phone calls or mail
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: 1
Tailored telephone intervention plus mailed print educational materials
|
Tailored telephone intervention to promote metabolic control of diabetes
|
Comparador Ativo: 2
print intervention with no telephone component
|
diabetes educational materials by mail
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Medication adherence
Prazo: 1 year
|
1 year
|
Metabolic control (measured by HbA1c)
Prazo: 1 year
|
1 year
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
Changes in self-care behaviors including diet and exercise
Prazo: 1 year
|
1 year
|
Cost evaluations
Prazo: 1 year
|
1 year
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Elizabeth A Walker, DNSc, RN, Albert Einstein College Of Medicine
- Investigador principal: Hillel W Cohen, DrPH, MPH, Albert Einstein College Of Medicine
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 (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
- 2003-068
- R18DK062038 (Concessão/Contrato do NIH dos EUA)
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