- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
New York
-
Bronx, New York, Estados Unidos, 10461
- Albert Einstein College of Medicine
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: 1
Tailored telephone intervention plus mailed print educational materials
|
Tailored telephone intervention to promote metabolic control of diabetes
|
Comparador activo: 2
print intervention with no telephone component
|
diabetes educational materials by mail
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Medication adherence
Periodo de tiempo: 1 year
|
1 year
|
Metabolic control (measured by HbA1c)
Periodo de tiempo: 1 year
|
1 year
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Changes in self-care behaviors including diet and exercise
Periodo de tiempo: 1 year
|
1 year
|
Cost evaluations
Periodo de tiempo: 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2003-068
- R18DK062038 (Subvención/contrato del NIH de EE. UU.)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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