- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00237094
Use of Midlevel Providers in Diabetes Management
Studies have demonstrated that intensive disease management of diabetes and its associated risk factors, hypertension and dyslipidemia, can prevent the progression of vascular complications. However, implementation of well defined guidelines for intensive disease management has been suboptimal. Barriers to success occur at multiple levels, including health care systems, health care providers and patients.
In rural regions of the U.S., reduced availability of primary care providers and specialty services, including diabetes education, present additional barriers to effective diabetes care. Use of a nurse practitioner led interdisciplinary team to intensively manage urban and rural diabetic patients, utilizing telehealth technology to provide care to rural areas, will help begin to address these barriers
The long term goal of the project is to develop a practical and sustainable system of intensive diabetes management that will be effective in helping diabetic patients achieve and maintain goals within established treatment guidelines regardless of geographic location.
Specific aims are:
- To determine in both urban and rural areas if a nurse practitioner led team approach to intensive diabetes management and education improves disease-specific outcomes and patient education compared to traditional care (current diabetes management of urban patients).
- To determine if telehealth is an effective and accepted mechanism for delivery of a nurse practitioner led team approach to intensive diabetes management and education in rural areas.
- To determine if a nurse practitioner led intensive disease management team can identify patient risk factors (psychological, financial, and work-related factors) that may be barriers to patient adherence, earlier in the management of urban diabetic patients compared to traditional care.
- To compare volume and type of service utilization of a nurse practitioner led team approach to diabetes management and education to that of traditional care in both urban and rural areas. Disease-specific outcomes will include physiologic variables (HbA1c, blood pressure, lipid levels), measurement and documentation of preventive services (dilated eye exam, monofilament exam, microabumin testing) and patient's knowledge of disease tested by questionnaire.
Results should show improved outcomes and patient knowledge in urban and rural patients receiving intensive disease management compared to traditional care.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Montana
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Billings, Montana, Estados Unidos, 59101
- Deaconess Billings Clinic Center on Aging
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Definitive diagnosis of Type II diabetes based on ADA diagnostic criteria.
- All persons with diabetes who do not meet ADA goals for glycemic, blood pressure or lipid control.This includes new or previously diagnosed patients.
- Men and women 21 years of age or older.
- Speaks and reads English
- Willing to participate (informed consent)
Exclusion Criteria:
- Type I diabetes
- Diagnosis of dementia or mental retardation.
- Resident of personal care home, assisted living, or long term care facility.
- Significant drug/alcohol abuse in the past 18 months.
- Active malignant process including patients on chemotherapy.
- Steroid induced diabetes or patient on chronic or intermittent steroid therapy (use for more than 2 months out of a year)
- Acute or chronic inflammatory or infectious disease process (chronic osteomyelitis, HIV, tuberculosis, bacterial endocarditis)
- End stage renal or liver disease.
- Pregnancy.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Colaboradores e Investigadores
Investigadores
- Investigador principal: Patricia J Coon, MD, Deaconess Billings Clinic
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
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
- 65787 (completed)
- 1R18DK065787-01A1 (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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