Empowering Patients to Better Manage Diabetes Through Self-Care
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
The objective of this particular study is to determine if the addition of regular pharmacist visits to usual care can improve clinical outcomes in patients with diabetes. The central hypothesis is that a program overseen by community pharmacists that empowers patients to self-manage their diabetes will lead to improved clinical and humanistic outcomes and will be cost-effective. Strong preliminary data collected from other sites suggests that patient empowerment programs are effective at reducing hemoglobin A1C after 12 months and in reducing the total cost of care. This hypothesis will be tested by pursuing three specific aims to evaluate the impact of a pharmacist-administered diabetes patient empowerment program on:
- clinical markers for diabetes and related metabolic disorders;
- the cost of care and resource utilization; and
- patient knowledge and perceived ability to manage diabetes. There is an additional specific aim to assess the pharmacists with respect to satisfaction with the training program and the overall project, the activities conducted in patient sessions, and the time taken to complete the visits in this study.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- diabetes (Type I or Type II)
- enrolled in health plan with participating employer
- age 18 or older
- willing and able to provide informed consent
Exclusion Criteria:
- gestational diabetes
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Usual Care plus out-of-pocket cost waiver
Patients received educational materials (handouts) in the mail.
This was assumed to be of minimal effectiveness.
Patients also received waiver of out-of-pocket expenses for diabetes care.
|
Patients received educational materials (handouts) in the mail.
This was assumed to be of minimal effectiveness.
Patients also received waiver of out-of-pocket expenses for diabetes care.
|
|
Experimental: EMPOWER
Patients were scheduled for free counseling with pharmacists including medication, diet, and other self-management items.
Patients also received waiver of out-of-pocket expenses for diabetes care.
|
Patients were scheduled for free counseling with pharmacists including medication, diet, and other self-management items.
Patients also received waiver of out-of-pocket expenses for diabetes care.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Hemoglobin A-1C From Baseline
Periodo de tiempo: baseline and 12 months
|
Compare changes in Hemoglobin A-1C from baseline between the two groups.
|
baseline and 12 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Changes From Baseline in LDL, HDL, Total Cholesterol, Triglycerides
Periodo de tiempo: baseline and 12 months
|
Changes from baseline in LDL, HDL, total cholesterol, triglycerides. Sample sizes for each individual test (usual care plus out-of-pocket cost waiver; EMPOWER group):
|
baseline and 12 months
|
|
Changes in Economic Outcomes (Total Cost of Care, Cost of Diabetes Medications, Cost of Diabetes Supplies) From Baseline to 12 Months
Periodo de tiempo: baseline to 12 months
|
Changes in claims-based economic data on costs of total health care, diabetes medications, and diabetes supplies from baseline to 12 months. Only participants who had a claim in the 12 months prior to baseline were included in these analyses. The resulting sample sizes (usual care plus out-of-pocket cost waiver; EMPOWER group) for these outcomes are:
|
baseline to 12 months
|
|
Change in Diabetes Knowledge and Empowerment (Patient Self-efficacy) From Baseline to 12 Months
Periodo de tiempo: From baseline to 12 months
|
Psycho-social aspects of diabetes knowledge and empowerment. Sample sizes are in parentheses (usual care plus out-of-pocket cost waiver; EMPOWER group):
|
From baseline to 12 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Dale F Kraemer, Ph.D., Oregon State University, College of Pharmacy
Publicaciones y enlaces útiles
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 (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
- OSU_COP_PP_0105
- IRB Application 2979
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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Ensayos clínicos sobre Educational materials
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University of MichiganNational Heart, Lung, and Blood Institute (NHLBI)Terminado