- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00505960
Culturally Tailored Behavioral Diabetes Care Intervention for Korean Americans
Diabetes Care for Korean Americans
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Korean American immigrants (KAI), one of the most underserved and understudied minority populations in the U.S., suffer from diabetes, which goes under-diagnosed, inadequately treated and has a potential to result in costly and tragic consequences. Language barriers, the lack of self-confidence, and diminished social support that accompany the acculturation process prevent KAI from improving their health-seeking behaviors. Our previous research has indicated that overwhelming numbers of KAI suffer not only from uncontrolled hyperglycemia but also from a loss of self-confidence and social isolation because of language and cultural barriers. They are in urgent need of an intervention to assist them in their efforts to achieve better glycemic control and restore their self-confidence in diabetes and health management so that they are able to adjust successfully in this new environment. Therefore, The purpose of this study is to assess the feasibility and efficacy of a culturally-tailored, comprehensive behavioral intervention program specially designed for linguistically challenged KAIs with type 2 DM.
This pilot project will test the hypothesis: Compared to KAI in the control group, KAI with type 2 DM who receive a comprehensive DM management intervention through structured psycho-behavioral education, home glucose monitoring with a telephone transmission system, and interaction with a bilingual nurse case manager will show: (1) a greater level of glucose control; and (2) a greater level of self-help skills including knowledge related to glucose control, problem-solving skills, heightened confidence and mood/affect, adherence to treatment recommendations, and quality of life. An additional outcome will be to measure and obtain an ideal BP as the proposed intervention focuses on management of multiple risk factors with which many KA DM patients often struggle.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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-
Maryland
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Ellicott City, Maryland, Estados Unidos, 20143
- Korean Resource Center
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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:
- Self-identified as a first generation Korean American
- Age 30 years or older
- Resides in Washington-Baltimore area
- Expresses willingness to participate in all aspects of the study over its full course
- Written consent to participate in the screening/eligibility visit
- Self-identified with DM and HbA1c >= 8% within 6 months of screening
- Written consent to participate in the clinical trial: agreeing to participate in study data collection procedures, receiving DM self -help education, using HGMT, and permitting contact with their own medical care provider.
Exclusion Criteria:
- Unable to give informed consent
- Physical or mental health conditions that could limit active participation in the study (e.g., blindness in both eyes, severe immobility, psychiatric diseases)
- Hematological condition that would affect A1C assay, e.g., hemolytic anemia, sickle cell anemia.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 1
|
Intervention group participants receive a 6-week in-class education offered by trained nurses, followed by home glucose monitoring with monthly nurse telephone counseling.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
HbA1c
Periodo de tiempo: 30 Weeks
|
The primary outcome varialbe is hemoglobin A1c level of the study participants to assess the status of blood gluocse management and control during previous 2-3 months.
|
30 Weeks
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
BP control
Periodo de tiempo: 30 weeks
|
30 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Miyong T Kim, PhD, Johns Hopkins University School of Nursing
Publicaciones y enlaces útiles
Publicaciones Generales
- Song HJ, Han HR, Lee JE, Kim J, Kim KB, Nguyen T, Kim MT. Translating current dietary guidelines into a culturally tailored nutrition education program for Korean American immigrants with type 2 diabetes. Diabetes Educ. 2010 Sep-Oct;36(5):752-61. doi: 10.1177/0145721710376328. Epub 2010 Jul 22.
- Kim MT, Han HR, Song HJ, Lee JE, Kim J, Ryu JP, Kim KB. A community-based, culturally tailored behavioral intervention for Korean Americans with type 2 diabetes. Diabetes Educ. 2009 Nov-Dec;35(6):986-94. doi: 10.1177/0145721709345774.
- Nam S, Han HR, Song HJ, Song Y, Kim KB, Kim MT. Utility of a point-of-care device in recruiting ethnic minorities for diabetes research with community partners. J Health Care Poor Underserved. 2011 Nov;22(4):1253-63. doi: 10.1353/hpu.2011.0117.
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R34DK071957 (Subvención/contrato del NIH de EE. UU.)
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