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Culturally Tailored Behavioral Diabetes Care Intervention for Korean Americans
Diabetes Care for Korean Americans
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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Maryland
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Ellicott City, Maryland, Verenigde Staten, 20143
- Korean Resource Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 1
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Intervention group participants receive a 6-week in-class education offered by trained nurses, followed by home glucose monitoring with monthly nurse telephone counseling.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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HbA1c
Tijdsspanne: 30 Weeks
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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.
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30 Weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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BP control
Tijdsspanne: 30 weeks
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30 weeks
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Miyong T Kim, PhD, Johns Hopkins University School of Nursing
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- R34DK071957 (Subsidie/contract van de Amerikaanse NIH)
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