NCT00505960

Brief Summary

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 ethnic minority immigrant populations (Korean Americans) with type 2 DM.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for phase_1 diabetes

Timeline
Completed

Started Sep 2007

Typical duration for phase_1 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 25, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

December 21, 2010

Status Verified

December 1, 2010

Enrollment Period

1 year

First QC Date

July 20, 2007

Last Update Submit

December 20, 2010

Conditions

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    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

Secondary Outcomes (1)

  • BP control

    30 weeks

Study Arms (1)

1

EXPERIMENTAL
Behavioral: Diabetes Care for Korean Americans

Interventions

Intervention group participants receive a 6-week in-class education offered by trained nurses, followed by home glucose monitoring with monthly nurse telephone counseling.

1

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korean Resource Center

Ellicott City, Maryland, 20143, United States

Location

Related Publications (3)

  • 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.

    PMID: 20651099BACKGROUND
  • 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.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Miyong T Kim, PhD

    Johns Hopkins University School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 20, 2007

First Posted

July 25, 2007

Study Start

September 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

December 21, 2010

Record last verified: 2010-12

Locations