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Type 2 DiabetesNCT01264796

Community-Based Diabetes Care for Korean American Immigrants

A study testing culturally tailored diabetes education in people with Type 2 Diabetes, run by University of Texas at Austin at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary aims are to test the effectiveness of the self-help DM intervention (SHIP-DM), a comprehensive, culturally tailored DM management intervention, in improving glucose outcomes; To determine the effectiveness of the SHIP-DM in KAI with type 2 DM in improving self-care skills and psycho-behavioral outcomes… Read more about this study

Who is it for?
Ages 30 to 75 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
culturally tailored diabetes education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
1 siteUnited States
Study dates
Nov 2009to Aug 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Self-identified as a first generation Korean American
  • Type 2 diabetes
  • Age 30-75 years
  • Resides in Washington-Baltimore area
  • Self-identified with DM and HbA1c >= 7.0 % within 6 months of screening
  • Expresses willingness to participate in all aspects of the study over its full course

Who cannot join

  • 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
  • Past experience in diabetes group education

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johns Hopkins University

    Baltimore, Maryland, 21205

Other trials in United States

About this study

The primary aims are to test the effectiveness of the self-help DM intervention (SHIP-DM), a comprehensive, culturally tailored DM management intervention, in improving glucose outcomes; To determine the effectiveness of the SHIP-DM in KAI with type 2 DM in improving self-care skills and psycho-behavioral outcomes related to DM control, to develop tangible infrastructures for the dissemination of valid and effective education materials to a wider population of KAI with type 2 DM in the US (e.g., audio-visual education materials, web-based intervention materials, mobile telephone-based intervention materials) and to explore the feasibility and acceptability of each dissemination module, utilizing the delayed intervention group participants. The secondary aims are to obtain preliminary cost-effectiveness data related to the proposed intervention, including cost estimates for this type of DM intervention, and to establish a systematic, long-term dissemination plan, including documenting effective methodologies, to facilitate faster translation of research findings and products to direct consumers in non-research settings.

Read the detailed description

Inclusion Criteria

  1. Self-identified as a first generation Korean American
  2. Type 2 diabetes
  3. Age 30-75 years
  4. Resides in Washington-Baltimore area
  5. Self-identified with DM and HbA1c >= 7.0 % within 6 months of screening
  6. Expresses willingness to participate in all aspects of the study over its full course

Exclusion criteria

  1. Unable to give informed consent
  2. Physical or mental health conditions that could limit active participation in the study (e.g., blindness in both eyes, severe immobility, psychiatric diseases)
  3. Hematological condition that would affect A1C assay, e.g., hemolytic anemia, sickle cell anemia
  4. Past experience in diabetes group education
Conditions
Type 2 Diabetes
Being tested
culturally tailored diabetes education
Keywords
Korean American, type 2 diabetes, culturally tailored
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • culturally tailored diabetes educationBehavioural

    Also called lifestyle modification

    lifestyle modification group education

Study groups in NCT01264796
Study groupRoleWhat they receive
behavioral intervention, counselingExperimental2hr group education for 6 weeks
Receives: Behavioral: culturally tailored diabetes education
delyed interventionNo interventioncontrol group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1c

    HbA1c level change from baseline comparing with control group

    Measured: 12month

  2. Blood pressure

    BP change from baseline comparing with control group

    Measured: 12 month

  3. Lipid profile

    LDL level change from baseline comparing with control group

    Measured: 12 months

  4. quality of life

    quality of life score change from baseline comparing with control group

    Measured: 12month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2010 (estimated)
  2. Study startNov 2009
  3. Primary completionJul 2014
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01264796
Sponsor's protocol ID
1R18DK083936-01
Other IDs
1R18DK083936-01
Status last verified
Mar 2012
First submitted
20 Dec 2010
Last updated
8 Mar 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Kim MT, Kim KB, Ko J, Murry N, Xie B, Radhakrishnan K, Han HR. Health Literacy and Outcomes of a Community-Based Self-Help Intervention: A Case of Korean Americans With Type 2 Diabetes. Nurs Res. 2020 May/Jun;69(3):210-218. doi: 10.1097/NNR.0000000000000409.

    PubMed 31972848

  • Kim MT, Kim KB, Ko J, Murry N, Levine D, Lee JY. The Differential Role of Vitamin D in Type 2 Diabetes Management and Control in Minority Populations. J Immigr Minor Health. 2019 Dec;21(6):1266-1274. doi: 10.1007/s10903-019-00857-x.

    PubMed 30747313

  • Kim MT, Kim KB, Ko J, Jang Y, Levine D, Lee HB. Role of depression in diabetes management in an ethnic minority population: a case of Korean Americans with type 2 diabetes. BMJ Open Diabetes Res Care. 2017 Mar 24;5(1):e000337. doi: 10.1136/bmjdrc-2016-000337. eCollection 2017.

    PubMed 28405343

  • Kim MT, Kim KB, Huh B, Nguyen T, Han HR, Bone LR, Levine D. The Effect of a Community-Based Self-Help Intervention: Korean Americans With Type 2 Diabetes. Am J Prev Med. 2015 Nov;49(5):726-737. doi: 10.1016/j.amepre.2015.04.033. Epub 2015 Jul 14.

    PubMed 26184986

Questions about this trial

What is this clinical trial studying?

A study testing culturally tailored diabetes education in people with Type 2 Diabetes, run by University of Texas at Austin at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c (time frame: 12month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01264796, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2017.

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