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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00833677
Other study ID # H2269-32042-02
Secondary ID 1R01NR010693-01
Status Completed
Phase N/A
First received January 29, 2009
Last updated October 29, 2013
Start date February 2009
Est. completion date March 2013

Study information

Verified date October 2013
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The proposed project is part of a program of research to improve management of type 2 diabetes (T2DM) through a community-academic partnership that addresses cultural factors in disease management. Specific aims are to: 1. Strengthen a community-academic partnership with the immigrant Chinese community in San Francisco to improve diabetes management; 2. Adapt and test a behavioral diabetes intervention, Coping Skills Training, to addresses family and cultural issues in immigrant Chinese patients with T2DM; and 3. Disseminate the adapted Coping Skills Training Program findings via the community-academic partnership to the immigrant Chinese American community through service programs, ethnic media, and professional/scientific publications. A mixed-methods CBPR approach will be used to interpretively adapt a behavioral intervention to be culturally appropriate, and test its efficacy using a repeated measures design. Two historically significant social service and health agencies serving immigrant Chinese in San Francisco are collaborating with this nurse-led interdisciplinary research team.


Description:

The goal of the culturally adapted Chinese Coping Skills Training (CCST) is to increase immigrant Chinese patients' skills and mastery in diabetes management by identifying and diminishing non-constructive coping responses to difficult social situations, while expanding the repertoire of positive coping responses and disease management behaviors. The CCST comprises a series of six small-group sessions focused on the topics of social problem solving, communication skills, cognitive behavior modification and conflict resolution. It also includes a review of basic diabetes management information.


Recruitment information / eligibility

Status Completed
Enrollment 148
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years and older
Eligibility Inclusion Criteria:

- Diagnosed with type 2 diabetes mellitus,

- Treated with insulin, oral medications and/or diet and exercise,

- Self-identify as Chinese American or Chinese,

- Identify a family member (spouse, child, sibling or other person identified as family) with whom participant lives or has at least weekly contact, who is involved in care of diabetes.

- First-generation immigrant ie. foreign-born, first generation to arrive in the U.S. from any source country

Exclusion Criteria:

- Diagnosed with type 1 diabetes mellitus

- Cannot read or write Chinese

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Intervention

Behavioral:
Chinese Coping Skills Training
Six-week group behavioral intervention: Chinese Coping Skills Training

Locations

Country Name City State
United States School of Nursing, University of California, San Francisco San Francisco California

Sponsors (5)

Lead Sponsor Collaborator
University of California, San Francisco Donaldina Cameron House, National Institute of Nursing Research (NINR), North East Medical Services, University of San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (4)

Chesla CA, Chun KM, Kwan CM. Cultural and family challenges to managing type 2 diabetes in immigrant Chinese Americans. Diabetes Care. 2009 Oct;32(10):1812-6. doi: 10.2337/dc09-0278. Epub 2009 Jul 23. — View Citation

Chesla CA, Chun KM. Accommodating type 2 diabetes in the Chinese American family. Qual Health Res. 2005 Feb;15(2):240-55. — View Citation

Chun KM, Chesla CA, Kwan CM. "So We Adapt Step by Step": Acculturation experiences affecting diabetes management and perceived health for Chinese American immigrants. Soc Sci Med. 2011 Jan;72(2):256-64. doi: 10.1016/j.socscimed.2010.11.010. Epub 2010 Nov 24. — View Citation

Fisher L, Chesla CA, Chun KM, Skaff MM, Mullan JT, Kanter RA, Gardiner PS. Patient-appraised couple emotion management and disease management among Chinese American patients with type 2 diabetes. J Fam Psychol. 2004 Jun;18(2):302-10. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Diabetes Self Efficacy 16 weeks post treatment-as compared with the delayed-treatment phase. No
Secondary Diabetes Specific Conflict 16 weeks post treatment as compared with the delayed treatment phase No
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