Type 2 Diabetes MellitusNCT00833677
Community Based Participatory Research With Immigrant Chinese With Diabetes
A study testing Chinese Coping Skills Training in people with Type 2 Diabetes Mellitus, run by University of California, San Francisco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Chinese Coping Skills Training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Mar 2013
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Diagnosed with type 1 diabetes mellitus
- Cannot read or write Chinese
Trial locations and contacts
1 site in 1 country.
United States1 site
School of Nursing, University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Community Based Participatory Research With Immigrant Chinese With Type 2 Diabetes: Adapting and Testing Coping Skills Training.
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.
Read the detailed 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Chinese Coping Skills Training
- Keywords
- Coping skills, Chinese, Immigrant, Type 2 Diabetes Mellitus, Family research
- 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.
Chinese Coping Skills TrainingBehavioural
Six-week group behavioral intervention: Chinese Coping Skills Training
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes Self Efficacy
Measured: 16 weeks post treatment-as compared with the delayed-treatment phase.
Secondary outcomes (1)
Diabetes Specific Conflict
Measured: 16 weeks post treatment as compared with the delayed treatment phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), University of San Francisco, Donaldina Cameron House, North East Medical Services
- Responsible party
- Sponsor
- Investigators
- Catherine Chesla, DNS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00833677
- Sponsor's protocol ID
- H2269-32042-02
- Other IDs
- 1R01NR010693-01
- Status last verified
- Oct 2013
- First submitted
- 29 Jan 2009
- Last updated
- 31 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chesla CA, Chun KM. Accommodating type 2 diabetes in the Chinese American family. Qual Health Res. 2005 Feb;15(2):240-55. doi: 10.1177/1049732304272050.
PubMed 15611206Fisher 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. doi: 10.1037/0893-3200.18.2.302.
PubMed 15222837Chesla 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.
PubMed 19628812Chun 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.
PubMed 21147509
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Based Participatory Research With Immigrant Chinese With Type 2 Diabetes: Adapting and Testing Coping Skills Training.
- ClinicalTrials.gov ID
- NCT00833677
- Acronym / sponsor ID
- H2269-32042-02
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Coping skills, Chinese, Immigrant, Type 2 Diabetes Mellitus, Family research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), University of San Francisco, Donaldina Cameron House, North East Medical Services
- Study start
- Feb 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 2 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Diagnosed with type 1 diabetes mellitus
- Cannot read or write Chinese
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chinese Coping Skills TrainingSix-week group behavioral intervention: Chinese Coping Skills Training | Behavioural | – |
Primary outcome
Diabetes Self Efficacy
Time frame: 16 weeks post treatment-as compared with the delayed-treatment phase.
1 secondary outcome
Diabetes Specific Conflict
Time frame: 16 weeks post treatment as compared with the delayed treatment phase
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2013.
- Background: PubMed 15611206Chesla CA, Chun KM. Accommodating type 2 diabetes in the Chinese American family. Qual Health Res. 2005 Feb;15(2):240-55. doi: 10.1177/1049732304272050.
- Background: PubMed 15222837Fisher 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. doi: 10.1037/0893-3200.18.2.302.
- Background: PubMed 19628812Chesla 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.
- Background: PubMed 21147509Chun 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Chesla, DNS principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chinese Coping Skills Training in people with Type 2 Diabetes Mellitus, run by University of California, San Francisco 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 5 inclusion and 2 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 31 Oct 2013. 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?
Diabetes Self Efficacy (time frame: 16 weeks post treatment-as compared with the delayed-treatment phase.). 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 NCT00833677, 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 31 Oct 2013.