- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00850824
Community Health Workers in Diabetes Care in American Samoa (DCAS)
Diabetes Care in American Samoa
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
We will perform a clinical trial to test the effectiveness of a community health worker (CHW) and primary-care coordinated intervention to provide outreach, education and support to diabetes patients and their families. The outcomes at a one-year follow-up will include glycosolated hemoglobin (HbA1c), CVD risk factors, diet and exercise behaviors, and adherence to diabetes care guidelines. The intervention builds upon best practices to date with CHWs, by translating effective strategies to Samoans, an ethnic minority population with no prior intervention research, while also extending prior CHW research, by using a model that is potentially replicable anywhere that uses outreach strategies in the context of primary care. This application builds on the current more limited activities of CHWs at the Tafuna Family Health Center (TFHC), a primary care health center established in 1998, operated by the American Samoa Government Department of Health, and designated as a community health center by the U.S. Bureau of Primary Health Care in 2003.
We will conduct a randomized controlled trial to test the effectiveness of a CHW outreach intervention, compared to usual care (UC) in a wait-list control group. The specific aims are:
A.1. To improve control of diabetes: We hypothesize that the CHW outreach intervention group will have greater one-year reductions in glycosolated hemoglobin (HbA1c) levels compared to the UC group.
A.2. To improve cardiovascular risk factors: We hypothesize that the CHW outreach intervention group will have greater one-year reductions in systolic and diastolic blood pressure, BMI, and abdominal circumference compared to the UC Group.
A.3. To improve diet and physical activity behaviors: We hypothesize that the diabetes patients randomized to the CHW intervention will have a greater one-year increase in favorable dietary and physical activity behaviors associated with self-management of their diabetes compared to the UC group.
A.4. To improve adherence to processes of diabetes care. The CHW group will have a higher percent of diabetes patients with the following American Diabetes Association (ADA) standards of care: 1) at least two HBA1c tests in the last year (at least 3 months apart), 2) percent of patients with documentation of self-management goals in the past 12 months, 3) percent of patients with a dental exam in past year, 4) percent of patients with a dilated eye exam in the past year, 5) percent of patients with a documented foot exam in the past year. We hypothesize that the CHW intervention will outperform UC on these variables over one year.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Pago Pago, American Samoa, 96799
- Tafuna Family Health Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: diagnosis of type 2 diabetes, age 21 years and above, resident of American Samoa receiving primary care at Tafuna Family Health Center -
Exclusion Criteria: pregnancy, receiving kidney dialysis
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Behavioral
Community Health Worker home visits
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Community health workers will educate diabetes patients and families about need for regular medical care, taking medications, increasing exercise patterns, improving diet, keeping medical referral exams for specialty.
|
Active Comparator: Usual Care
Usual Care, Wait List Control
|
Community health workers will educate diabetes patients and families about need for regular medical care, taking medications, increasing exercise patterns, improving diet, keeping medical referral exams for specialty.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
glycosolated hemoglobin (HbA1c) levels
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood pressure
Time Frame: one year
|
one year
|
serum lipid levels
Time Frame: one year
|
one year
|
abdominal circumference
Time Frame: one year
|
one year
|
changes in exericse patterns
Time Frame: one year
|
one year
|
changes in dietary intake
Time Frame: one year
|
one year
|
keeping scheduled medical appointments
Time Frame: one year
|
one year
|
keeping specialty referral for medical exams
Time Frame: one year
|
one year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Stephen T McGarvey, PhD, MPH, Brown University, Providence, RI, USA
Publications and helpful links
General Publications
- Elstad E, Tusiofo C, Rosen RK, McGarvey ST. Living with Ma'i Suka: individual, familial, cultural, and environmental stress among patients with type 2 diabetes mellitus and their caregivers in American Samoa. Prev Chronic Dis. 2008 Jul;5(3):A79. Epub 2008 Jun 15. Erratum In: Prev Chronic Dis. 2008 Oct;5(4):A138.
- Rosen RK, DePue J, McGarvey ST. Overweight and diabetes in American Samoa: the cultural translation of research into health care practice. Med Health R I. 2008 Dec;91(12):372-3, 376-7. No abstract available.
- DePue JD, Rosen RK, Batts-Turner M, Bereolos N, House M, Held RF, Nu'usolia O, Tuitele J, Goldstein MG, McGarvey ST. Cultural translation of interventions: diabetes care in American Samoa. Am J Public Health. 2010 Nov;100(11):2085-93. doi: 10.2105/AJPH.2009.170134. Epub 2010 Sep 23.
- Held RF, DePue J, Rosen R, Bereolos N, Nu'usolia O, Tuitele J, Goldstein M, House M, McGarvey S. Patient and health care provider views of depressive symptoms and diabetes in American Samoa. Cultur Divers Ethnic Minor Psychol. 2010 Oct;16(4):461-7. doi: 10.1037/a0020089.
- Stewart DW, Depue J, Rosen RK, Bereolos N, Goldstein MG, Tuitele J, Nu'usolia O, McGarvey ST. Medication-taking beliefs and diabetes in American Samoa: a qualitative inquiry. Transl Behav Med. 2013 Mar 1;3(1):30-38. doi: 10.1007/s13142-012-0114-y. Epub 2012 Feb 1.
- DePue JD, Dunsiger S, Seiden AD, Blume J, Rosen RK, Goldstein MG, Nu'usolia O, Tuitele J, McGarvey ST. Nurse-community health worker team improves diabetes care in American Samoa: results of a randomized controlled trial. Diabetes Care. 2013 Jul;36(7):1947-53. doi: 10.2337/dc12-1969. Epub 2013 Feb 7.
- DePue JD, Rosen RK, Seiden A, Bereolos N, Chima ML, Goldstein MG, Nu'usolia O, Tuitele J, McGarvey ST. Implementation of a culturally tailored diabetes intervention with community health workers in American Samoa. Diabetes Educ. 2013 Nov-Dec;39(6):761-71. doi: 10.1177/0145721713504630. Epub 2013 Sep 19.
- Hamid S, Dunsiger S, Seiden A, Nu'usolia O, Tuitele J, DePue JD, McGarvey ST. Impact of a diabetes control and management intervention on health care utilization in American Samoa. Chronic Illn. 2014 Jun;10(2):122-34. doi: 10.1177/1742395313502367. Epub 2013 Oct 1.
- Huang SJ, Galarraga O, Smith KA, Fuimaono S, McGarvey ST. Cost-effectiveness analysis of a cluster-randomized, culturally tailored, community health worker home-visiting diabetes intervention versus standard care in American Samoa. Hum Resour Health. 2019 Mar 5;17(1):17. doi: 10.1186/s12960-019-0356-6.
- Rao M, DePue JD, Dunsiger S, Elsayed M, Nu'usolia O, McGarvey ST. Long-Term Impact of a Community Health Worker Intervention on Diabetes Control in American Samoa. Prev Chronic Dis. 2015 Oct 22;12:E180. doi: 10.5888/pcd12.150160.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R18 DK075371-DCAS
- NIH Grant R18-DK075371
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