Community Health Workers in Diabetes Care in American Samoa

Study Overview
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Brief Summary
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As type 2 diabetes prevalence increases in the United States, the burden of diabetes falls more on groups with greater barriers to care, such as language and cultural differences, and lower economic resources. Healthy People 2010 targeted diabetes as one of six diseases for the elimination of racial and ethnic health disparities. These disparities extend to the US Territory of American Samoa, where the proportion of adults >18 years with diabetes was 19.6% in 2002, compared to 6.4% of US adults. There have been no reported diabetes interventions in Samoans in the US. The overall purpose of this application is to translate recent advances in diabetes care into clinical practice for the American Samoan community by improving methods of health care delivery and methods of diabetes self management. We will conduct a randomized clinical trial to test the effectiveness of a community health worker (CHW) and primary-care coordinated intervention to provide outreach, education and support to 352 type 2 diabetes patients and their families in American Samoa. The CHW intervention will utilize evidence-based algorithms and protocols to prompt risk behavior interventions, communication with health care team, and visit schedule. The individual treatment action plans are also guided by the Precede-Proceed Model. The outcomes at a one-year follow-up will include glycosolated hemoglobin (HbA1c), cardiovascular disease risk factors, diet and exercise behaviors, and adherence to diabetes care guidelines. The study hypothesis is that diabetes patients in the CHW trial arm will have lower HbA1c levels, lower cardiovascular disease risk factor levels, increased exercise behaviors and healthy dietary intakes and greater adherence to diabetes care such as adherence to prescribed medications, keeping medical appointments for diabetes care and specialty referrals. The intervention builds upon best clinical practices for CHWs in diabetes care by translating effective strategies to American Samoans, while also extending prior CHW research, by using a model that is potentially replicable in other ethnic minority populations suffering the burden of diabetes.

Detailed Description
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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.

Official Title
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Diabetes Care in American Samoa

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Community Health Worker home visits


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral<br>Community Health Worker home visits | Behavioral: Community Health Worker home visits<br>* 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.<br>|
| Active Comparator: Usual Care<br>Usual Care, Wait List Control | Behavioral: Community Health Worker home visits<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glycosolated hemoglobin (HbA1c) levels |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | one year | 
| serum lipid levels |  | one year | 
| abdominal circumference |  | one year | 
| changes in exericse patterns |  | one year | 
| changes in dietary intake |  | one year | 
| keeping scheduled medical appointments |  | one year | 
| keeping specialty referral for medical exams |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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T2DM