Community Health Workers in Diabetes Care in American Samoa
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Community Health Worker home visits
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: T2DM