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Completed

NCT Number: NCT00850824

Community Health Workers in Diabetes Care in American Samoa

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.

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Key information

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tafuna Family Health Center

Pago Pago, 96799, American Samoa

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Community Health Worker home visits

Behavioral

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.

Primary outcomes

  1. glycosolated hemoglobin (HbA1c) levels

    Time frame: one year

Secondary outcomes

  1. Blood pressure

    Time frame: one year

  2. serum lipid levels

    Time frame: one year

  3. abdominal circumference

    Time frame: one year

  4. changes in exericse patterns

    Time frame: one year

  5. changes in dietary intake

    Time frame: one year

  6. keeping scheduled medical appointments

    Time frame: one year

  7. keeping specialty referral for medical exams

    Time frame: one year

Sponsors and collaborators

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Nih

Collaborators

  • Brown University
  • Tafuna Family Health Center
  • The Miriam Hospital

Registry information

Official study title

Diabetes Care in American Samoa

Acronym: DCAS

Important dates

Study start
2007
Primary completion
2011
Study completion
2013
First posted
Feb 25, 2009
Registry last updated
Oct 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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