Community Health Workers in Diabetes Care in American Samoa

NCT00850824 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 268

Last updated 2015-10-07

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Community Health Worker home visits

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.

Sponsors & Collaborators

  • Brown University

    collaborator OTHER
  • The Miriam Hospital

    collaborator OTHER
  • Tafuna Family Health Center

    collaborator UNKNOWN
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Stephen T McGarvey, PhD, MPH · Brown University, Providence, RI, USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2011-06-30
Completion
2013-07-31

Countries

  • American Samoa

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00850824 on ClinicalTrials.gov