Community Health Workers in Diabetes Care in American Samoa (DCAS)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Brown University
The Miriam Hospital
Tafuna Family Health Center
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00850824
First received: February 23, 2009
Last updated: March 1, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus
Behavioral: Community Health Worker home visits

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Diabetes Care in American Samoa

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • glycosolated hemoglobin (HbA1c) levels [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood pressure [ Time Frame: one year ] [ Designated as safety issue: No ]
  • serum lipid levels [ Time Frame: one year ] [ Designated as safety issue: No ]
  • abdominal circumference [ Time Frame: one year ] [ Designated as safety issue: No ]
  • changes in exericse patterns [ Time Frame: one year ] [ Designated as safety issue: No ]
  • changes in dietary intake [ Time Frame: one year ] [ Designated as safety issue: No ]
  • keeping scheduled medical appointments [ Time Frame: one year ] [ Designated as safety issue: No ]
  • keeping specialty referral for medical exams [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 365
Study Start Date: October 2007
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Behavioral
Community Health Worker home visits
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.
Active Comparator: Usual Care
Usual Care, Wait List Control
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.

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.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00850824

Locations
American Samoa
Tafuna Family Health Center
Pago Pago, American Samoa, 96799
Sponsors and Collaborators
Brown University
The Miriam Hospital
Tafuna Family Health Center
Investigators
Principal Investigator: Stephen T McGarvey, PhD, MPH Brown University, Providence, RI, USA
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stephen T McGarvey, Professor of Community Health, Principal Investigator, Brown University
ClinicalTrials.gov Identifier: NCT00850824     History of Changes
Other Study ID Numbers: R18 DK075371-DCAS, NIH Grant R18-DK075371
Study First Received: February 23, 2009
Last Updated: March 1, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
T2DM

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 16, 2014