Community Health Workers in Diabetes Care in American Samoa

NCT00850824 | Completed DMC

• 3 other identifiers: R18 DK075371-DCASNIH Grant R18-DK075371R18DK075371
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

Brief 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

Type 2 Diabetes Mellitus

Keywords

T2DM

Outcome Measures

Primary Outcomes (1)

• glycosolated hemoglobin (HbA1c) levels

  one year

Secondary Outcomes (7)

• 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

Study Arms (2)

Behavioral

EXPERIMENTAL

Community Health Worker home visits

Behavioral: Community Health Worker home visits

Usual Care

ACTIVE COMPARATOR

Usual Care, Wait List Control

Behavioral: Community Health Worker home visits

Interventions

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.

Behavioral; Usual Care

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead
• Brown University: collaborator
• The Miriam Hospital: collaborator
• Tafuna Family Health Center: collaborator

Study Sites (1)

Tafuna Family Health Center

Pago Pago, 96799, American Samoa

Location

Related Publications (10)

• Elstad E, Tusiofo C, Rosen RK, McGarvey ST. Living with Ma'i Suka: individual, familial, cultural, and environmental stress among patients with type 2 diabetes mellitus and their caregivers in American Samoa. Prev Chronic Dis. 2008 Jul;5(3):A79. Epub 2008 Jun 15.

  PMID: 18558029 BACKGROUND

• Rosen RK, DePue J, McGarvey ST. Overweight and diabetes in American Samoa: the cultural translation of research into health care practice. Med Health R I. 2008 Dec;91(12):372-3, 376-7. No abstract available.

  PMID: 19170313 BACKGROUND

• DePue JD, Rosen RK, Batts-Turner M, Bereolos N, House M, Held RF, Nu'usolia O, Tuitele J, Goldstein MG, McGarvey ST. Cultural translation of interventions: diabetes care in American Samoa. Am J Public Health. 2010 Nov;100(11):2085-93. doi: 10.2105/AJPH.2009.170134. Epub 2010 Sep 23.

  PMID: 20864729 BACKGROUND

• Held RF, DePue J, Rosen R, Bereolos N, Nu'usolia O, Tuitele J, Goldstein M, House M, McGarvey S. Patient and health care provider views of depressive symptoms and diabetes in American Samoa. Cultur Divers Ethnic Minor Psychol. 2010 Oct;16(4):461-7. doi: 10.1037/a0020089.

  PMID: 21058808 BACKGROUND

• Stewart DW, Depue J, Rosen RK, Bereolos N, Goldstein MG, Tuitele J, Nu'usolia O, McGarvey ST. Medication-taking beliefs and diabetes in American Samoa: a qualitative inquiry. Transl Behav Med. 2013 Mar 1;3(1):30-38. doi: 10.1007/s13142-012-0114-y. Epub 2012 Feb 1.

  PMID: 23539136 BACKGROUND

• DePue JD, Dunsiger S, Seiden AD, Blume J, Rosen RK, Goldstein MG, Nu'usolia O, Tuitele J, McGarvey ST. Nurse-community health worker team improves diabetes care in American Samoa: results of a randomized controlled trial. Diabetes Care. 2013 Jul;36(7):1947-53. doi: 10.2337/dc12-1969. Epub 2013 Feb 7.

  PMID: 23393217 RESULT

• DePue JD, Rosen RK, Seiden A, Bereolos N, Chima ML, Goldstein MG, Nu'usolia O, Tuitele J, McGarvey ST. Implementation of a culturally tailored diabetes intervention with community health workers in American Samoa. Diabetes Educ. 2013 Nov-Dec;39(6):761-71. doi: 10.1177/0145721713504630. Epub 2013 Sep 19.

  PMID: 24052204 RESULT

• Hamid S, Dunsiger S, Seiden A, Nu'usolia O, Tuitele J, DePue JD, McGarvey ST. Impact of a diabetes control and management intervention on health care utilization in American Samoa. Chronic Illn. 2014 Jun;10(2):122-34. doi: 10.1177/1742395313502367. Epub 2013 Oct 1.

  PMID: 24085749 RESULT

• Huang SJ, Galarraga O, Smith KA, Fuimaono S, McGarvey ST. Cost-effectiveness analysis of a cluster-randomized, culturally tailored, community health worker home-visiting diabetes intervention versus standard care in American Samoa. Hum Resour Health. 2019 Mar 5;17(1):17. doi: 10.1186/s12960-019-0356-6.

  PMID: 30836964 DERIVED

• Rao M, DePue JD, Dunsiger S, Elsayed M, Nu'usolia O, McGarvey ST. Long-Term Impact of a Community Health Worker Intervention on Diabetes Control in American Samoa. Prev Chronic Dis. 2015 Oct 22;12:E180. doi: 10.5888/pcd12.150160.

  PMID: 26491815 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Stephen T McGarvey, PhD, MPH

  Brown University, Providence, RI, USA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Epidemiology and Anthropology

Study Record Dates

• First Submitted: February 23, 2009
• First Posted: February 25, 2009
• Study Start: October 1, 2007
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2013
• Last Updated: October 7, 2015

Record last verified: 2015-10

Locations

AM (1)