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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
American Samoa
Study Type
Interventional
Intervention
Community Health Worker home visits
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring T2DM

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

-

Sites / Locations

  • Tafuna Family Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Behavioral

Usual Care

Arm Description

Community Health Worker home visits

Usual Care, Wait List Control

Outcomes

Primary Outcome Measures

glycosolated hemoglobin (HbA1c) levels

Secondary Outcome Measures

Blood pressure
serum lipid levels
abdominal circumference
changes in exericse patterns
changes in dietary intake
keeping scheduled medical appointments
keeping specialty referral for medical exams

Full Information

First Posted
February 23, 2009
Last Updated
October 5, 2015
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
Brown University, The Miriam Hospital, Tafuna Family Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT00850824
Brief Title
Community Health Workers in Diabetes Care in American Samoa
Acronym
DCAS
Official Title
Diabetes Care in American Samoa
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
Brown University, The Miriam Hospital, Tafuna Family Health Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
T2DM

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
268 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioral
Arm Type
Experimental
Arm Description
Community Health Worker home visits
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Usual Care, Wait List Control
Intervention Type
Behavioral
Intervention Name(s)
Community Health Worker home visits
Intervention Description
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 Outcome Measure Information:
Title
glycosolated hemoglobin (HbA1c) levels
Time Frame
one year
Secondary Outcome Measure Information:
Title
Blood pressure
Time Frame
one year
Title
serum lipid levels
Time Frame
one year
Title
abdominal circumference
Time Frame
one year
Title
changes in exericse patterns
Time Frame
one year
Title
changes in dietary intake
Time Frame
one year
Title
keeping scheduled medical appointments
Time Frame
one year
Title
keeping specialty referral for medical exams
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen T McGarvey, PhD, MPH
Organizational Affiliation
Brown University, Providence, RI, USA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tafuna Family Health Center
City
Pago Pago
ZIP/Postal Code
96799
Country
American Samoa

12. IPD Sharing Statement

Citations:
PubMed Identifier
18558029
Citation
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. Erratum In: Prev Chronic Dis. 2008 Oct;5(4):A138.
Results Reference
background
PubMed Identifier
19170313
Citation
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.
Results Reference
background
PubMed Identifier
20864729
Citation
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.
Results Reference
background
PubMed Identifier
21058808
Citation
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.
Results Reference
background
PubMed Identifier
23539136
Citation
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.
Results Reference
background
PubMed Identifier
23393217
Citation
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.
Results Reference
result
PubMed Identifier
24052204
Citation
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.
Results Reference
result
PubMed Identifier
24085749
Citation
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.
Results Reference
result
PubMed Identifier
30836964
Citation
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.
Results Reference
derived
PubMed Identifier
26491815
Citation
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.
Results Reference
derived

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Community Health Workers in Diabetes Care in American Samoa

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