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| ID | Type | Description | Link |
|---|---|---|---|
| MD00206P60 | Other Grant/Funding Number | NIH |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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The objective of this study is to examine the effectiveness of a community health worker intervention at helping to control diabetes among Latinos with poorly controlled Type 2 diabetes.
Hypothesis: Compared to those in Enhanced usual care group, patients randomized to the intervention will, at 12 months, have greater reductions in: (1) HgA1C; (2) low density lipoprotein (LDL); and (3) systolic and diastolic BP.
The objective of this project is to examine the effectiveness of a community health worker (CHW) intervention at addressing glycemic control among Latinos with poorly controlled Type 2 diabetes. Our group has worked with a promising model of intervention that utilizes CHW's based at one of our major community partners. Pilot data from this program has shown clinically significant prepost test improvements in HgA1C. Using the Chronic Care Model as an overarching framework, the study design of NOCHOP is a randomized controlled trial of 360 Latinos, mostly of Caribbean descent, aged 35-70 years with HgA1C >=8.0. At a minimum, subjects in the intervention group will receive four home visits, ten group level visits and monthly phone calls by CHWs based at Alianza. The control groups will receive three separate mailings of bilingual diabetes health education materials. The primary outcome is glycemic control at 12month follow up, as measured by HgA1c. The secondary outcomes are changes in cholesterol and blood pressure (BP). We will also collect exploratory data on potential mechanisms through which our intervention resulted in hypothesized improvements including medication adherence, medication Intensification, diet and exercise. If successful, our project will make an important contribution to ongoing national and local debates about the sustainability of CHW programs. In particular, data from this study would be extremely useful for local Medicaid managed care plans who have expressed strong interests in data from rigorously designed clinical trials addressing the role of CHWs in delivering culturally appropriate and effective diabetes care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | CHW intervention |
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| 2 | No Intervention | Enhanced usual care (brochure mailings) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community Health worker | Other | Community Health workers with at least 4 home visits, 8 phone calls, and 10 group visits. |
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| Measure | Description | Time Frame |
|---|---|---|
| HgA1C level | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of LDL | Up to 12 months | |
| Measurement of systolic blood pressure | Up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Walter Palmas, MD | Columbia University Medical Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24496805 | Result | Palmas W, Findley SE, Mejia M, Batista M, Teresi J, Kong J, Silver S, Fleck EM, Luchsinger JA, Carrasquillo O. Results of the northern Manhattan diabetes community outreach project: a randomized trial studying a community health worker intervention to improve diabetes care in Hispanic adults. Diabetes Care. 2014 Apr;37(4):963-9. doi: 10.2337/dc13-2142. Epub 2014 Feb 4. | |
| 22454189 |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D003150 | Community Health Workers |
| ID | Term |
|---|---|
| D000488 | Allied Health Personnel |
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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| Palmas W, Teresi JA, Findley S, Mejia M, Batista M, Kong J, Silver S, Luchsinger JA, Carrasquillo O. Protocol for the Northern Manhattan Diabetes Community Outreach Project. A randomised trial of a community health worker intervention to improve diabetes care in Hispanic adults. BMJ Open. 2012 Mar 26;2(2):e001051. doi: 10.1136/bmjopen-2012-001051. Print 2012. |