Northern Manhattan Diabetes Community Outreach Project

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Other: Community Health worker

• Registration Number: NCT00787475
• Lead Sponsor: Columbia University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-11-06
• Study First Submitted QC: 2008-11-06
• Study First Posted: 2008-11-07
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-02
• Last Update Posted: 2015-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• Adult patients age 35-70 years*
• Receiving care at our clinic (2 visits with a primary care provider in the previous year)
• Living in Northern Manhattan or Western Bronx (based on zip codes)
• Had a hemoglobin A1C-done within the past year, with the latest value being > or = 8.0

Exclusion Criteria

• Patients whose primary care physician (PCP) believes are not appropriate candidates for participation
• Type 1 diabetics (identified by PCP), as their care is quite distinct from that of Type II patients, and there are very few such patients in our clinic
• Patients with diabetes diagnosed when under age 25 ("new-onset" Type I diabetes) as such patients are extremely rare in our primary care clinics
• Patients who do not self-identify as Hispanic (Hispanics can be of any race e.g. white, black, mixed)
• Any life-threatening or extreme medical co-morbidity, such as an active cancer diagnosis, paraplegia, or end stage cardio-pulmonary disease
• Having a diabetes diagnosis for < 1 year, to ensure the stability of hemoglobin A1C values above 8.0
• Planning to move out of the neighborhood during the next year
• Planning to travel out of the neighborhood for more than three consecutive months
• Enrollment in any other cardiovascular disease (CVD) or diabetes intervention study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Community Health worker	CHW intervention

Primary Outcome Measures

Name	Time	Method
HgA1C level	Up to 12 months

Secondary Outcome Measures

Name	Time	Method
Measurement of LDL	Up to 12 months
Measurement of systolic blood pressure	Up to 12 months

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States