Northern Manhattan Diabetes Community Outreach Project

Diabetes Clinical Trial

— NOCHOP  

Official title:

Northern Manhattan Diabetes Community Outreach Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00787475
• Other study ID #: AAAD1689
• Secondary ID: MD00206P60
• Status: Completed
• Phase: N/A
• First received: November 6, 2008
• Last updated: February 2, 2015
• Start date: September 2008
• Est. completion date: February 2014

Study information

• Verified date: February 2015
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes

Intervention

Other:
• Community Health worker
Community Health workers with at least 4 home visits, 8 phone calls, and 10 group visits.

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 imp — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HgA1C level		Up to 12 months	No
Secondary	Measurement of LDL		Up to 12 months	No
Secondary	Measurement of systolic blood pressure		Up to 12 months	No