Northern Manhattan Diabetes Community Outreach Project - Full Text View

Sponsors and Collaborators:	Columbia University National Institutes of Health (NIH)
Information provided by:	Columbia University
ClinicalTrials.gov Identifier:	NCT00787475

Purpose

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.

Condition	Intervention
Diabetes	Other: Community Health worker

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment
Official Title:	Northern Manhattan Diabetes Community Outreach Project

Further study details as provided by Columbia University:

Primary Outcome Measures:

Hg A1C [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

ldl [ Time Frame: 12 months ] [ Designated as safety issue: No ]
systolic blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	360
Study Start Date:	September 2008
Estimated Study Completion Date:	February 2014
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental CHW intervention	Other: Community Health worker Community Health workers with at least 4 home visits, 8 phone calls, and 10 group visits.
2: No Intervention enhanced usual care (brochure mailings)

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 3570 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.

Eligibility

Ages Eligible for Study:	35 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 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 CVD or diabetes intervention study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00787475

Contacts

Contact: Olveen Carrasquillo Carrasquillo, MD	212-305-9782	oc6@columbia.edu
Contact: Casandra Almonte	212-305-6299	ca2344@columbia.edu

Locations

United States, New York
Columbia University Medical Center	Recruiting
New York, New York, United States, 10032
Contact: Olveen Carrasquillo, MD 212-305-9782 oc6@columbia.edu
Contact: Casandra Almonte 212-305-6299 ca2344@columbia.edu
Principal Investigator: Olveen Carrasquillo, MD

Sponsors and Collaborators

Columbia University

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Olveen Carrasquillo, MD

Columbia University Medical Director

More Information

No publications provided

Responsible Party:	Columbia University Medical Center ( Dr. Olveen Carrasquillo/ Associate Professor of Medicine and Health Policy )
Study ID Numbers:	IRB-AAAD1689, Grant # MD00206 P60
Study First Received:	November 6, 2008
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00787475 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Columbia University:

diabetes, community health worker

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009