Northern Manhattan Diabetes Community Outreach Project

NCT ID: NCT00787475

Last Updated: 2015-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2014-02-28

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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

1

CHW intervention

Group Type: EXPERIMENTAL

Community Health worker

Intervention Type: OTHER

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

2

Enhanced usual care (brochure mailings)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Community Health worker

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

Intervention Type: OTHER

Eligibility 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 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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Walter Palmas, MD, MS, FAHA

Associate Professor of Clinical Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Walter Palmas, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University Medical Director

Locations

Columbia University Medical Center

New York, New York, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 24496805 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22454189 (View on PubMed)

Other Identifiers

MD00206P60

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

AAAD1689

Identifier Type: -

Identifier Source: org_study_id