Northern Manhattan Diabetes Community Outreach Project (NOCHOP)

• ClinicalTrials.gov Identifier: NCT00787475
• Recruitment Status: Completed
• First Posted: November 7, 2008
• Last Update Posted: February 4, 2015
• Sponsor: Columbia University
• Collaborator: National Institutes of Health (NIH)
• Information provided by (Responsible Party): Walter Palmas, MD, MS, FAHA, Columbia University

Tracking Information

• First Submitted Date: November 6, 2008
• First Posted Date: November 7, 2008
• Last Update Posted Date: February 4, 2015
• Study Start Date: September 2008
• Actual Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 5, 2011): HgA1C level [ Time Frame: Up to 12 months ]
• Original Primary Outcome Measures (submitted: November 6, 2008): Hg A1C [ Time Frame: 12 months ]

Current Secondary Outcome Measures (submitted: October 5, 2011)

• Measurement of LDL [ Time Frame: Up to 12 months ]
• Measurement of systolic blood pressure [ Time Frame: Up to 12 months ]

Original Secondary Outcome Measures (submitted: November 6, 2008)

• ldl [ Time Frame: 12 months ]
• systolic blood pressure [ Time Frame: 12 months ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Northern Manhattan Diabetes Community Outreach Project
• Official Title: Northern Manhattan Diabetes Community Outreach Project

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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Prevention
• Condition: Diabetes

Intervention

Other: Community Health worker

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

Study Arms

• Experimental: 1
  CHW intervention
  Intervention: Other: Community Health worker
• No Intervention: 2
  Enhanced usual care (brochure mailings)

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 6, 2008): 360
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: February 2014
• Actual Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 35 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00787475
• Other Study ID Numbers: AAAD1689; MD00206P60 ( Other Grant/Funding Number: NIH )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Walter Palmas, MD, MS, FAHA, Columbia University
• Original Responsible Party: Dr. Olveen Carrasquillo/ Associate Professor of Medicine and Health Policy, Columbia University Medical Center
• Current Study Sponsor: Columbia University
• Original Study Sponsor: Same as current
• Collaborators: National Institutes of Health (NIH)

Investigators

• Principal Investigator: Walter Palmas, MD; Columbia University Medical Director

• PRS Account: Columbia University
• Verification Date: February 2015