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Northern Manhattan Diabetes Community Outreach Project (NOCHOP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00787475
Recruitment Status : Completed
First Posted : November 7, 2008
Last Update Posted : February 4, 2015
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Walter Palmas, MD, MS, FAHA, Columbia University

Tracking Information
First Submitted Date  ICMJE November 6, 2008
First Posted Date  ICMJE November 7, 2008
Last Update Posted Date February 4, 2015
Study Start Date  ICMJE September 2008
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2011)
HgA1C level [ Time Frame: Up to 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 6, 2008)
Hg A1C [ Time Frame: 12 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Northern Manhattan Diabetes Community Outreach Project
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Condition  ICMJE Diabetes
Intervention  ICMJE Other: Community Health worker
Community Health workers with at least 4 home visits, 8 phone calls, and 10 group visits.
Study Arms  ICMJE
  • Experimental: 1
    CHW intervention
    Intervention: Other: Community Health worker
  • No Intervention: 2
    Enhanced usual care (brochure mailings)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 6, 2008)
360
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00787475
Other Study ID Numbers  ICMJE AAAD1689
MD00206P60 ( Other Grant/Funding Number: NIH )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Walter Palmas, MD, MS, FAHA, Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Walter Palmas, MD Columbia University Medical Director
PRS Account Columbia University
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP