Bronx A1c: Bring it Down for Health

NCT00797888 | Completed

• 2 other identifiers: 2007-271R18DK078077
• Study Type: interventional
• Target: 941
• Locations: 1 country
• Sites: 1

Brief Summary

To address and reduce population-attributable risk due to elevated HbA1c, the New York City Department of Health and Mental Hygiene (DOHMH) developed an innovative HbA1c registry, which requires all major laboratories to report HbA1c results electronically. We propose to utilize this registry to conduct a randomized controlled trial addressing the following specific aims: 1) to evaluate the incremental effect of a tiered and tailored, patient-centered telephone intervention, in English and Spanish, on the mean HbA1c levels beyond that achieved with print materials mailed to patients and providers by the DOHMH registry intervention; 2) determine what patient demographic and psychosocial factors mediate the effect of the interventions; and 3) provide estimates of implementation costs of the tiered, tailored telephone intervention for comparison with the print intervention. The study outcome will be change in HbA1c values from the registry records from baseline to one-year post-randomization. A total of 941 individuals with diabetes will be needed to provide 83% power to detect a statistically significant difference (p\<0.05) between groups of at least 0.3% in absolute HbA1c. Intervention cost data will be evaluated for translation of findings and scalability. At study end, we will know the extent to which this intervention will improve metabolic control in a low-income, multi-ethnic sample who are part of the DOHMH HbA1c registry in the South Bronx, New York. These findings will inform public health policies and practices in New York City, as well as other urban areas throughout the nation.

Conditions

Type 2 Diabetes

Keywords

diabetes; behavioral intervention; HbA1c; health disparities

Outcome Measures

Primary Outcomes (1)

• HbA1c

  1 year

Secondary Outcomes (1)

• diabetes self-care activities

  1 year

Study Arms (2)

Telephonic

EXPERIMENTAL

Tailored telephonic intervention to improve HbA1c for participants in the diabetes registry

Behavioral: telephonic

Standard registry

ACTIVE COMPARATOR

People with diabetes who are in the A1c registry may receive letters from the DOHMH to promote improved A1c and also give lists of bronx resources for healther foof and activites

Behavioral: telephonic

Interventions

telephonic BEHAVIORAL

Between 4-8 phone calls each year for health behavior counseling to improve HbA1c

Standard registry; Telephonic

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will be those patients with diabetes who speak English and/or Spanish and reside in the South Bronx.
• Subjects will be adults, \> 18 years, with diabetes, who become part of the NYC registry by virtue of having a reported HbA1c \>7% to the DOHMH.
• The sampling frame for this study comprises virtually all adults with diabetes in the South Bronx.

You may not qualify if:

• Age \< 18 years
• A1c \< = 7 %
• Refuses informed consent and HIPAA consent
• Cognitive dysfunction as assessed by telephone
• Does not read or speak English or Spanish
• No diabetes

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• New York City Department of Health and Mental Hygiene: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

New York City Department of Health & Mental Hygiene

New York, New York, 10461, United States

Location

Related Publications (3)

• Tabaei BP, Howland RE, Gonzalez JS, Chamany S, Walker EA, Schechter CB, Wu WY. Impact of a Telephonic Intervention to Improve Diabetes Control on Health Care Utilization and Cost for Adults in South Bronx, New York. Diabetes Care. 2020 Apr;43(4):743-750. doi: 10.2337/dc19-0954. Epub 2020 Mar 4.

  PMID: 32132009 DERIVED

• Chamany S, Walker EA, Schechter CB, Gonzalez JS, Davis NJ, Ortega FM, Carrasco J, Basch CE, Silver LD. Telephone Intervention to Improve Diabetes Control: A Randomized Trial in the New York City A1c Registry. Am J Prev Med. 2015 Dec;49(6):832-41. doi: 10.1016/j.amepre.2015.04.016. Epub 2015 Jul 29.

  PMID: 26232903 DERIVED

• Davis NJ, Schechter CB, Ortega F, Rosen R, Wylie-Rosett J, Walker EA. Dietary patterns in Blacks and Hispanics with diagnosed diabetes in New York City's South Bronx. Am J Clin Nutr. 2013 Apr;97(4):878-85. doi: 10.3945/ajcn.112.051185. Epub 2013 Feb 27.

  PMID: 23446901 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jeffrey S Gonzalez, PhD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2008
• First Posted: November 25, 2008
• Study Start: September 1, 2008
• Primary Completion: November 1, 2011
• Study Completion: June 1, 2012
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

US (1)