Bronx A1c: Bring it Down for Health (Bronx A1c)

June 14, 2023 updated by: Albert Einstein College of Medicine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Metabolic control of diabetes, measured by hemoglobin A1c (HbA1c), reduces the risk of microvascular complications. Health care providers frequently do not meet standards for managing HbA1c and individuals with diabetes are often not aware of their HbA1c values. To address these issues 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 individual is the unit of sampling, assignment and analysis. After eligibility is assessed and informed consent is obtained by telephone, the individual will be randomly assigned to one of the two groups. The patient telephone intervention will focus on collaborative problem solving for resolving barriers to medication adherence, improving lifestyle behaviors, and communicatiing effectively with their providers. The print materials from the DOHMH will communicate HbA1c results to patients and their providers, with strategies to improve them. 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. Psychosocial data on depression, health behaviors, and risk perceptions will be collected by telephone. 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.

Study Type

Interventional

Enrollment (Actual)

941

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10461
        • New York City Department of Health & Mental Hygiene

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telephonic
Tailored telephonic intervention to improve HbA1c for participants in the diabetes registry
Behavioral: telephonic
Between 4-8 phone calls each year for health behavior counseling to improve HbA1c
Active Comparator: Standard registry
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
Between 4-8 phone calls each year for health behavior counseling to improve HbA1c

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
diabetes self-care activities
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albert Einstein College of Medicine

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
New York City Department of Health and Mental Hygiene

Investigators

  • Principal Investigator: Jeffrey S Gonzalez, PhD, Albert Einstein College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

November 24, 2008

First Submitted That Met QC Criteria

November 24, 2008

First Posted (Estimated)

November 25, 2008

Study Record Updates

Last Update Posted (Estimated)

June 16, 2023

Last Update Submitted That Met QC Criteria

June 14, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2007-271
  • R18DK078077 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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