Bronx A1c: Bring it Down for Health

This study has been completed.
Sponsor:
Collaborators:
New York City Department of Health and Mental Hygiene
Information provided by (Responsible Party):
Elizabeth Walker, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT00797888
First received: November 24, 2008
Last updated: September 5, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Type 2 Diabetes
Behavioral: telephonic

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Bronx A1c: Bring it Down for Health

Resource links provided by NLM:


Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:
  • HbA1c [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • diabetes self-care activities [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 941
Study Start Date: September 2008
Study Completion Date: June 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00797888

Locations
United States, New York
New York City Department of Health & Mental Hygiene
New York City, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
New York City Department of Health and Mental Hygiene
Investigators
Principal Investigator: Elizabeth A Walker, PhD, RN Albert Einstein College of Medicine of Yeshiva University
  More Information

No publications provided by Albert Einstein College of Medicine of Yeshiva University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Elizabeth Walker, Professor of Medicine and Epidemiology & Population Health, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT00797888     History of Changes
Other Study ID Numbers: CCI 2007-271, R18DK078077
Study First Received: November 24, 2008
Last Updated: September 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Albert Einstein College of Medicine of Yeshiva University:
diabetes
behavioral intervention
HbA1c
health disparities

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 01, 2014