Clinical trial NCT00797888: Bronx A1c: Bring it Down for Health
Official title: Bronx A1c: Bring it Down for Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: diabetes
behavioral intervention
HbA1c
health disparities
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: New York City Department of Health and Mental Hygiene
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2008-11-25
Enrollment: 941
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 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

Primary outcomes:
measure: HbA1c
timeFrame: 1 year
Secondary outcomes:
measure: diabetes self-care activities
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: New York City Department of Health & Mental Hygiene
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Jeffrey S Gonzalez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.