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Bronx A1c: Bring it Down for Health
NCT00797888 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- BEHAVIORAL telephonic
Study Locations (1)
New York
- New York City Department of Health & Mental Hygiene — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 941 participants |
| Start Date | 2008-09 |
| Est. Completion | 2012-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00797888
The ClinicalTrials.gov registry entry for NCT00797888 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 941 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Albert Einstein College of Medicine, which has 73 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Type 2 Diabetes appearing as the primary indexed condition, and to 1 intervention — of which telephonic is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00797888 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00797888 about?
NCT00797888 is a clinical study titled "Bronx A1c: Bring it Down for Health". 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 con...
What is the current status of trial NCT00797888?
This trial is currently completed. It is a NA study. The enrollment target is 941 participants. The study started on 2008-09. Estimated completion is 2012-06.
What conditions does trial NCT00797888 study?
This clinical trial studies the following conditions: Type 2 Diabetes. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00797888?
The interventions under investigation include: telephonic (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00797888?
This trial is sponsored by Albert Einstein College of Medicine, which has 73 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00797888 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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