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NCT00797888 · ClinicalTrials.gov registry record · NA

Bronx A1c: Bring it Down for Health

A NA study of Type 2 Diabetes, sponsored by Albert Einstein College of Medicine.

Completed
Registry status
NA
Development phase
941
Enrollment target
1
Study location

NCT00797888 is a NA study of Type 2 Diabetes that has completed, run by Albert Einstein College of Medicine. The registered enrollment target is 941 participants, below the 1,099-participant average among 288 other Type 2 Diabetes trials with a reported enrollment target (14% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00797888, a NA study of Type 2 Diabetes, has completed, sponsored by Albert Einstein College of Medicine.

COMPLETED
Registry status
NA
Development phase
941 participants
Enrollment target
1
Study location

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

FieldValue
Enrollment Target 941 participants
Start Date 2008-09
Est. Completion 2012-06
Phase NA

Sponsor

Albert Einstein College of Medicine

175 total trials

What the Registry Record Tells You About NCT00797888

The ClinicalTrials.gov registry entry for NCT00797888 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 941 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,099-participant average among 288 other Type 2 Diabetes trials with a reported enrollment target (14% lower). The listed sponsor is Albert Einstein College of Medicine, which has 175 total studies on file at ClinicalTrials.gov.

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.

NCT00797888 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

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.

What interventions are being tested in trial NCT00797888?

The interventions under investigation include: telephonic (BEHAVIORAL).

Who is sponsoring clinical trial NCT00797888?

This trial is sponsored by Albert Einstein College of Medicine, which has 175 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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