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Cholesterol, Hypertension and Glucose Education Study

NCT00815789 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 362

Last updated 2023-11-15

No results posted yet for this study

Summary

The goal of this study is to improve cardiovascular disease (CVD) and cholesterol in African Americans adults with diabetes by addressing the modifiable risk factors of systolic blood pressure (SBP), glycosylated hemoglobin (Hb A1c), and low-density lipoprotein cholesterol (LDL-C). We will evaluate the impact of a tailored CVD risk management intervention administered by nurses via the telephone. The intervention incorporates medication management and behavioral modification and will be tailored to the needs of vulnerable high risk subjects (e.g. African Americans, low socioeconomic status, low literate). It will be integrated into community clinics, thereby enhancing the potential for benefit and generalizability to other settings.

The primary hypothesis is that among African American subjects with diabetes, a nurse administered, tailored cardiovascular risk management intervention targeting both medication management and behavioral patient self-management will decrease SBP by 5 mmHg, Hb A1c by 0.5%, and LDL-C by 20 mg/dl over 12 months relative to the cardiovascular education-only control group.

Conditions

Interventions

BEHAVIORAL

Tailored cardiovascular risk management (Nurse-administered )

A nurse-administered intervention, which includes a behavioral and a medication management component. The intervention consists of very brief monthly telephone calls and occurs over 12 months. Upon request, participants may also be mailed additional supportive educational material to supplement phone intervention. They will also receive a letter clarifying medications reviewed with them during the nurse-administered intervention.

Sponsors & Collaborators

  • The Kate B. Reynolds Charitable Trust

    collaborator OTHER

  • Duke University

    lead OTHER

Principal Investigators

  • Hayden B Bosworth, PhD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2011-03-31
Completion
2011-12-31

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00815789 on ClinicalTrials.gov