Healia Clinical Trials Information Database

Prevention of Cardiovascular Outcomes in African Americans With Diabetes

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.

Description

We will recruit eligible subjects who have an upcoming primary care visit with their primary care provider. Subjects will first be mailed letters, signed by a member of their own primary care team (in these clinics, patients are usually under the care of a team and not one physician) or the Clinic Medical Director in the absence of a primary team member, requesting their participation in the study. Subjects can call a toll-free number to request not to be contacted or if they have any questions (opt-out strategy similar to prior studies approved by Duke’s IRB). The research assistant will contact the subject by telephone to explain the study, screen for eligibility, arrange an in-person meeting at the clinic to further describe the study, obtain informed consent and interview the subject. Enrollment will be scheduled at a time when individuals will already be coming to their clinic and all subsequent outcome assessment will be obtained from medical records (e.g., blood pressure, Hb A1c, and LDL-C, BMI) and secondary outcomes (e.g., behaviors will be obtained over the telephone).

Upon enrollment, each eligible, consenting subject will be surveyed about demographics, health behaviors (exercise, diet, medication compliance and treatment barriers), social and medical environment (experiences of discrimination, John Henryism, PHQ2, social support and stress, diabetes knowledge and communication). The entire interview would take approximately 60-90 minutes. If the interview cannot be completed at that time, we will ask permission to call the subject at home to complete the interview. After subjects have completed the measurement battery, they will be randomly assigned to be in one of the two groups. The entire study randomization will occur before patient enrollment begins and this will be maintained in a central site away from the enrollment site.

At either a 12-month follow-up visit or via a phone call, all subjects will once again be surveyed (30-60 minutes) to determine secondary outcome variables including changes in health behaviors, and adherence to recommended regimens. In addition, the cost-effectiveness of the intervention will be assessed at the conclusion of the study.

Status: Enrolling by invitation (N/A). Started on December 1st, 2008. Ended on July 1st, 2011.

Enrollment: 450 subjects

Study Type: Interventional

Study Design:

  • Health Services Research
  • Randomized
  • Single Blind (Outcomes Assessor)
  • Uncontrolled
  • Parallel Assignment

Conditions:

Interventions:

  • Behavioral: Tailored cardiovascular risk management (Nurse-administered )

Eligibility

Inclusion Criteria:

  • Enrolled in one of the three primary care clinics for at least one year

  • Diagnosis ICD (250.xx) in the prior year

  • 18 years of age and older.

Exclusion Criteria:

  • Hospitalized for a stroke, myocardial infarction, coronary artery revascularization in the past 6 months

  • Receiving or planning to receive dialysis for end stage renal disease

  • Diagnosis of metastatic cancer

  • Active diagnosis of psychosis documented in medical record

  • Does not have access to a telephone

  • Refusal to provide informed consent

  • Resident in nursing home or receiving home health care

  • Severely impaired sight, hearing or speech

  • Planning to leave the area prior to the anticipated end of participation

  • Pregnant or planning to become or breast feeding.

Gender

Both

Mininum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

No


Resources

Source: Duke University

Authority: United States: Institutional Review Board

Locations

  • Duke University Health Care System
    Durham
    North Carolina
    27705
    United States

Officials

  • Hayden B Bosworth, PhD (Principal Investigator, Duke University)

Sponsors

  • Duke University (Lead Sponsor)

  • The Kate B. Reynolds Charitable Trust (Collaborator)

References

None.

Links

None.


Date Verified
December 1st, 2008
First Received
December 29th, 2008
Last Changed
December 29th, 2008

Information obtained from ClinicalTrials.gov on December 30, 2008. Link to the current ClinicalTrials.gov record.


All data in the Healia Clinical Trials Information Database and content displayed by the Healia Clinical Trials Search Engine are licensed from the National Institutes of Health (National Library of Medicine), which collects and maintains the data.

The Healia Clinical Trials Search Engine searches the data set at clinicaltrials.gov, providing up-to-date information about current clinical trials. In the Healia Clinical Trials Database you can find information on new experimental drugs, medical devices, and other types of treatments for all types of diseases. Each clinical trial description includes information about the phase of the trial (phase I, phase II, or phase III), the trial’s methods, such as whether it is a randomized, placebo controlled, double blind study, and the status of the trial including whether or not the trial is currently enrolling new participants.


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