Please select the eligibility criteria that correspond to the clinical trial below.
Title: Prevention of Cardiovascular Outcomes in African Americans With Diabetes
Brief 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.


Options:
A: Inclusion Criteria:

* Patient with diagnosed diabetes
* Seen in the office of a participating family physician at least once between July 2009 and April 2010
* At high risk for cardiovascular events:

  * Previous cardiovascular disease (including AMI, angina, stroke, TIA, claudication); or
  * Men aged \>= 45 years, women aged \>= 50 years; or
  * Men aged \< 45 years, women aged \< 50 years with at least one of the following:

    1. Macrovascular disease (silent myocardial infarction, or evidence of peripheral arterial, carotid or cerebrovascular disease)
    2. Microvascular disease (nephropathy or retinopathy)
    3. Family history of premature coronary or cerebrovascular disease in a first-degree relative
    4. Duration of diabetes \> 15 years with age \> 30 years
B: Inclusion Criteria:

* aged ≥ 19 years;
* android smartphone users;
* no changes in medication for diabetes for at least 6 months;
* HbA1c levels ≥6.5% within the last 3 months.

Exclusion Criteria:

* currently had serious concomitant disease other than diabetes (n=1); malignancy-related histories on admission, myocardial infarction, cerebral infarction or organ transplantation;
* pregnant or had plans for pregnancy within 6 months;
* plans to participate in other clinical studies or illiteracy.
C: Inclusion Criteria:

1. enrolled for primary care at a VA Pittsburgh Healthcare System (VAPHS)site with at least one visit from June 1, 2004 through December 31, 2005
2. diagnosed with diabetes mellitus with at least 12 months of ongoing pharmacologic treatment (at least one oral hypoglycemic agent, insulin, or both)
3. born in 1926 or later
4. have an HbA1c level \>/= 8.0% at the last assessment (between 6/1/04 and 12/31/05)
5. have an HbA1c level \>/= 7.5% (by finger stick) at the time of enrollment
6. mentally competent to give informed consent

Exclusion Criteria:

1. one or more visits to the VAPHS Diabetes Clinic from June 1, 2004 through December 31, 2005
2. metastatic or inoperable cancer
3. Child-Pugh Class B or C end-stage liver disease
4. HIV/AIDS
5. end-stage renal disease requiring dialysis
6. ongoing home oxygen therapy
7. a history of major organ transplant (i.e., heart, lung, kidney, liver)
8. residence in an institution (e.g. nursing home, personal care home, or prison)
9. incompatible telephone service (i.e., either none or digital)
10. concurrent participation in any other research protocol
D: 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.

Answer: D