The purpose of the study is to assess the efficacy of a case manager/social worker administered, telephone-based educational curriculum in improving cardiovascular disease related outcomes among HIV-infected clinic patients.
Fifty high Cardiovascular Disease Risk (CVD) risk clinic patients will be randomized 1:1 to receive either a series of educational pamphlets on CVD risk reduction plus a telephone-based CVD risk reduction curriculum delivered over 24 weeks \[intervention arm\], or the educational pamphlets alone \[control arm\]. Anthropomorphic data, blood pressure and lipid profiles will be obtained from patients to assess the efficacy of the intervention in reducing blood pressure and serum low-density lipoprotein levels (LDL).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
50
A series of educational pamphlets on CVD risk reduction plus a telephone-based CVD risk reduction curriculum will be administered by Clinic-Based Case Managers (CCMs). Six modules will be given over 24 weeks in a rotating fashion on topics relevant to CVD risk. Subjects will be given the pamphlets every 2 weeks corresponding with the first time they receive the telephone - based module.
A series of 6 handouts will be given to controls once monthly over 6 months on the same topics presented in the telephone modules. Educational packets will be primarily drawn from free printed material available at www.learningaboutdiabetes.org and the American Heart Association website.
Duke University Medical Center
Durham, North Carolina, United States
Change in Ambulatory Systolic Blood Pressure
Change of systolic blood pressure will be assessed as an absolute continuous variable, and as a proportion or persons who achieve \>5mmHg reduction in systolic blood pressure from baseline. Reported here is the change from baseline to 72 weeks.
Time frame: Baseline, 24 weeks, 48 weeks, 72 weeks
Number of Participants Who Achieve >5mmHg Reduction in Systolic Blood Pressure From Baseline
Time frame: Baseline, 72 weeks
Change in Non-HDL (High Density Lipoprotein Cholesterol) Levels
Assessment of the absolute change in fasting calculated non-high density lipoprotein cholesterol over the study period. Reported here is the change from baseline to 72 weeks.
Time frame: Baseline, 24 weeks, 48 weeks, 72 weeks
Total Change in Body Weight
Total change in body weight from baseline over the study period. Reported here is the change from baseline to 72 weeks.
Time frame: Baseline, 24 weeks, 48 weeks, 72 weeks
Change in 10-year Atherosclerotic Cardiovascular Disease (ASCVD) Risk Score
The global cardiovascular disease risk as calculated by the American College of Cardiology/American Heart Association's 10-year risk calculator. The ASCVD risk score is a calculation of the 10-year risk of having a cardiovascular problem, such as a heart attack or stroke. The ASCVD risk score is given as a percentage, which represents the chance of having heart disease or stroke in the next 10 years. 0 to 4.9 = low risk, 5 to 7.4 = borderline risk, 7.5 to 20 = intermediate risk, \>20 = high risk. Reported here is the change from baseline to 72 weeks.
Time frame: Baseline, 24 weeks, 48 weeks, 72 weeks
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