A Clinic-Based Case Manager Administered Telephone Intervention to Reduce Cardiovascular Disease Risk in Persons Living With HIV
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiovascular Disease
- Sponsor
- Duke University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change in Ambulatory Systolic Blood Pressure
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •In care at the Duke Infectious Diseases Clinic for HIV and for at least 24 months
- •On antiretroviral therapy
- •2013 American Heart Association 10-year ASCVD risk score ≥ 15%, with a diagnosis of either hypertension or hyperlipidemia
- •English literate (able to speak and read at a 6th grade level)
- •Subjects must have the capacity to give legally effective consent.
Exclusion Criteria
- •Patients with prior diagnosis of acute coronary syndrome, stroke, peripheral vascular disease, and end stage renal disease
Outcomes
Primary Outcomes
Change in Ambulatory Systolic Blood Pressure
Time Frame: Baseline, 24 weeks, 48 weeks, 72 weeks
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.
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
Time Frame: Baseline, 24 weeks, 48 weeks, 72 weeks
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.
Secondary Outcomes
- Total Change in Body Weight(Baseline, 24 weeks, 48 weeks, 72 weeks)
- Change in 10-year Atherosclerotic Cardiovascular Disease (ASCVD) Risk Score(Baseline, 24 weeks, 48 weeks, 72 weeks)