Case Managers for CVD Risk Reduction in HIV Clinic

Not Applicable

Completed

• Conditions: Cardiovascular Disease; HIV
• Interventions: Behavioral: Telephone; Other: Educational pamphlets

• Registration Number: NCT03839394
• Lead Sponsor: Duke University

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).

Study Timeline

• Study First Submitted: 2019-02-11
• Study First Submitted QC: 2019-02-11
• Study First Posted: 2019-02-15
• Study Start: 2020-10-12
• Primary Completion: 2023-09-14
• Study Completion: 2023-09-14
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Educational pamphlets + telephone	Telephone	-
Educational pamphlets + telephone	Educational pamphlets	-
Educational pamphlets	Educational pamphlets	-

Primary Outcome Measures

Name	Time	Method
Change in Ambulatory Systolic Blood Pressure	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	Baseline, 72 weeks
Change in Non-HDL (High Density Lipoprotein Cholesterol) Levels	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 Outcome Measures

Name	Time	Method
Total Change in Body Weight	Baseline, 24 weeks, 48 weeks, 72 weeks	Total change in body weight from baseline over the study period. Reported here is the change from baseline to 72 weeks.
Change in 10-year Atherosclerotic Cardiovascular Disease (ASCVD) Risk Score	Baseline, 24 weeks, 48 weeks, 72 weeks	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.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States