Case Managers for CVD Risk Reduction in HIV Clinic

Duke University

Status: Completed

Conditions: HIV; Cardiovascular Disease

Treatments: Behavioral: Telephone; Other: Educational pamphlets

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03839394

Pro00085562

K23HL137611-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 50 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Educational pamphlets + telephone

Experimental group

Treatment:

Other: Educational pamphlets

Behavioral: Telephone

Educational pamphlets

Active Comparator group

Treatment:

Other: Educational pamphlets