Case Managers for CVD Risk Reduction in HIV Clinic

Study Overview
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Brief Summary
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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
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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).

Official Title
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A Clinic-Based Case Manager Administered Telephone Intervention to Reduce Cardiovascular Disease Risk in Persons Living With HIV

Conditions
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Cardiovascular Disease, HIV

Intervention / Treatment
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* Behavioral: Telephone
* Other: Educational pamphlets


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Educational pamphlets + telephone<br> | Behavioral: Telephone<br>* 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.<br>Other: Educational pamphlets<br>* 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.<br>|
| Active Comparator: Educational pamphlets<br> | Other: Educational pamphlets<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | baseline, 24 weeks, 48 weeks, 72 weeks | 
| Change in fasting LDL-c levels | Assessment of the absolute change in fasting calculated low density lipoprotein cholesterol over the study period. | baseline, 24 weeks, 48 weeks, 72 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total weight loss | Total weight loss from baseline over the study period. | 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. | baseline, 24 weeks, 48 weeks, 72 weeks |