Case Managers for CVD Risk Reduction in HIV Clinic

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease; HIV
• Intervention / Treatment: Behavioral: Telephone; Other: Educational pamphlets

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27701
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Educational pamphlets + telephone	Behavioral: Telephone; 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.; Other: Educational pamphlets; 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.
Active Comparator: Educational pamphlets	Other: Educational pamphlets; 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.

What is the study measuring?

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. Reported here is the change from baseline to 72 weeks.	Baseline, 24 weeks, 48 weeks, 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	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.	Baseline, 24 weeks, 48 weeks, 72 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline, 24 weeks, 48 weeks, 72 weeks

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Nwora L Okeke, MD, MPH, Duke University

Publications and helpful links

Helpful Links

• Website referring to educational materials to be shared as part of this intervention
• Website referring to educational materials to be shared as part of this intervention

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2020
• Primary Completion (Actual): September 14, 2023
• Study Completion (Actual): September 14, 2023

Study Registration Dates

• First Submitted: February 11, 2019
• First Submitted That Met QC Criteria: February 11, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): September 24, 2024
• Last Update Submitted That Met QC Criteria: August 28, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: Pro00085562; K23HL137611-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No